Agenus gegen Malaria - 500 Beiträge pro Seite

[Shanghai2006]

AGEN is popular because of the glioblastoma cancer vaccine - but today the stock is surging on news about their malaria vaccine.

In August the CEO bought $1M worth of shares. They recently had to do a reverse split to keep from getting delisted. And they still have a lot of costs. But this is good news.

Nice 2 page Xconomy article:
Agenus Rejoices Over Positive Trial of Partner Glaxo’s Malaria Vaccine
Arlene Weintraub 10/18/11
Today European drug giant GlaxoSmithKline (NYSE: GSK) announced that the prestigious New England Journal of Medicine published results from a late-stage trial of its malaria vaccine, which showed that the vaccine provided significant protection against the disease in young African children. The results were announced in Seattle at a forum hosted by the Bill & Melinda Gates Foundation.

More than 3,000 miles away, the 60 employees of Lexington, MA-based Agenus (NASDAQ: AGEN) celebrated the experimental vaccine. Why? Because the vaccine, called RTS,S, is made with an immune-system-boosting plant extract that Glaxo licenses from Agenus.

Agenus is providing the extract, called QS-21 Stimulon adjuvant, for four GSK products that are in late-stage development. As those programs advance, Agenus will receive milestone payments and, for each product that makes it to market, it will receive royalties for 10 years after launch. The financial specifics haven’t been disclosed, but Agenus CEO Garo Armen says, “Our financial gain a few years out, if all these are successful, would be very very substantial.”

[Shanghai2006]

Armen hopes the news about Glaxo’s malaria vaccine will help the company regain investors’ confidence. Agenus acquired QS-21 in 2000, when it bought a Framingham, MA company called Aquila Biopharmaceuticals for $40 million. QS-21 is a chemical extracted from the soap bark tree, an evergreen native to Chile. About 15 drugs containing Agenus’ QS-21 product are in late-stage trials, including a Glaxo cancer vaccine and an Alzheimer’s treatment being developed by Johnson & Johnson. In addition, Agenus is developing a herpes vaccine that contains QS-21.

But the opportunity presented by Glaxo’s malaria vaccine is particularly large. Malaria kills 800,000 people a year, mostly in Africa. There is no effective vaccine on the market, and Glaxo—which has been working on RTS,S since 1987—is ahead of the pack in its development program. The trial announced today showed that RTS,S reduced the risk of severe malaria by 47 percent for 12 months following vaccination. Glaxo plans to report further results next year, as well as data on long-term protection in 2014. The World Health Organization has said it could make a policy recommendation for vaccination with RTS,S as early as 2015.

RTS,S works by preventing the malaria parasite from infecting and then multiplying in the liver, and from infecting red blood cells. Glaxo scientists created it by fusing two proteins, one of which is used in the company’s hepatitis B vaccine. Then it used a proprietary technology to further enhance the immune response—a technology platform that includes Agenus’ QS-21.

In the short term, Agenus is still facing some significant challenges. In the first six months of the year, Agenus lost $12 million on $1.5 million in sales. The company’s experimental cancer vaccine, vitespen (Prophage) has shown promise in mid-stage trials in patients with glioma and melanoma, Armen says, but the company will have to secure partnerships to help finance all the trials necessary to gain FDA approval.

And it could be facing competition on QS-21. Other companies are developing vaccine adjuvants, including New York-based Adjuvance Technologies, which is in mid-stage trials of a synthetic version of QS-21—a product that can be made in a lab rather than extracted from the soap bark tree.

Armen is the first to admit that the onus is on him to prove Agenus is on the right track. But his faith in the company he has nursed along for nearly two decades is unwavering. “I’m one of the few CEOs in the industry who has spent over $13 million net of my compensation to finance this company personally,” he says. “It’s not funny money—it’s real money.”

Most recently, in August, Armen picked up 2.1 million shares of his company at an average price of $0.51 a piece.

[Shanghai2006]

Biotech stocks as a whole tend to underperform after the annual American Society of Clinical Oncology (ASCO) conference in June. Many investors buy biotech up to the conference, which has many releases of clinical data, and then some investors lose part of their excitement. But one month later (i.e., around now), there may be opportunities for gains.

Over the last 10 years, the biotech sector fell 1.84% in the month following the ASCO Conference, but three months out the industry had risen 4.95%. Over six months following the conference, the industry was up 8.1% on average.

The hard crash after ASCO often results from investors selling the news, rather than any data that lowers a drug's approvability or sales potential.

Use this list as a starting-off point for your own analysis.

1. Teva Pharmaceutical: Drug Manufacturers Industry. Market cap of $44.51B. Performance over the last month at 1.02%. The stock has lost 10.85% over the last year.

2. Vertex Pharmaceuticals: Drug Manufacturers Industry. Market cap of $10.34B. Performance over the last month at 11.16%. The stock has had a good month, gaining 11.16%.

3. Biogen Idec: Biotechnology Industry. Market cap of $25.22B. Performance over the last month at 5.85%. The stock has gained 89.87% over the last year.

4. Agenus (Nasdaq: AGEN ) : Biotechnology Industry. Market cap of $86.74M. Performance over the last month at -2.53%. The stock has gained 1.32% over the last year.

5. Cyclacel Pharmaceuticals (Nasdaq: CYCC ) : Biotechnology Industry. Market cap of $52.61M. Performance over the last month at -10.32%. The stock is currently stuck in a downtrend, trading 10% below its SMA20, 18.56% below its SMA50, and 23.16% below its SMA200. It's been a rough couple of days for the stock, losing 9.6% over the last week.

6. Exelixis (Nasdaq: EXEL ) : Biotechnology Industry. Market cap of $1.09B. Performance over the last month at -6.56%. The stock is a short squeeze candidate, with a short float at 10.09% (equivalent to 8.14 days of average volume). The stock has gained 178.5% over the last year.

7. Incyte (Nasdaq: INCY ) : Biotechnology Industry. Market cap of $2.42B. Performance over the last month at 6.47%. This is a risky stock that is significantly more volatile than the overall market (beta = 2.39). The stock is a short squeeze candidate, with a short float at 11.82% (equivalent to 8.54 days of average volume). The stock has gained 61.78% over the last year.

8. Neoprobe (Nasdaq: NEOP ) : Medical Appliances & Equipment Industry. Market cap of $293.07M. Performance over the last month at -2.65%. The stock is a short squeeze candidate, with a short float at 14.37% (equivalent to 8.03 days of average volume). The stock has gained 74.6% over the last year.

9. Nektar Therapeutics (Nasdaq: NKTR ) : Biotechnology Industry. Market cap of $846.47M. Performance over the last month at -3.01%. The stock is a short squeeze candidate, with a short float at 10.01% (equivalent to 10.83 days of average volume). The stock has lost 38.17% over the last year.

10. OncoGenex Pharmaceuticals (Nasdaq: OGXI ) : Diagnostic Substances Industry. Market cap of $154.65M. Performance over the last month at -7.34%. This is a risky stock that is significantly more volatile than the overall market (beta = 2.11). The stock is a short squeeze candidate, with a short float at 5.07% (equivalent to 7.52 days of average volume). The stock has gained 32.03% over the last year.

[Shanghai2006]

Agenus, Inc. (AGEN), today announced that it is set to join the broad-market Russell 3000(R) Index, Russell Global Index, and Russell Microcap(R) Index when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 25, according to a preliminary list of additions on www.russell.com.

[Shanghai2006]

Agenus, Inc. (AGEN) today announced that GlaxoSmithKline's (GSK) herpes zoster vaccine candidate (HZ/su), which contains Agenus' QS-21 Stimulon(R)1 adjuvant as a component of GSK's adjuvant system, has commenced a global, randomized, placebo-controlled Phase 3 clinical trial for the prevention of shingles (herpes zoster) in immunocompromised patients. This study will include approximately 200 clinical sites and enroll more than 1,400 patients 18 years of age or older undergoing hematopoietic stem cell transplantation (HCT). Herpes zoster, which can occur as a complication of HCT, has limited treatment and prevention options available.

The immunocompromised study is part of a Phase 3 clinical program that began in August 2010 and was previously announced by GSK. This program includes a global, randomized, placebo-controlled Phase 3 clinical study with the HZ/su vaccine, which contains QS-21, for the prevention of shingles and post-herpetic neuralgia in over 30,000 adult patients. Patient enrollment for this study has completed.

QS-21 is an important component in a number of investigational vaccine formulations addressing a wide variety of indications, including infectious diseases, cancers, and Alzheimer's disease. Agenus is generally entitled to receive milestone payments as QS-21-containing programs advance, as well as royalties for 10 years after commercial launch, with some exceptions.

"There are currently 16 QS-21 containing vaccines in clinical development and we look forward to significant news flow from our partners with pivotal data readouts expected from at least four key clinical programs that incorporate QS-21," said Garo H. Armen, Ph.D., chairman and CEO of Agenus.

About QS-21 Stimulon Adjuvant

Agenus' QS-21 Stimulon adjuvant is one of the most widely tested vaccine adjuvants under development. QS-21 is designed to strengthen the body's immune response to a vaccine's antigen, thus making it more effective. QS-21 is a key component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to play an important role for several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. Licensees of QS-21 include GSK, Janssen Alzheimer Immunotherapy, and Integrated Biotherapeutics.

Between Agenus and its partners, a total of 18 vaccine programs are in clinical development of which 16 contain QS-21. They include, but are not limited to:

Phase 3: GSK's RTS,S for malaria2
Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with resected melanoma2
Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with resected non-small cell lung cancer2
Phase 3: GSK's HZ/su for shingles2
Phase 2: Janssen's ACC-001 for Alzheimer's disease
Agenus' pipeline programs include:

Phase 2: Prophage Series G-100 for newly diagnosed glioma
Phase 2: Prophage Series G-200 for recurrent glioma
Phase 2-Ready: HerpV (contains QS-21) for genital herpes

[Shanghai2006]

Agenus Inc. (AGEN) was launched back into the spotlight late last year when news circulated the wires that the company's QS-21-Stimulon vaccine adjuvant was being used by GlaxoSmithKline (GSK) in a high-profile malaria vaccine that, at the time, was receiving a huge amount of media coverage thanks to some positive late stage trial results.

The attention paid Agenus following those reports also brought to light for many investors the fact that Stimulon was being used in multiple late-clinical-stage vaccine candidates and would receive a royalty of any potential sales registered by those vaccines. While that revenue potential alone would not likely be enough to justify an investment in AGEN as a stand-alone entity, especially not over the near term as Glaxo stated its intention to not profit from the malaria vaccine, a revised partnership deal between Glaxo and Agenus had to buyout rumors swirling.

According to the revised deal, GSK would be granted a 'first right of refusal' in the event of an Agenus buyout, or if certain of Agenus properties were to be on the bidding block, namely QS-21 and/or the cancer immunotherapy treatment Prophage that is currently being tested in the treatment of glioma. Also as result of the agreement, the wording at the time stated taht, "GSK will pay Agenus a non-refundable payment of $9 million, of which $2.5 million is creditable against future manufacturing technology transfer royalty payments. The agreement also includes royalty payments for an undisclosed indication upon commercialization of a vaccine product."

These developments provided a much-needed boost for Agenus shares, which rallied from near the two dollar level at one point to over seven. In fact, shares had been on the move for the better part of the early portion of 2012 before settling down and hovering at around the five dollar market of today. (18 July 2012)

Thanks to the Glaxo news, some buyout talk and revised partnership, it was apparent that AGEN was once again for real. Since then, however, it's been another period of relative silence as the Progphage trials develop.

The company did release an update this week, though, reporting on the initiation of a Phase III trial for GSK's herpes zoster vaccine candidate that utilizes QS-21. Probably more importantly, however, was the broad update offered by AGEN, that highlighted the 16 different vaccines of which QS-21 is a part.

[Shanghai2006]

Agenus Inc. (AGEN) will release its second quarter financial results before the market opens on August 2, 2012.

Agenus executives will host a conference call at 11:00 a.m. Eastern Time that same day. To access the live call, dial 877.475.3568 (domestic) or 678.809.3092 (international); the access code is 10811038. The call will also be webcast and will be accessible from the company's website at www.agenusbio.com/webcast/. A replay will be available approximately two hours after the call through midnight Eastern Time on February 3, 2013. The replay number is 855.859.2056 (domestic) or 404.537.3406 (international), and the access code is 10811038. The replay will also be available on the company's website approximately two hours after the live call.

[Shanghai2006]

QS-21 Stimulon Adjuvant

QS-21 Publications


QS-21 Stimulon® adjuvant is designed to strengthen the body's immune response to a vaccine's antigen, thus making it more effective.

The New England Journal of Medicine has published results from a Phase 3 trial of GSK's malaria vaccine. This vaccine contains Agenus QS-21 Stimulon adjuvant as a key component.

Press Release
QS-21 Fact Sheet
Malaria facts from Malaria Policy Center
RTS,S Malaria Vaccine Fact Sheet
RTS,S Safety and Efficacy Fact Sheet
Agenus Corporate Fact Sheet
GSKvision's Youtube Channel
GSK: Developing the Malaria Vaccine Candidate
QS-21 Publications
GlaxoSmithKline Website
The New England Journal of Medicine Website



--------------------------------------------------------------------------------

QS-21 Stimulon® Adjuvant Pipeline

[Shanghai2006]

http://www.agenusbio.com/images/images_product/qs21-pipeline…

[Shanghai2006]

Under the terms of the agreement, GSK will pay Agenus a non-refundable payment of $9
million, of which $2.5 million is creditable against future manufacturing technology
transfer royalty payments. The agreement also includes royalty payments for an
undisclosed indication upon commercialization of a vaccine product.
“Today’s announcement further validates QS-21 as a key adjuvant while expanding its
potential use in another important indication,” stated Garo Armen, Ph.D., chairman and
CEO of Agenus. “With over a dozen clinical programs in development containing our
adjuvant, we are pleased to be able to contribute to the future development of a broad
range of vaccines.”
Saponin Platform: QS-21 Stimulon® Adjuvant
QS-21 Stimulon® adjuvant is designed to strengthen the body's immune response to a
vaccine's antigen, thus making it more effective. QS-21 has become a critical component
in the development of investigational preventive vaccine formulations across a wide
variety of investigational prophylactic and therapeutic vaccines. Licensees of QS-21
include GSK, Janssen Alzheimer Immunotherapy, and Integrated Biotherapeutics.
Agenus is generally entitled to receive milestone payments as QS-21-containing
programs advance as well as royalties on sales of products.
Data from Phase 3 pivotal trials of four GSK vaccine candidates, which include MAGEA3
Cancer immunotherapeutic (CI) for selected patients with non-small cell lung cancer,
and melanoma, RTS,S for malaria, and Herpes Zoster for shingles, are anticipated to be
released over the next year or so.
Between Agenus and its partners, 18 programs are in clinical development, including
many programs that contain QS-21 Stimulon adjuvant. QS-21 is being studied in clinical
trials for 15 vaccine programs. They include:
• Phase 3: GSK’s RTS,S for malaria**
• Phase 3: GSK’s MAGE-A3 CI for selected patients with resected melanoma**
• Phase 3: GSK’s MAGE-A3 CI for selected patients with resected non-small cell
lung cancer**
• Phase 3: GSK’s Herpes Zoster for shingles**
• Phase 2: Janssen’s*** ACC-001 for Alzheimer’s disease
Agenus’ pipeline programs include:
• Phase 2: Prophage Series G-100 for newly diagnosed glioma
• Phase 2: Prophage Series G-200 for recurrent glioma
• Phase 2-Ready: HerpV (contains QS-21) for genital herpes

[Shanghai2006]

HerpV is the most advanced HSV-2 vaccine currently in clinical development for the treatment of genital herpes.
“This is the first evidence that a therapeutic genital herpes vaccine has elicited both CD4+ and CD8+ T-cell responses in humans,” said Anna Wald, MD, MPH, Professor of Medicine, Epidemiology and Laboratory Medicine, University of Washington, Member, Fred Hutchinson Cancer Research Center, and lead author of the manuscript. “We are very encouraged by these clinical results as published literature suggest that cellular immunity needs to be stimulated for successful treatment of genital herpes – a physically painful and emotionally debilitating disease that affects one in six adults in the US.”
In this four-arm Phase 1 study, 35 herpes simplex virus type 2 seropositive patients received the vaccine plus QS-21 (HerpV), vaccine without QS-21, QS-21 alone, or placebo. Patients received three treatments at two-week intervals.
All patients who were evaluable for immune response and received HerpV showed a statistically significant CD4+ T cell response (100%; 7/7) to HSV-2 antigens as detected by IFNγ Elispot, and the majority of those patients demonstrated a CD8+ T cell response (75%; 6/8). The vaccine was well tolerated, with injection site pain as the most
commonly reported adverse event.
Agenus plans to advance HerpV into a Phase 2 study in 2012 that will measure the effect of vaccination on viral shedding in individuals infected with HSV-2. Experts in HSV-2 clinical research believe that a reduction in viral shedding could translate into clinical
benefit.
“The publication of our herpes vaccine results marks the beginning of an exciting period,” stated Garo Armen, Ph.D., chairman and CEO of Agenus. “Over the next 18 months, we expect pivotal data from multiple important clinical programs that incorporate QS-21, which are being developed by our corporate partners.”
The HerpV study results appear in an article titled “Safety and immunogenicity of long HSV-2 peptides complexed with rhHsc70 in HSV-2 seropositive persons,". Earlier this year, the results of preclinical studies of HerpV were also published in Vaccine in a separate manuscript titled, “A heat shock protein based polyvalent vaccine targeting HSV-2: CD4(+) and CD8(+) cellular immunity and protective efficacy.”
About Herpes
According to the Centers for Disease Control, genital herpes affects more than 60 million Americans—or 1 in 6 people between ages 14 and 49—with an additional 1.5 million new cases each year.1 This disease often results in recurrent painful sores in the genital area.2 The emotional consequences of genital herpes are quite significant, as 82 percent of people in the study reported depression, 75 percent experienced fear of rejection, 69 percent cited feelings of isolation and 55 percent reported fear of discovery -- all due to infection.3 Current therapies involve taking a daily medication that only partly
suppresses the virus.
About HerpV
HerpV is a recombinant therapeutic vaccine for the treatment of genital herpes, which is caused by the herpes simplex virus-2 (HSV-2). The vaccine is based on Agenus' heat shock protein (HSP) platform technology, and contains Agenus’ proprietary adjuvant QS-21 Stimulon® adjuvant. HSPs, also called stress proteins, are found in all cells (normal cells, cancer cells and infected cells) and recent research has demonstrated that HSPs play an essential role in the presentation of pieces of proteins (or peptides) on the cell surface
to help the immune system recognize diseased cells. While the initial focus of development has been in HSV-2, the HSP technology platform can potentially be utilized for off-the-shelf treatment of many types of infectious diseases such as HPV, HIV, hepatitis, malaria and tuberculosis.
HerpV consists of recombinant human heat shock protein-70 complexed with 32 distinct 35-mer synthetic peptides from the HSV-2 proteome. This broad spectrum of herpes antigens is intended to allow for more accurate immune targeting and surveillance, reducing the likelihood of immune escape. Further, the diversity of antigens in HerpV
increases the chance of providing efficacy for a wide segment of the patient population.
About QS-21 Stimulon Adjuvant
QS-21 is a vaccine adjuvant designed to strengthen the body's immune response to a vaccine's antigen, thus making it more effective. QS-21 has become a critical component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to be essential for several investigational
therapeutic vaccines intended to treat cancer and degenerative disorders. Currently, QS-21 is being studied in clinical trials in approximately 15 vaccine indications, of which 1 Genital Herpes

[sdaktien]

Bis jetzt verdient Agenus kein Geld. Gibt es von dort irgendwelche Hinweise, wann es soweit sein soll?
Laut Analystenschäzungen (Quelle CNBC) sol sich der Verlust 2013 auch wieder ausweiten. Hast du eine Ahnung warum das so sein soll oder kann?

Nach dem Ausbruch im Frühjahr ist Agenus wieder in einem Abwärtstrend der von der 38er nach oben begrenzt wird (momentan bei ca. 5$). In den letzten Wochen ist auch das Handelsvolumen wieder leicht angestiegen. Zudem scheint auch dem Stochastik die Luft auszugehen. Nächste Unterstützung wäre die 200er, die bei ungefähr 4,2$ liegt.

[Shanghai2006]

Antwort auf Beitrag Nr.: 43.475.060 von sdaktien am 09.08.12 14:00:04

Die haben bisher nur ein Produkt bei dem Sie Geld von Glaxosmith erhalten.
Forschung kostet Geld, hoofe das noch ein paar Produkte gut entwickelt werden koennen. Die BIG Pharma ist ja immer an guten produkten interessiert. Muss halt alles noch gut durch die einzelenen Testphasen durchkommen.

High Risk Aktie.

[dottore]

Agenus ist für die nächste Zukunft sicher einer der Biotech-Werte mit dem größten Aufwärtspotential.
Die guten Meldungen reißen nicht ab. Die Übernahme der 4 Antibody AG war ein Geniestreich. Die langfristige Unterstützung und Zusammenarbeit mit GSK ist kein Geheimnis.
Und dann schaut euch die Pipeline an. Vier Präparate in Phase III, bzw. BLA.Filing für den MalariaImpfstoff.
http://www.swissbiotech.org/php5/aa2/index.php?1=1&id=504109

Bevor es losgeht, bin ich eingestiegen, beobachte schon eine Zeit lang, jetzt bekomme ich langsam Sorge, nicht mehr günstig rein zu kommen.

[dottore]

durch den gestrigen Kursknick bin ich insgesamt 5-6% im Minus. Das scheint dem schlechten Gesamtmarkt geschuldet zu sein.
Soll mir recht sein, weil ich (vorausgesetzt keine schlechten News) noch aufstocken möchte.

[dottore]

Kurs ist schon wieder oben. Heutige Meldung

2/13 07:17 AM
Agenus Completes Acquisition Of 4-Antibody

[dottore]

mit dem Aufstocken bin ich zu spät, aber mein Bauch will noch welche und deshalb habe ich gerade zu 4,08 nachgelegt.
Auf grund der weiter oben im Thread beschriebenen Fakten erhoffe ich mir eine ähnliche Kursentwicklung, wie sie bei Idera bereits eingetroffen ist.

[Gustl24]

Ich bin heut auch eingestiegen...seit Donnerstag auf dem Radar...keine Zeit gehabt zu handeln...
Dann noch blöderweise das Gap-close nicht abgewartet und heut zu 4,18$ gekauft...

Aber ich sehe hier mächtiges Potential...also hab ich's gemacht...aber mein Timing hier war ganz schlecht

[sufenta]

Antwort auf Beitrag Nr.: 46.515.185 von Gustl24 am 24.02.14 19:22:58

Auch seit heute rein zu 4,14.

Will auch noch nachladen.

Die Pipeline ist exzellent.

Gruss

[dottore]

Im chart über ein ganzes Jahr kann man sehen, dass um 4 $ plus minus 20 Cent ein kräftiger Boden - jetzt Widerstand - besteht.
Es kann also etwas dauern, bevor es nachhaltig weiter hoch geht, es kann sogar noch einmal bis 3,80 ungefähr runter gehen.

Bin mir nicht sicher, ob ich es mir insgeheim sogar wünsche (aber nur, wenn ich dann auch flüssig genug bin zum noch einmal nachladen)

Hoffe, dass nun endlich die Nachricht bei Intellipharma mit mehrfacher Zulassung für Generika kommt. Auch Biohero schreibt, die sei überfällig.
Dann schichte ich um!

[dottore]

in der ersten Handelshälfte ging es heute noch mal um die 4$-Marke. Das heißt wir haben intraday um die 10% gemacht.
Vielleicht noch etwas zu früh, aber ich glaube, dass es doch wieder aufwärts gehen wird und der Widerstand in einem kräftigen Rutsch genommen werden wird, wahrscheinlich noch diese Woche.

[Gustl24]

Antwort auf Beitrag Nr.: 46.522.789 von dottore am 25.02.14 20:25:49

Habe heute nochmals aufgestockt...nach eingehender Lektüre div. Quellen...u.a. einiger Artikel
auf Seeking Alpha sehe ich hier extremes Potential...insbesondere dass die Company im Editorial
von Neuro Oncology bereits genannt wird plus Pipeline plus Neuaquisition vor einigen Tagen...

We will see...der Kurs wird sowieso in USA gemacht...kann man ruhig ein bisschen träumen hier

[sufenta]

Antwort auf Beitrag Nr.: 46.523.599 von Gustl24 am 25.02.14 22:58:19

Ebenfalls (aufgestockt).

Und bei DER Volatilität (gekauft RT zu 4,74, paar min. später knapp über 4,50), mal eben 5% zuviel bezahlt. Bei > 10 in den nächsten Wochen/Monaten, aber wohl wurscht.

Gruss

[dottore]

Kauforder 16.36Uhr zu 4,60 immer noch nicht ausgeführt, obwohl der Kurs ständig zwischn 4,55 und 4,60 schwankt

[dottore]

immer noch nicht ausgeführt

[sufenta]

Antwort auf Beitrag Nr.: 46.529.127 von dottore am 26.02.14 18:03:33

Warte auch auf Verkauf Erba Diagnostics um Cytosorbents das mindestens 5. mal nachzukaufen.

Bin aber bei dieser scheissdreck comdreck: musst jedesmal anrufen.Eine order aufzugeben dauert dann in etwa 5-10min!!! Entweder funktioniert dies nicht oder jenes. oder das Systems muss gewechselt werden. Ich war so ein grosser Idiot zu dieses drecksbrocker gegangen zu sein. Im Vgl. zu cortalconsors sind die im Mittelalter. Diese Woche wird noch gekündigt.

Schau mal rein bei Cytososrbents und sag mir mal Deine Meinung. Ich denke, dass wir den Dollar noch dieses Jahr sehen werden.

Gruss

[Gustl24]

Bei 4,89$ mal Gewinne mitgenommen...18% in 2 Tagen inkl. Gebühren reichen mir...

In Celladon umgeschichtet...war ein Hammer IPO Biotech vor einigen Wochen, jetzt den Absacker unter 11$ zum Kauf genutzt ...auch hier wird der Kurs nur in USA gemacht-
Deshalb keine Werbung hier

[Gustl24]

Antwort auf Beitrag Nr.: 46.529.599 von Gustl24 am 26.02.14 19:05:44

Pfizer, Novartis und J&J sind übrigens Major Stockholder bei Celladon...das sagt wohl alles

Sorry Off Topic...jetzt wieder zu Agenus

[sufenta]

Antwort auf Beitrag Nr.: 46.529.623 von Gustl24 am 26.02.14 19:09:04

Hi,

ist doch ok, wenn auch off topic.

Da die Kurse in den USA gemacht werden, wie Du sagst, kann man sich doch hier durchaus tipps geben, hab ich oben doch auch gemacht.

Hab soeben Cytosorbents nachgekauft. Musste leider voll 0,33 zahlen!.

Schau mir jetzt mal Deine Celladon an.

Hast Du denn Agenus kein höheres Potential mehr gegeben, dass Du schon ausgestiegen bist?

Will unter 10 nicht geben.

[dottore]

hi, das hast du genau falsch verstanden. Ich bin nicht ausgestiegen. Ich bin bei ungefähr 3$ eingestiegen und habe bei 4,08 nachgelegt. Heute wollte ich unter 4,60 noch einmal nachlegen.Wurde leider nicht ausgeführt (waren nur Tax)

Wir stehen hier auch bei 5 oder 6 $ noch ziemlich am Anfang. Aber wenn man ein paar Stücke mehr hat, kann man traden mit einem Teil

[sufenta]

Antwort auf Beitrag Nr.: 46.529.623 von Gustl24 am 26.02.14 19:09:04

Celladon:

Studiendesign ist auf den ersten Blick gut: doppelblind, placebo-kontrolliert und mulizentrisch

n= ? Anzahl der Patienten?)

Und, Ergebnisse Anfang 2015 erwartet.

Dafür und nur für ein Produkt, mit knapp 200 Mio $ extremst ambitioniert bewertet.

Jedoch, bei Signifikanz: 10-bagger (mindestens), da akutem Herzversagen eigentlich nichts zur Verfügung steht an medikamentöser Therapie im Sinne eines bridgings oder zur Verbesserung des cardialen Remodellings.

Muss erst überlegen, wo ich raus und umschichten kann. Eine kleine Spekulation allemal wert. Danke für den Tipp.

Und wie wir die Amis kennen, werden sie das Ding auch noch auf 50 pushen! Also müssen wir noch schleunigst rein. (man überlege sich nur, wieviel Organovo bwertet wird: wollen ja Organe drucken, meine die MK sind um die 700 mio $)

Gruss

[sufenta]

Antwort auf Beitrag Nr.: 46.529.747 von dottore am 26.02.14 19:25:55

hi dottore,

war auf Gustl bezogen mein Beitrag.

[dottore]

hab mal ein wenig zu Celladon geschaut. Haben wohl gerade ihr Börsendebüt gefeiert. Der Kursanstieg ist schon ziemlich heftig, das Ende der PhaseII Studie erst in 2015.
Ich glaub da ist sehr viel Biotec-Hype und Erstnotizwohlwollen dabei.

Die kann man sich später auch noch kaufen.

Cytosorbents habe ich noch zu "Brauchgeld"s Zeiten hier kennengelernt. Der hatte einen Thread 2009 eröffnet.
Hat mich damals nicht überzeugt. Der Langzeitchart zeigt, dass die schon 2 mal 2009 und 2011 gewaltig hochgezockt wurde.

Da sind wir hier auf wirklich seriösem Boden und mit 100% Kurssteigerung noch vor dem Sommer, so jedenfalls mein Ziel.

Übrigens mit Schwankungen zum Traden.Hätte heute gern noch welche zu 4,60 abgesaugt ....

[Gustl24]

Zitat von sufenta: Hi,

ist doch ok, wenn auch off topic.

Da die Kurse in den USA gemacht werden, wie Du sagst, kann man sich doch hier durchaus tipps geben, hab ich oben doch auch gemacht.

Hab soeben Cytosorbents nachgekauft. Musste leider voll 0,33 zahlen!.

Schau mir jetzt mal Deine Celladon an.

Hast Du denn Agenus kein höheres Potential mehr gegeben, dass Du schon ausgestiegen bist?

Will unter 10 nicht geben.

Nach 15 Jahren Biotech hab ich einfach gelernt Gewinne mitzunehmen...aber ich traue Agenus durchaus weiteres
Potential zu...ich gehöre nicht zu den Leuten welche nach dem Ausstieg eine Aktie schlechtreden...ich hoffe ihr habt hier noch Fette Gewinne!!
Warum bin ich ausgestiegen: Agenus ist jetzt nach der KE Anfang Februar fast 100% über dem KE Preis...da werde ich dann vorsichtig nach wenigen Tagen bzw. Wochen...

Da Celladon nach meinem Einkauf heut schon 8% Intraday über meinem EK steht kann ich mich nicht beklagen-dann müssten wir hier schon bei 5,30$ um pari zu sein...so will ich mich nicht beklagen

[Gustl24]

Antwort auf Beitrag Nr.: 46.530.407 von dottore am 26.02.14 21:04:13

Brauchgeld war aber schon ein gaaaanz Guter...der hatte auch wirklich Fachwissen...
Celladon ist gestiegen weil Sie nach wenigen Tagen schon wieder einen Deal mit Servier gemeldet hatten...
Nix Biotechhype...die sind extrem vernetzt mit den BigPlayern...deshalb mein Kauf!!!

Sorry jetzt aber genug Off Topic...ich gönne euch gern die 7-8 Euro hier, wenns denn so kommen sollte!

[christianka]

Agenus Inc. director declared owning 996,088 shares of Agenus Inc.
;-)

[dottore]

ich denke, dass Brauchgeld sehr fleißig und Fachkundig war. Leider hatte er eine ziemlich überhebliche Art gehabt und auch eine ganze Reihe Schrott promoted, neben sehr vielen richtig guten.

Bin mir nicht sicher, dachte Biohero ist sein jetziger Nick. Biohero stellt hier auch viele interessante Threads rein und wirkt nicht so arrogant.

Ich erwarte auch, dass es einen Kursrücksetzer in Bälde geben wird. Aber aufgrund der Verpartnerung und mehrere Produkte in der Pipe gehe ich davon aus, dass sie dann rasch weiter steigen wird. Ich hoffe auf einen ähnlichen Kursverlauf wie bei Idera in den letzten Monaten.

[Gustl24]

Antwort auf Beitrag Nr.: 46.534.213 von dottore am 27.02.14 13:33:18

Hast du recht- Brauchgeld war ein K..tzbrocken...aber ein paar Tipps in 2008 waren echt Hammer ...

Biotech ist schon ein Wahnsinnshype zur Zeit wieder...ich halte aus lehrreicher Erfahrung nicht sehr lange...Celladon
auch bereits nach 24 h wieder versilbert mit 17% inkl. Gebühren...ich switche sehr viel zur Zeit....vielleicht sollten wir mal Tipps enger austauschen- man kann natürlich auch über BM gehen wenn gewünscht...ich mach mich dann mal wieder auf die Suche
nach einem neuen Pferdchen

[sufenta]

Antwort auf Beitrag Nr.: 46.536.943 von Gustl24 am 27.02.14 19:23:38

Hi Gustl,

Bei einem nicht so frequentiertem Thread können wir die Tips sehr gerne auch u.a. hier austauschen.

Natürlich auch per BM.

Meine Tips momentan:

Cytosorbents hatte ich oben schon genannt.

Ansonsten bin ich bei Cardiome mit > 10% Deporanteil dabei. Bei ariva gibt es einen Thread, wo wir alle unsere Tips mittlerweile austauschen. User Chali und ich haben dort damit angefangen und es funktioniert.Dort schreib ich unter dem Namen Eco1.

Gestern bin ich mit einer kleinen Posi in GV (Goldfiel Corp., nix mit God zu tun) eingestiegen. War schon mal von 2,30 bis knapp > 4 letztes Jahr dort mit dabei.

Gestern auch in Dara Biosc. ebenfalls rein. Sind aber immer nur Mini-Posis.

Sonst hab ich Dir eben Grüsse im MY (China Ming Wind) Thread geschrieben.

Achja, ganz vergessen: bin mit 10% Depotanteil ebenfalls in Catalyst Pharma zu 3,0 und 1,99 drin. Hier will ich unter 6 nicht verkaufen. Könnt aber ein paar Monate dauern.

Elite Pharm. werd ich wohl ein paar Stücke nachlegen.

Celladon werde ich wohl versuchen bis 20 zu halten: SL 9,XX

[sufenta]

Antwort auf Beitrag Nr.: 46.537.387 von sufenta am 27.02.14 20:37:56

Hab gerade die Nanorepro entdeckt.

HIV-Test-Zulassung?!

Könnten schnelle 20-30% werden.

Meinung?

[dottore]

wir haben hier auf wallstreet-online auch einen extrathread für Biotec-Investideen.
Wäre mir ganz recht, wenn hier nicht alle möglichen anderen Werte kommentiert werden.
Mal ein einzelner Hinweis auf gutes Potential ist immer willkommen, dann lieber BM.

Hier bleiben wir lieber bei AGENUS

Im Übrigen im späten Handel doch noch mal ins Minus gerutscht. Hätte ich nicht mehr mit gerechnet.
Da ich von weiterem Kurspotential ausgehe, werde ich eine kleine Abstauberorder aufgeben. Vielleicht krieg ich doch noch welche zu 4,60 und wenn nicht, steigt eben der Kurs der bereits im Besitz befindlichen Stücke.

[sufenta]

Antwort auf Beitrag Nr.: 46.540.837 von dottore am 28.02.14 12:00:33

Hi doc,

könntest Du den link für die Biotec-Invetsideen hier reinstellen?

Thanks,

s.

[dottore]

Zitat von sufenta: Hi doc,

könntest Du den link für die Biotec-Invetsideen hier reinstellen?

Thanks,

s.

klar

http://www.wallstreet-online.de/diskussion/1172162-1-10/deut…

http://www.wallstreet-online.de/diskussion/1173523-1-10/biot…

http://www.wallstreet-online.de/forum/21-51-100/biotech

meine Biotech Favoriten sind derzeit
Genvec, Idera, Elite Pharma, Agenus

[Randfontein]

Die Agenus-Zahlen scheinen ganz gut anzukommen.
Immerhin zuckt diese meine Neuerwerbung heute wesentlich mehr als meine etwas eingeschlafene Ariad...

Viel Glück uns allen, äh, uns paar Hanseln oder so...

[dottore]

ja, wir waren ja schon wieder bei 5,18$. Die 10% um die 5$-Marke erinnert an die Bewegungen eines Elektrons um den Atomkern.

Bin gespannt, wann es wieder nach oben schiessen wird. Hoffentlich nicht gleichzeitig mit den anderen. Dann kann man schön hin und her umschichten.

Das bringt bei meinen Größenordnungen zwar immer nur ein paar hundert Dollar, aber die gibt es ja zusätzlich

[Randfontein]

Okay, dottore "immer nur ein paar hundert Dollar"...
Damit sollten wir die Kassierinnen beim Aldi grüßen, die Pfleger im Altenheim etc.

Ich seh' das ähnlich:
ab und zu einen richtig steilen Langläufer und für die laufenden Ausgaben die trading-Gewinne.
Mensch, uns geht's verdammt gut, selbst wenn nicht immer alles klappt.
Nur so zwischendurch für die Bodenhaftung...

Schönen Abend!

[dottore]

ja, volle Zustimmung. Mit Biotecs läuft es die letzten Monate sensationell gut bei mir.

Man kann nicht überall dabei sein und nicht jedes Mal Dips und Hype abpassen.

[sufenta]

Antwort auf Beitrag Nr.: 46.570.225 von dottore am 05.03.14 17:53:10

So ist es.

Wollte gerade bei comdreck Tekmira kaufen: nach mehrfachen Versuchen,nach Verbindung mit anderer Abteilung teilt man mir wortwörtlich mit:

UNSER (comdreck nennt sich selbst ein Broker) Broker kann diese Aktie nicht kaufen, sie können sie nicht ordern.

Diese elende comdreck ist eine absolute Witzscheiss-Bank kann ich Euch nur sagen!

Hatte keine Zeit zu kündigen. Aber morgen ist es definitiv so weit.

Agenus KZ 10! Darunter kein Verkauf!

[sufenta]

Antwort auf Beitrag Nr.: 46.570.509 von sufenta am 05.03.14 18:39:33

Achja, vor lauter Wut vergessen:

Benitec wollt ich an der Nasdaq/OTC kaufen: Geht auch nicht. Können nur in Sydney kaufen, weiss aber nicht, ob die noch auf haben. Aktueller Kurs ist 1,82.

Ich hab nachgeschaut und mitgeteilt, dass Sydney in der Tat schon zu hat. Und der Kurs nicht 1,82 ist, das ist der Nasdaq-Kurs, sondern der SK in Sydney war 2,01 A$.

Man man man.

Tekmira wollt ich bei 21,nochwas kaufen, jtzt bei 23, nochmas.

Comscheissdreck. Sorry Leute! musste ich aber loswerden, die nennen sich ja Deutschlands bester Broker, aber ihr Broker kann eine liquide Nasdaq-Aktie nicht ordern! Witz hoch drei

[dottore]

Ende der Konsolidierung! Intraday vom Tief bei 4,08 gewaltig hoch gekommen bis 4,35. Das sind etwa 6%. Nun kann es wieder hoch gehen. Wenn schon der Teilausstieg beim letzten Hype verpasst wurde, klappts vielleicht das kommende Mal.
Kursziel noch nicht in Sicht!

[dottore]

Aus der Schockmeldung
".... Agenus' QS-21 Stimulon adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen and includes several candidates in Phase 3 trials. Among Agenus and its partners, 23 programs are in clinical development...."

Da sollte ein Kursabschlag nicht gleich 18% betragen, wie es hier der Fall Vorbörslich ist.

Außerdem will GSK die Studie weiter laufen lassen. Da die Studien verpartnert sind, wird auch Geld fliessen. Nur spätere Zahlungen werden unwahrscheinlicher und nur für diesen einen Kandidaten. Aber es kommt natürlich die Sorge auf, ob das Nichterreichen der Ziele eben auch für die anderen Kandidaten zu erwarten sein wird. Und sollte das auch für eine der anderen Studien zutreffen, dann sieht es schlecht um Agenus aus.
Für den Moment erscheint mir der Abschlag um 18% übertrieben.
http://www.nasdaq.com/press-release/gsks-mage-a3-cancer-immu…

[dottore]

jetzt sind es noch gute 11% Abschlag. Sehr ärgerlich, weil ein Kursanstieg in absehbarer Zeit wohl nicht zu erwarten sein wird (außer technischer Reaktion)

[Randfontein]

Na, immerhin streckt Agenus nach den Meldungen über mögliche Milestone-Zahlungen mal wieder den Kopf 'raus.
Gelegentliches Abtauchen muss bei Biotechs ja nicht viel heißen.
Okay, noch ist Agenus "under the radar", aber gerade das könnte es irgendwann zur "Rakeeete" machen.
(Was ich brauche, wie ein Loch im Kopf, da ich nicht an Börsen-Raketen glaube - aber das ist wieder 'ne andere Story)

[Randfontein]

Jetzt aber!
Im pre-market 40% im Plus wegen Vereinbarung mit Incyte:
http://investor.agenusbio.com/press-release/incyte-and-agenu…

[Shanghai2006]

Take Long View

It looks like Agenus is in decent financial shape. In September, the company raised $78 million through a non-dilutive sale of its royalty rights on future sales of GlaxoSmithKline's (NYSE:GSK) shingles and malaria vaccine products that use Agenus' QS-21 adjuvant technology. There could be additional upside from that transaction, too, as Agenus could be entitled to another $15 million from the deal if GlaxoSmithKline's shingles vaccine wins regulatory approval before June 30, 2018. The two companies plan to work toward a regulatory filing in the second half of the year.

When added to the proceeds from Agenus' common offering in May, the company ended the year with more than $171 million in cash on its books, which it believes should be enough to run itself through the first half of next year. That number could stretch even further if GlaxoSmithKline can successfully commercialized its shingles vaccine.

Looking ahead, the company has a busy year planned as it has announced plans to push several of its preclinical compounds into trials throughout the year, which includes two of its checkpoint modulator antibodies, AGEN1884 and INCAGN1876.

All in all, Agenus' stock offers investors an interesting pipeline that holds a lot of potential, but like any other money-losing biotech, the company's stock isn't for the faint of heart.

[Shanghai2006]

So what: Agenus exited the first quarter with $148.2 million in cash, cash equivalents, and short-term investments. While that may sound like a fair sum for a clinical-stage biotech, it's important to bear in mind that Agenus' net loss ballooned to roughly $32 million in the first quarter (up from $18.8 million a year ago), and its cash needs are only expected to increase as its clinical activities expand. The point is that Agenus may have to consider a secondary share offering within the next six to 12 months in order to cover its rising clinical expenses, putting further pressure on its share price during an already volatile period for developmental biotechs.

Now what: Agenus' future more or less hinges on its checkpoint inhibitor and modulator platform -- even though it sports some other intriguing clinical assets in the areas of cancer vaccines and saponin-based vaccine adjuvants. After all, Incyte has already made a $35 million equity investment in Agenus, perhaps setting the stage for a buyout later on, especially if the ongoing clinical work for the anti-GITR agonist antibody INCAGN1876 goes according to plan.

Putting the buyout scenario aside, though, the main question is whether Agenus' cancer fighting portfolio of checkpoint inhibitors offers a compelling value proposition going forward. Although there is a fair amount of overlap with both Merck and Pfizer's respective checkpoint inhibitor portfolios, I still think there's enough there to warrant a substantially higher market cap, even if Agenus never produces a franchise level drug. Of course, Agenus' cash burn is a real concern, but that's not an unusual risk factor for a developmental-stage biotech, and it can ultimately be overcome by steady progress on the clinical front.

[Shanghai2006]

Shares of Agenus Inc. (NASDAQ:AGEN) have received a consensus recommendation of “Buy” from the nine research firms that are covering the firm. One analyst has rated the stock with a hold rating and eight have issued a buy rating on the company. The average 1 year target price among brokerages that have updated their coverage on the stock in the last year is $12.60.

Several research firms have issued reports on AGEN. HC Wainwright reiterated a “buy” rating on shares of Agenus in a research report on Saturday, April 30th. Maxim Group reiterated a “buy” rating on shares of Agenus in a research report on Wednesday, April 27th. Finally, Zacks Investment Research upgraded Agenus from a “sell” rating to a “hold” rating in a research report on Tuesday.

In related news, CEO Garo H. Armen bought 100,000 shares of Agenus stock in a transaction that occurred on Monday, May 9th. The shares were purchased at an average price of $3.18 per share, with a total value of $318,000.00. Following the purchase, the chief executive officer now owns 1,346,026 shares in the company, valued at $4,280,362.68. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is available at this hyperlink.








Shares of Agenus opened at 4.69 on Tuesday. The company has a 50 day moving average price of $4.08 and a 200 day moving average price of $3.78. The firm’s market cap is $407.48 million. Agenus has a 12-month low of $2.61 and a 12-month high of $9.64.

Agenus last issued its quarterly earnings results on Thursday, April 28th. The company reported ($0.37) earnings per share (EPS) for the quarter, missing the Thomson Reuters’ consensus estimate of ($0.23) by $0.14. On average, analysts forecast that Agenus will post ($1.41) earnings per share for the current fiscal year.

[Shanghai2006]

Shares of Agenus Inc. (NASDAQ:AGEN) have received a consensus recommendation of “Buy” from the nine research firms that are covering the firm. One analyst has rated the stock with a hold rating and eight have issued a buy rating on the company. The average 1 year target price among brokerages that have updated their coverage on the stock in the last year is $12.60.

Several research firms have issued reports on AGEN. HC Wainwright reiterated a “buy” rating on shares of Agenus in a research report on Saturday, April 30th. Maxim Group reiterated a “buy” rating on shares of Agenus in a research report on Wednesday, April 27th. Finally, Zacks Investment Research upgraded Agenus from a “sell” rating to a “hold” rating in a research report on Tuesday.

In related news, CEO Garo H. Armen bought 100,000 shares of Agenus stock in a transaction that occurred on Monday, May 9th. The shares were purchased at an average price of $3.18 per share, with a total value of $318,000.00. Following the purchase, the chief executive officer now owns 1,346,026 shares in the company, valued at $4,280,362.68. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is available at this hyperlink.






News 6.July 2016

Shares of Agenus opened at 4.69 on Tuesday. The company has a 50 day moving average price of $4.08 and a 200 day moving average price of $3.78. The firm’s market cap is $407.48 million. Agenus has a 12-month low of $2.61 and a 12-month high of $9.64.

Agenus last issued its quarterly earnings results on Thursday, April 28th. The company reported ($0.37) earnings per share (EPS) for the quarter, missing the Thomson Reuters’ consensus estimate of ($0.23) by $0.14. On average, analysts forecast that Agenus will post ($1.41) earnings per share for the current fiscal year.

[Shanghai2006]

News from 08. July 2016

According to Zacks, “Agenus has several collaboration agreements, which not only validate its technology platforms but also provide funds. It received a major boost when the FDA cleared its IND application for AGEN1884 and a second CPM antibody, for which it has a partnership with Incyte. We are encouraged by the company’s efforts in developing Prophage Series vaccine for glioblastoma multiforme. However, Agenus is heavily dependent on its partners for pipeline development. Agenus has only a few candidates in mid-stage of development including Prophage Series vaccine and a number of QS-21 Stimulon-containing vaccine candidates. Any unfavorable outcome from the studies may affect shares adversely.”

Several other analysts also recently commented on the company. HC Wainwright reissued a buy rating and issued a $10.00 price objective on shares of Agenus in a research note on Monday, March 7th. Maxim Group reissued a buy rating and issued a $7.00 price objective on shares of Agenus in a research note on Friday, June 10th. JMP Securities lowered their price objective on Agenus from $17.00 to $15.00 and set a market outperform rating for the company in a research note on Wednesday, March 9th. Finally, JPMorgan Chase & Co. lowered their price objective on Agenus from $17.00 to $15.00 and set a market outperform rating for the company in a research note on Wednesday, March 9th. One equities research analyst has rated the stock with a hold rating and eight have issued a buy rating to the company. Agenus presently has a consensus rating of Buy and an average price target of $10.47.

In other news, CEO Garo H. Armen acquired 100,000 shares of Agenus stock in a transaction on Monday, May 9th. The stock was acquired at an average cost of $3.18 per share, with a total value of $318,000.00. Following the completion of the acquisition, the chief executive officer now owns 1,346,026 shares in the company, valued at $4,280,362.68. The acquisition was disclosed in a legal filing with the Securities & Exchange Commission, which is available through this link.

Several large investors recently bought and sold shares of AGEN. Wells Fargo & Company MN increased its stake in Agenus by 177.2% in the fourth quarter. Wells Fargo & Company MN now owns 332,554 shares of the company’s stock valued at $1,510,000 after buying an additional 212,599 shares in the last quarter. BlackRock Institutional Trust Company N.A. increased its stake in Agenus by 1.0% in the first quarter. BlackRock Institutional Trust Company N.A. now owns 1,778,629 shares of the company’s stock valued at $7,399,000 after buying an additional 17,006 shares in the last quarter. Squarepoint Ops LLC increased its stake in Agenus by 19.1% in the first quarter. Squarepoint Ops LLC now owns 76,700 shares of the company’s stock valued at $319,000 after buying an additional 12,300 shares in the last quarter. Goldman Sachs Group Inc. increased its stake in Agenus by 167.9% in the first quarter. Goldman Sachs Group Inc. now owns 49,483 shares of the company’s stock valued at $206,000 after buying an additional 31,014 shares in the last quarter. Finally, RTW Investments LLC increased its stake in Agenus by 11.1% in the first quarter. RTW Investments LLC now owns 2,414,524 shares of the company’s stock valued at $10,044,000 after buying an additional 241,257 shares in the last quarter.

[Shanghai2006]

http://finance.yahoo.com/news/agenus-agen-reports-narrower-e…


Agenus Inc. AGEN is a Lexington, MA-based development-stage company focused on the discovery and development of checkpoint modulators, vaccines and adjuvants for the treatment of cancer.

Agenus’ revenues consist of fees earned under license agreements with its partners. With no approved products in its portfolio, investor focus should remain on the company’s pipeline updates.

Agenus’ track record has been disappointing so far. The company has missed estimates in all of the last four quarters, with an average surprise of -54.65%.

Currently, Agenus has a Zacks Rank #3 (Hold), but that could definitely change following the company’s earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below:

Earnings: Agenus reported narrower-than-expected loss in the second quarter of 2016. Our consensus called for a loss of 34 cents per share, while the company reported a loss of 24 cents.

Revenue: Revenues also surpassed expectations. Agenus posted revenues of $6.6 million, compared to our consensus estimate of $6 million.

Key Stats: Agenus’ efforts for the development of its pipeline are pleasing. Agenus received a major boost when the FDA cleared its Investigational New Drug (IND) application for AGEN1884 and INCAGN01876. A phase I study on AGEN1884 and a phase I/II study on INCAGN01876 has been initiated to treat solid tumors. The selection of Agenus’ lead candidate as well as several backup antibodies by Merck for an undisclosed checkpoint target led the company to receive a milestone payment of $2 million under the terms of the agreement.

[Shanghai2006]

http://www.foxbusiness.com/markets/2016/08/18/2-cancer-thera…

18.August 2016


2 Cancer Therapy Stocks That Are Ridiculously Cheap Right Now

The cancer drug market is already valued at over $100 billion but is still growing at one of the fastest compound annual growth rates in entire the pharmaceutical industry. The underlying reason for this surge in oncology drug sales is the emergence of breakthrough products like Bristol-Myers Squibb's checkpoint inhibitor Opdivo, along with the seemingly never-ending rise in cancer incidence rates across the globe.

That said, the market hasn't exactly been applying rich premiums to the share prices of most cancer therapy stocks of late, perhaps making some of these stocks great bargains for patient investors. Armed with this insight, here is a deeper look at two cancer stocks that are arguably ridiculously cheap based on the long-term prospects of their respective clinical pipelines.

Big pharma is starting to take interest in this tiny immuno-oncology company

Agenus (NASDAQ: AGEN) is a tiny cancer immunotherapy company that sports an immense pipeline of checkpoint inhibitors and modulators targeting a rich array of receptors with known anti-tumor properties. As a result, the company has been able to attract partnerships with both Incyte Corp. and Merck & Co. to help advance its anti-cancer checkpoint inhibitor platform.

The Incyte partnership has already led to the launch of a combined phase 1/2 clinical trial for the anti-GITR checkpoint antibody INCAGN1876in solid tumors, and the two companies are also reportedly close to initiating another early stage trial for anOX40 agonist antibody sometime in the back half of 2016.

The Merck collaboration is reportedly starting to pick up steam as well. Agenus noted in its second-quarter earnings call, for instance, that Merck has now selected a lead product candidate to advance into preclinical studies, triggering a $2 million milestone payment. The underwhelming part, though, is that Merck hasn't revealed much about the details of this collaboration with Agenus, making it difficult to place a long-term value on this joint effort.

Apart from its collaborations with Incyte and Merck, Agenus is apparently also listening to offers to license out its proprietaryCTLA-4 antibody that's currently in a phase 1 stage for advanced solid tumors. While the likelihood of yet another partnership is impossible to handicap at this point, the bigger issue to keep in mind is that the company's checkpoint inhibitor platform has definitely caught of the eye of big pharma at this stage, perhaps leading to even more deals or an outright buyout offer down the line.

Buyout or not, this small-cap biotech is on track to produce a treasure trove of clinical updates starting next year, giving investors ample reasons to dig deeper. The key point is that Agenus' market cap of only $525 million at the moment would seem to make it dirt cheap, given that its checkpoint inhibitor platform has the potential to generate billions in revenues in the not-so-distant future.

Don't sleep on this hidden gem

Bellicum Pharmaceuticals (NASDAQ: BLCM) is an up-and-coming player in the hotly contested adoptive cell therapy space. Although Bellicum is trailing the industry leaders Kite Pharma and Juno Therapeuticsin the race to bring one of these novel cell therapies to market, the company does sport a potential game changer with its proprietary Chemical Induction of Dimerization (CID) technology that's designed to make adoptive T cell therapies safer and more potent. Kite and Juno, after all, have both run into trouble with their initial product candidates from a safety standpoint, casting doubt on their ability to move into more profitable, earlier lines of treatment.

Image Source: Getty Images

In a promising turn of events, Bellicum recently announced that it may even be able to leapfrog Kite and Juno -- at least in Europe. Specifically, the Houston-based drugmaker said that European authorities are open to considering a regulatory filing for the company's lead product candidate,BPX-501,in pediatric patients with leukemias, lymphomas, and rare inherited blood diseases.

The somewhat unusual part is that an approval would be based on the dual phase 1/2 study known as the BP-004 trial. In short, European regulators are apparently willing to forgo a large, randomized trial if BPX-501 continues to shine in its ongoing study, presumably due to the complete lack of treatments for these rare but deadly blood disorders.

In addition to BPX-501, Bellicum is also close to launching early stage clinical trials for its high-affinity T cell receptor (BPX-701) and GoCAR-T (BPX-601)product candidates. According to the company,BPX-701 will initially target blood-based disorders such as refractory or relapsed acute myeloid leukemia and myelodysplastic syndromes. And BPX-601 is set to enter a phase 1 study as a possible treatment fornon-resectable pancreatic cancer.

Although Bellicum's cell-based platform has been progressing at breakneck speed lately, the market apparently hasn't taken notice. Bellicum's market cap of around $508 million, after all, is just a small fraction of the multi-billion dollar valuations of its lead competitors Kite and Juno.

To be fair, Kite and Juno's far higher market caps are partly the result of major partnering deals with bigger biotechs. But that fact doesn't totally explain Bellicum's comparatively meager valuation, especially since the biotech is pursuing a handful of therapies with blockbuster potential, and its CID platform could become the gold standard for adoptive cell therapies in general.

Time to buy?

Clinical-stage biotechs are always a high-risk investment. That being said, Agenus and Bellicum are both in the process of building out diverse clinical pipelines aimed at treating several high-value conditions. So, while undoubtedly risky, these two biotechs do offer investors some insurance in the event of a clinical or regulatory setback in the near term. And that's perhaps the main reason that these two stocks might be worth buying ahead of their upcoming catalysts. After all, it's not particularly common for small-cap cancer therapy stocks to sport multiple blockbuster product candidates.

[Shanghai2006]

Agenus pushed the right buttons with its first-quarter earnings report. The company reported a $124 million cash cushion at the end of March, which was $48 million more than it had at the end of 2016. The infusion came from Incyte, in return for global rights to develop and commercialize two programs. 

Agenus also unveiled an immune-oncology cell-therapy discovery program that it had apparently been working on for the last year-and-a-half. Although the company's market cap is only about $396 million at recent prices, it plans to spin off the surprise cell-therapy unit into a separate company to be majority owned by Agenus and funded from outside sources.

Now what
The company finished the first quarter on pace to lose about $68.4 million this year. With Incyte taking on a bigger load, the company expects to burn through $70 million less during the next year-and-a-half. 
With a thicker cash cushion, the company will have more breathing room to develop a PD-1 checkpoint inhibitor that it recently advanced into a mid-stage clinical trial. That cash cushion might come in handy because results from the study aren't expected until 2019.
In the meantime, investors will want to keep their eyes peeled for approval of a malaria vaccine that contains Agenus' vaccine booster under regulatory review in several large markets. If given widely expected green lights, Agenus will receive single-digit royalties from GlaxoSmithKline that could slow the company's cash-burn rate even further.

[Shanghai2006]

https://seekingalpha.com/article/4070756-incyte-120-buy-rang…

This is a partner of Agenus mentioned in the Beitrag Nr. 62 (Incyte).

[Shanghai2006]

Agenus, Inc. has a fundamental score of 21 and has a relative valuation of NEUTRAL.

http://www.capitalcube.com/blog/index.php/agenus-inc-value-a…

[Shanghai2006]

May 22, 2017 /PRNewswire/ -- Agenus Inc. (AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, today announced that an abstract on its anti-CTLA-4 antibody, AGEN1884 was accepted for poster presentation. The American Society of Clinical Oncology (ASCO) 2017 Annual Meeting will be held in Chicago, IL from June 2-6, 2017.

Safety, pharmacokinetic (PK) and pharmacodynamic (PD) readouts will be presented in patients with advanced and refractory malignancies. Early hints of efficacy will also be discussed.
Preclinical data presented at AACR in April indicated an additive pharmacodynamic effect in primate models when Agenus' antibodies targeting CTLA-4 and PD-1 were co-administered. This, along with our clinical data, sets the stage for the Company's plans to combine these two molecules in a Phase 1b study in the second half of this year.
The Company is also developing a next generation antibody targeting CTLA-4 as part of its innovative discovery pipeline.  This novel candidate exploits a distinct mechanism of CTLA-4 antagonism. It exhibits single agent potential and also combines effectively with Agenus' PD-1 antagonist, AGEN2034.
Poster Details
Poster title: Phase 1 open-label, multiple ascending dose trial of AGEN1884, an anti-CTLA-4 monoclonal antibody, in advanced solid malignancies.
Abstract number: #3075
Session title: Developmental Therapeutics - Immunotherapy
Session date and time: Monday June 5, 2017; 8:00 am – 11:30 am
The poster will become available on the Company's website at http://www.agenusbio.com/technology/publications/ following the poster session.
AGEN1884 was developed under a Collaborative Research and Development Agreement between Ludwig Cancer Research, 4-Antibody AG and Recepta Biopharma S.A. AGEN1884 is partnered with Recepta Biopharma S.A. for certain South American rights.

https://finance.yahoo.com/news/agenus-present-safety-results…

[Shanghai2006]

Interessting link for weekly upate on patents

http://stks.freshpatents.com/Agenus-Inc-nm1.php

[Shanghai2006]

Agenus to Participate at Two Upcoming Conferences in New York City: Jefferies Healthcare and JMP Securities Life Sciences

LEXINGTON, Mass., June 1, 2017 /PRNewswire/ -- Agenus Inc. (AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, today announced that the Company will present at the following conferences to be held in New York City, USA:
•The 2017 Jefferies Healthcare Conference:
• Jennifer Buell, Ph.D., Vice President of Research and External Affairs will present on Tuesday, June 6th at 10:30 a.m. EST.

•The 2017 JMP Securities Life Sciences Conference:
• Jean-Marie Cuillerot, M.D., Chief Medical Officer will participate in a panel session titled "Immuno-oncology: Checkpoints as Targets" on Wednesday, June 21st at 9 a.m. EST.

Webcast Information
The live and archived webcast of the Jefferies presentation will be accessible from the Company's website at www.agenusbio.com/webcast. Please log in approximately 5-10 minutes before the event to ensure a timely connection. A replay will be available on the Company's website approximately two hours after the call and will remain available for 90 days.

https://finance.yahoo.com/news/agenus-participate-two-upcomi…

[Shanghai2006]

LEXINGTON, Mass., June 5, 2017 /PRNewswire/ -- Agenus Inc. (AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, today announced the results from an ongoing Phase 1 dose-escalation trial for its anti-CTLA-4 antibody, AGEN1884, in patients with advanced solid malignancies. The results were presented during a poster session at the 2017 American Society of Clinical Oncology (ASCO) held in Chicago, IL.

"We continue to advance our anti-CTLA-4 antibody trial, the antibody is well tolerated and shows early signs of efficacy, with a partial response observed in an individual patient," commented Jean-Marie Cuillerot, M.D., Chief Medical Officer. "A robust safety and tolerability profile and suggestion of clinical activity are consistent with our plans to combine this molecule with our anti-PD-1 antibody in the coming months."
Interim analysis of data collected as of May 16th, 2017 for 16 subjects, who have exhausted all standard of care options, demonstrated an acceptable safety and tolerability profile for AGEN1884 at the 0.1, 0.3, 1 and 3 mg/kg dose levels. A partial response was observed for a patient with angiosarcoma at week 33, with a 92% reduction in tumor volume upon treatment with 0.1 mg/kg of AGEN1884. While symptoms associated with immune-related adverse events were present, there were no dose-limiting toxicities reported to date.
AGEN1884 was developed under a Collaborative Research and Development Agreement between Ludwig Cancer Research, 4-Antibody AG and Recepta Biopharma S.A. AGEN1884 is partnered with Recepta Biopharma S.A. for certain South American rights.

https://finance.yahoo.com/news/agenus-anti-ctla-4-antibody-1…

[Shanghai2006]

Zacks Equity Research

It has been about a month since the last earnings report for Agenus Inc. AGEN. Shares have lost about 15.7% in that time frame, underperforming the market.
Will the recent negative trend continue leading up to the stock's next earnings release, or is it due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers.
Agenus Reports Narrower-than-Expected Loss in Q1
Agenus reported first-quarter 2017 loss of $0.18 per share (including non-cash expenses), narrower than the Zacks Consensus Estimate of a loss of $0.32 and the year-ago loss of $0.37. The decline was due to the accelerated milestone payment received from Incyte Corporation.
Revenues were $26.96 million and surpassed the Zacks Consensus Estimate of $5 million. Revenues were considerably up from $5.96 million in the year-ago quarter.
Quarterly Highlights
Agenus' first-quarter research and development (R&D) expenses were up 30.4% to $32.6 million. But general and administrative expenses were down 15.8% to $7.8 million.
Pipeline Update
Agenus is progressing well with the candidates in its pipeline. Currently, the company is evaluating AGEN1884 in a phase I study. It expects to report early safety and efficacy data on AGEN1884 at the upcoming ASCO conference in 2017.
Additionally, the company is evaluating INCAGN01876 in a phase I study for the treatment of solid tumors.
Notably, GlaxoSmithKline filed for regulatory approval of Shingrix vaccine which contains Agenus' QS-21 Stimulon. In fact, GSK’s shingles has been filed for regulatory approval in the US, Canada, the EU and also in Japan. The final position of the agency is expected in the second part of this year.
The company plans to initiate studies on anti-PD-1 antagonist AGEN2034 in the first half of 2017.  In addition, Agenus looks ahead to begin combination studies on AGEN2034 and AGEN1884 in the second half of the year. Already, it has initiated phase I trial for AutoSynVax in Apr 2017 and completed enrolment as well.  
How Have Estimates Been Moving Since Then?
Analysts were quiet during the last one month period as none of them issued any earnings estimate revisions.

VGM Scores
At this time, Agenus' stock has an average Growth Score of 'C', though it is lagging a bit on the momentum front with a 'D'. Charting a somewhat similar path, the stock was allocated a grade of 'F' on the value side, putting it in the lowest quintile for this investment strategy.
Overall, the stock has an aggregate VGM Score of 'F'. If you aren't focused on one strategy, this score is the one you should be interested in.
The company's stock is suitable solely for growth based on our styles scores.

https://finance.yahoo.com/news/agenus-agen-down-15-7-0723075…

[Shanghai2006]

An underappreciated opportunity in immuno-oncology
George Budwell (Agenus): Agenus is a small-cap immuno-oncology company shrouded in doubt, and for good reason. Like Exelixis before its breakthrough in advanced kidney cancer with Cabometyx, Agenus is currently treading water in terms of its value proposition to investors. Despite having multiple checkpoint modulators under development in both partnered and unpartnered trials, for instance, the company has yet to identify a single drug candidate and indication that can bring home the bacon, so to speak. The catch, however, is that this mystery is probably by design. 

Image source: Getty Images.
The core issue to understand is that the anti-cancer checkpoint modulator field has attracted numerous competitors that are all jockeying for position in an increasingly crowded marketplace. Agenus and its partners, Incyte Corp. and Merck, therefore seem content to apply broad labels such as "solid tumors" to their ongoing clinical studies in an attempt to hide their real intent from potential competitors.  
What we do know is that Agenus has a highly diversified portfolio of checkpoint antibodies that include a CTLA-4, a PD-1, a GITR, and an OX-40 antagonist, among others in pre-clinical development. More to the point, Agenus arguably only needs to hit on perhaps one of its various anti-cancer checkpoint antibodies to be a straight steal at current levels. This biotech, after all, sports a market cap of a mere $340 million at present, meaning that even a checkpoint inhibitor approved as later-line therapy in a crowded field is probably going to generate enough revenue to be a major win for the company's shareholders.

https://www.fool.com/investing/2017/06/05/3-stocks-with-exel…

[Shanghai2006]

This tiny biotech has enormous potential

George Budwell (Agenus): The small-cap biotech Agenus is arguably ridiculously cheap right now because of its exposure to the ultra-high growth field of immuno-oncology. The condensed version is that Agenus has over 10 immuno-modulatory antibodies in either preclinical or clinical development at the moment across a variety of solid tumors. As an added layer of value, the drugmaker has also successfully licensed out a handful of these antibodies to Incyte Corp. and Merck & Co. -- illustrating the industry's immense interest in this rapidly emerging field of anti-cancer therapies.

Getting to the heart of the matter, Agenus' present market cap of $427 million is dirt cheap for a company that sports a diverse pipeline of anti-cancer therapies and two major pharma partners to boot. While it's certainly true that the immuno-modulatory antibody field has attracted a large number of would-be competitors and it might be difficult to carve out a highly profitable niche as a result, the fact of the matter is that Agenus doesn't need any franchise-level drugs to emerge from this effort to be considered grossly undervalued.

Even one drug capable of generating say $200 million in peak sales, for instance, is more than enough to create value for the company's shareholders. And that's a drop in the bucket for a therapeutic field that's forecast to generate somewhere along the lines of $35 billion in annual sales by 2022.

In all, Agenus isn't guaranteed a spot at the high-value checkpoint inhibitor table, but it is working on a class of therapies with a proven track record in the clinic. So with such a diverse pipeline of potent anti-cancer therapies in development, there's a strong chance that this biotech will eventually produce at least a minor commercial-stage checkpoint inhibitor. And that's all this tiny biotech should need to produce respectable returns on capital for its early shareholders.

https://www.fool.com/investing/2017/07/16/3-stocks-that-are-…

[Shanghai2006]

A failure in AstraZeneca's Mystic immuno-oncology drug trial sent shares of fellow cancer-fighters Agenus and Bristol-Myers Squibb tumbling Thursday.

Jul 27, 2017 at 1:26PM

What happened

Shares of Agenus (NASDAQ:AGEN), a small-cap cancer immunotherapy company, were down by almost 16% at 1:20 p.m. Thursday as a result of AstraZeneca's (NYSE:AZN) Mystic trial missing its primary endpoint for progression-free survival in non-small cell lung cancer (NSCLC). Shares of Bristol-Myers Squibb's (NYSE:BMY) , which is pursuing a similar combination therapy for front-line NSCLC, also fell by as much as 6.8% in early morning trading, and were still off by 3.5% at 1:20 p.m.

So what
When checkpoint inhibitor antibodies work, they tend to be wildly successful, producing remarkable responses against a variety of cancers. The key concern, though, is that they only seem to work for 10% to 30% or so of patients -- which means most don't respond to these potentially game-changing therapies. Pharma companies like Agenus, AstraZeneca, and Bristol were all hoping to solve that problem by combining their checkpoint inhibitors with other anti-cancer agents.

Astra's Mystic trial, for instance, sought to tackle front-line NSCLC with a combination of its PD-L1 inhibitor Imfinzi (durvalumab), and the CTLA-4 inhibitor tremelimumab. This high-profile failure, however, suggests that combination therapies may not be a magic bullet after all.

If this proves a harbinger of trial failures to come, Agenus and Bristol could both be in for steep pullbacks. The bulk of Agenus' present value proposition is based on its diverse checkpoint inhibitor pipeline, which is expected to enable it to pursue a variety of novel combination therapies -- and perhaps give it the ability to catch up to industry leaders such as Bristol and Merck.

Bristol, for its part, is hoping to find a winner in the first-line NSCLC setting with a combination remarkable similar to the one being tested in the Mystic trial. Specifically, Bristol is assessing its PD-1 inhibitor, Opdivo, in conjunction with its own CTLA-4 inhibitor, Yervoy, for this high-value indication. After an initial peek at the data earlier this year, the drugmaker decided to forgo an accelerated filing for this combo, suggesting that it may soon follow in the footsteps of Astra's failed combo.

Now what
Astra's Mystic trial could still hit pay dirt if the combination of therapies proves to prolong overall survival compared to standard chemotherapy in the NSCLC setting. The company expects to release results on that metric from the study in the first half of next year. And Bristol is on track to release top-line data from its front-line NSCLC combination therapy study in either late 2017 or early 2018.

Taken together, these two trials could determine the fate of smaller players like Agenus that are trying to break into this highly competitive space. With the enthusiasm for checkpoint inhibitors likely to wane -- at least temporarily -- investors can expect Agenus' stock to move lower in the interim. The checkpoint inhibitor arms race, after all, might start to slow down in a big way following this latest clinical setback.

https://www.fool.com/investing/2017/07/27/did-the-checkpoint…

[Shanghai2006]

Why MYSTIC Failed And How Bristol-Myers Squibb And Agenus Stand To Benefit
Aug. 2.17 | About: Agenus (AGEN)

Tim Erickson

Summary
BMY and AGEN stand to benefit from AZN's immunology missteps. Mounting evidence indicates that as a drug class Anti-PD-L1 Abs (durvalumab/avelumab/atezolizumab) are inferior to Anti-PD1 Abs (nivolumab/pembrolizumab/AGEN2034).
Tremeliumab is a failed IgG2 CTLA-4 inhibitor lacking the ADCC Treg-depleting capabilities of IgG1 CTLA-4 inhibitors ipilimumab and AGEN1884.
Last Thursday, AstraZeneca (AZN) announced interim data from its Phase III MYSTIC trial in lung cancer (NSCLC) revealing that the combined durvalumab/tremeliumumab therapy failed to improve progression-free survival vs. chemotherapy. Not only did this tank AZN's stock, but the announcement sent ripples across the IO space. The valuations of AZN's chief competitors in the CTLA-4 space, Bristol-Myers Squibb (NYSE:BMY) (ipilimumab) and Agenus (AGEN) (AGEN1884), each saw significant declines. MYSTIC trial results left many analysts scratching their heads, and the market priced in future failures in the IO combo space. The purpose of this article is to relay from an immunologists perspective why the AZN combo failed, and where success is likely to lie in future trials. Furthermore, the downdraft in AZN's competitors likely creates a buying opportunity in BMY and AGEN.
So, why did the MYSTIC combo of durvalumab/tremelimumab fail to help patients and improve PFS? Notably, AZN noted that pseudo-progression (tumors becoming inflamed before regressing) was not a factor, so the evidence appears to show that AZN's checkpoint combo did not allow anti-tumor immunity to clear tumor cells faster than the cancer could grow. As anti-PD1 Abs from Merck (NYSE:MRK) and BMY are already approved for NSCLC, it was expected that AZN's (Anti-PD-L1) antibody targeting the same PD-L1/PD-1 axis would also show better efficacy than chemo, and that the addition of tremelimumab (Anti-CTLA-4) would provide an additional boost to the immune system, further enhancing efficacy beyond that of anti-PD1 monotherapy. This did not happen. So, what is the underlying biological reason?

It appears that as a drug class, Anti-PD-L1 antibodies are not as effective as Anti-PD1 antibodies in NSCLC. Why and what is the mechanism? PD1 expressed on activated T cells has at least two ligands, PD-L1 and PD-L2, which can bind to PD-1 and suppress tumor-reactive T cells. While Abs targeting PD1 and PD-L1 can block the interaction between PD-1 and PD-L1, only anti-PD1 Abs can block the interaction between PD1 and PD-L2. This is a fundamental shortcoming of all anti-PD-L1 antibodies. See: PD-L2 is a second ligand for PD-1 and inhibits T cell activation.
PD-L2 is often heavily expressed in lung cancer. (Expression of PD-1 and Its Ligands, PD-L1 and PD-L2, in Smokers and Never Smokers with KRAS-Mutant Lung Cancer - ScienceDirect), the frequent co-expression of PD-L2 in PD-L1 positive NSCLC tumors provides a resistance mechanism against durvalumab (anti-PD-L1) that is overcome by anti-PD1 antibodies. As further evidence of the inferiority of anti-PD-L1 Abs vs. Anti-PD1, Genentech's PD-L1 antibody atezolizumab recently failed to meet its primary endpoint in bladder cancer. Atezolizumab failed Phase III bladder cancer trial.
It is likely that anti-PD-L1 Abs are inferior to anti-PD1 Abs, and this study provides the clearest evidence to date, with a hypothesized resistance mechanism (PD-L2 expression), which is supported by preclinical data as well.
Even with the slight inferiority of PD-L1 Abs, one has to wonder why AZN's anti-CTLA-4 inhibitor was not able to make up sufficient ground to cover for durvalumab's shortcomings. It turns out that tremelimumab is also inferior to ipilimumab. While both antibodies bind to CTLA-4 and block its interaction with CD80/CD86, only "ippy" is capable of depleting tumor-protecting regulatory T cells in sufficient quantities. This is because tremelimumab, which is class IgG2, lacks an IgG1 Fc region, which is required for ADCC-mediated depletion of Tregs. As you may recall, ippy was approved for melanoma, but tremelimumab failed to garner approval due to lack of efficacy. MYSTIC data provides further evidence that IgG2 CTLA-4 inhibitors like tremelimumab are inferior to IgG1 CTLA-4 inhibitors like ipilimumab and AGEN1884.

Despite these key differences, investors without a solid understanding of tumor immunology took the MYSTIC trial data to infer that all PD-1/CTLA-4 combos would have poor efficacy in NSCLC, and other tumor types as well. Given the clear superiority of anti-PD1 Abs and IgG1 anti-CTLA Abs, this leaves both BMY and smaller market cap AGEN with a huge opportunity to conquer various high mutation burden tumors with their differentiated PD1/IgG1 CTLA-4 Ab combos. It is a dramatic overreaction based on a lack of understanding of scientific data that often create opportunities in biotech investing. I was alarmed by how many analysts failed to mention PD-L2 expression or the different functionality of IgG1 vs. IgG2 class antibodies. Events like these will likely create an excellent long-term buying opportunity in the near-term future, enabling above-average investment returns.

http://www.marketwatch.com/investing/stock/AGEN

[Shanghai2006]

Werde meine 100.000 voll machen. Flasche Sekt her.

[Shanghai2006]

Agenus Reports Second Quarter 2017 Financial Results and Provides Corporate Update

Earnings Conference call at 11am ET today

LEXINGTON, Mass., Aug. 3, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, provided a corporate update and reported financial results for the second quarter ended June 30, 2017.

"In the second quarter, we advanced our anti-CTLA-4 and anti-PD-1 antibodies in preparation for initiating combination trials in the second half of this year. We also produced GMP grade product in our facilities in Berkeley and selected a commercial supplier for our lead antibodies. In addition, our partnering efforts are maturing and we expect to close on several transactions in the second half of this year," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We are committed to our path of generating potential first-in-class and best-in-class immuno-oncology agents, and doing so with speed, quality and efficiency."

Anticipated Milestones for H2 2017:
•AGEN1884 (anti-CTLA-4) Phase 1 trial: complete dose-escalation and compile safety and pharmacodynamic data
•AGEN2034 (anti-PD-1) Phase 1/2 trial:
◦Complete dose-escalation for monotherapy, define optimal combination dose and collect safety and receptor occupancy data
◦Recruit patients with second line cervical cancer
•AGEN1884+AGEN2034 Phase 1b trial: commence combination trial
•AutoSynVax™ (neoantigen vaccine): immunological readouts expected in patients with advanced malignancies
•Advance our cell therapy spin off efforts
•Secure substantial funds from existing agreements and future transactions

Recent Highlights:
•AGEN1884 interim data presented at ASCO:
◦Safe at doses up to 3 mg/kg
◦Partial response in a patient with angiosarcoma with 92% reduction in tumor burden at 0.1 mg/kg dose (since ASCO this patient has experienced a complete response)
•QS-21 Stimulon® update:
◦GSK's shingles vaccine containing Agenus' QS-21 Stimulon adjuvant showed strong immunogenicity in patients previously treated with standard of care (Merck's Zostavax®)
◦U.S. regulatory approval of Shingrix is anticipated in Q4
•Manufacturing readiness:
◦Agenus West successful GMP production of AGEN2034 at 1,000L scale
◦Selection of CMOs for production of commercial grade material for planned registrational trials

Second Quarter 2017 Financial Results

Cash, cash equivalents and short-term investments were $96.8 million at June 30, 2017 compared to $76.4 million as of December 31, 2016.

For the six months ended June 30, 2017, Agenus reported a net loss of $48.8 million, or $0.51 per share, compared with a net loss for the same period in 2016 of $60.1 million or $0.69 per share. The decrease in net loss for the six months ended June 30, 2017, compared to the net loss for the same period in 2016, was primarily due to the accelerated milestone payment received from Incyte during the first quarter of 2017. Our operating expenses increased $9.2 million over the same period in 2016.

For the second quarter ended June 30, 2017, Agenus reported a net loss of $31.7 million, or $0.32 per share, compared with a net loss for the second quarter of 2016 of $28.3 million, or $0.33 per share. The increase in net loss for the three months ended June 30, 2017, compared to the net loss for the same period in 2016, was primarily due to the later stage advancement of our programs.

Conference Call, Webcast and Prepared Statement Information

Agenus executives will host a conference call on Thursday, August 3, 2017 at 11:00 a.m. Eastern Time. To access the live call, dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (international) and ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company's website at http://investor.agenusbio.com/presentation-webcasts. A replay will be available on the Company's website approximately two hours after the call and will remain available for 90 days.

http://investor.agenusbio.com/2017-08-03-Agenus-Reports-Seco…

[sdaktien]

Antwort auf Beitrag Nr.: 55.455.528 von Shanghai2006 am 04.08.17 06:38:24

Die Verlustverminderung im gesamten Halbjahr sieht nicht schlecht aus. Wird man das beibehalten können oder muss man in Zukunft mit einer Ausweitung des Verlustes rechnen?

[Shanghai2006]

Wird nach miner Einschaetzung, gleich bleiben oder sich leicht verbessern, durch weitere Einnahmen von Vereinbarungen/Lizenzzahlungen.

[Shanghai2006]

SDAktien, zum Ersten Mal hier? Investiert?
Zur Info/Warnung: Biotech sind meistens High Risk. Also nichts fuer Leute mit Stressanfaelligkeit oder ohne Nerven. Auch braucht man ab und an einen langen Atem, die ganzen Phasen 1-3 Tests sind zeitaufwendig und sehr oft auch ohne Erfolg. Vielleicht ist Lotto spielen besser. lol

[Shanghai2006]

Du musst schon von deinem Pferd/Produkt ueberzeugt sein. Gute Infos haben und dann kann's los gehen. Falls Du in Agenus investiert hast, wird eine interessante Reise. Aber ich denke die haben hier einige gute Stuecke im Lager. Glueck auf!

[sdaktien]

Antwort auf Beitrag Nr.: 55.463.160 von Shanghai2006 am 05.08.17 03:24:17

Nein, Nicht investiert. Ich stelle auch bei Bioteh-Aktien harte Kriterien. Die wenigsten können dise erfüllen. Eine Verminderung von Verlusten macht so eine Aktie für mich aber interessant. Das Unternehmen ist für mich auf einen richtigen Weg.

Das Biotech-Klitschen riskant sind weiss ich auch. Eine schlechte klinische Studie und alles ist vorbei. Aber er reicht ja, wenn es dieses unternehmerische/wissenshaftliche Risiko gibt. Da ist es nicht nötig, den Investor auch noch abzuzocken. Das scheint hier nicht der Fall zu sein und das finde ich gut.

Ich werd die Aktie mal im Hinterkopf behalten.

[Shanghai2006]

Antwort auf Beitrag Nr.: 55.463.856 von sdaktien am 05.08.17 10:16:56

Dann hoer mal rein in die confernece call Aufzeichnung des "Second Quarter 2017 Financial Results". Conference Call, Webcast and Prepared Statement Information Agenus executives will host a conference call on Thursday, August 3, 2017 at 11:00 a.m. Eastern Time.
The call will also be webcast and will be accessible from the Company's website at http://investor.agenusbio.com/presentation-webcasts. A replay will be available on the Company's website approximately two hours after the call and will remain available for 90 days.

[Shanghai2006]

Ich bin hier jetzt seit Anfang 2009, dabei immer wieder gekauft und verkauft.
Bin im Plus und meine Stuecke haben mich nichts gekostet.
Ich habe nur einige Ausnahmen bei denen ich Long bin, da gehoert bisher keine Biotech dazu.
Denke aber das Agenus die Ausnahme wird.

Falls Dich es interessiert meine Longs sind: BMW (1995), Gea Group (2002), Eurofins Scientific (2000) , Wheaton Precious Materials (ehemals Silver Wheaton, 2005), Eckert & Ziegler (2002) BorgWarner (2000, werde ich aber 2018/2019 verkaufen), NVIDIA (2000).

Fuer mich ist NVIDIA die am meisten Potential fuer die Zukunft hat. (Chips fuer Fahrerloses Autofahren, die machen nicht nur Graphikkarten)

[Shanghai2006]

2. Agenus Inc.: Guilt by association

Unfortunately for Agenus Inc., its lead candidates are in the same class as drugs that recently failed in a key combination study for AstraZeneca. Sure, the Mystic trial failure doesn't bode well for a similar combo from Agenus, but I think the stock is in deep value territory once you look at the bigger picture.

Agenus has lost about 33% of its value since Astra revealed that its PD-1 and CTLA-4 checkpoint inhibitors didn't lead to a significant improvement over standard chemo for advanced-stage lung cancer patients that hadn't been treated with anything yet. Missing the mark for this large group of patients that tend to stay on therapy longer than those that have already relapsed suggests lower peak sales potential, but tiny Agenus doesn't need a megablockbuster to more than double your money.

At recent prices Agenus sports a market cap of just $351 million, which means moderate success with just one oncology candidate in its robust pipeline would lead to impressive gains for patient investors. The company's wholly owned PD-1 and CTLA-4 checkpoint inhibitors are still in early to midstage clinical trials, plus Incyte is funding development of candidates aimed at the GITR and OX40 checkpoints in return for a 15% royalty on any future sales if they succeed.

It will be years before we can better estimate the potential in Agenus' pipeline, but I expect the company to burn through cash a relatively slow pace. An application for a shingles vaccine from GlaxoSmithKline that contains an adjuvant Agenus developed is under review at the FDA, and a widely expected approval could lead to a steady royalty stream from the big pharma partner.

https://www.fool.com/investing/2017/08/14/3-beaten-up-biotec…

[Shanghai2006]

Agenus Inc.'s market cap has been pushed down to around $356 million recently for reasons that just don't seem fair. Checkpoint-inhibiting cancer therapies that take the brakes off the immune system so they can fight tumors have been all the rage, until recently. In a nutshell, they seem to produce amazing results for a smaller number of patients than expected.

Agenus owns two checkpoint inhibitors in mid-stage clinical trials similar to those that already generate billions in annual sales. Even if their peak potential has been slashed, they nearly justify the biotech's current price and there's plenty more in the pipeline.

Incyte is funding development of two candidates it licensed from Agenus that inhibit different immune system checkpoints. If successful, Agenus stands to earn some big milestone payments and a 15% royalty on any potential sales.

While we're waiting for earlier-stage drugs in the pipeline to bear fruit, odds are strong that Agenus will begin earning royalties from another partner, GlaxoSmithKline. The pharma giant's shingles vaccine candidate contains a booster it licensed from Agenus, and it's widely expected to earn marketing approvals in the months ahead.

Shingrix royalties probably won't be enough to carry the company all the way to profitability, but they would give Agenus and its partners more time to develop the experimental cancer drugs emerging pipeline. That chance to take plenty of shots on goal makes this a top biotech stock that could be worth a lot more than $5 in the years ahead.

https://www.fool.com/investing/2017/08/19/3-top-biotech-stoc…

[Shanghai2006]

GSK's Shingrix containing Agenus' QS-21 Stimulon® adjuvant receives Unanimous FDA Advisory Committee recommendation for approval
LEXINGTON, Mass., Sept. 13, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that GlaxoSmithKline's (GSK) shingles vaccine candidate, Shingrix, containing Agenus' proprietary immune adjuvant, QS-21 Stimulon®, was unanimously recommended for approval by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee.
"The Advisory Committee's recommendation for the approval of Shingrix marks the first for a product that includes Agenus' proprietary immune adjuvant, QS-21 Stimulon, and serves as a significant validation," said Garo Armen, Ph.D., Agenus CEO and Chairman of the Board. "In addition to being studied in diverse development stage vaccines, QS-21 Stimulon is also a critical component of our neoantigen vaccine formulations. We believe QS-21 provides Agenus with a competitive advantage due to its demonstrated ability to bolster immunogenicity in diverse vaccine formulations offering potential benefit to patients."
A Biologics License Applications (BLA) filed with the FDA by GSK for Shingrix for the prevention of herpes zoster (also known as shingles) in people aged 50 years and older is under regulatory review. The FDA will consider the Advisory Committee vote as it reviews the BLA, although it is not required to follow the recommendation.
GSK's shingles vaccine candidate is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia and Japan are underway
QS-21 Stimulon is being evaluated in various GSK development candidates in addition to being studied in Agenus' neoantigen vaccine, AutoSynVax™, now in a Phase 1 clinical trial.

http://investor.agenusbio.com/2017-09-13-GSKs-Shingrix-conta…

[Shanghai2006]

Sept 13 (Reuters) - A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline's Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over.
Panel members said they were "very impressed" by efficacy data from Shingrix clinical trials, and that it represents an improvement over Zostavax, the only marketed shingles prevention vaccine from Merck & Co.
While the FDA is not required to follow recommendations of its advisory panels, the enthusiasm expressed would seem to indicate that approval is a virtual certainty in coming weeks.
Shingrix is considered one of the more important products in GSK's pipeline, with annual sales forecast to reach $1 billion by 2023, according to Thomson Reuters data.
Zostavax, approved in 2006, is expected to generate sales of about $730 million this year, with declining sales forecast for ensuing years with the introduction of serious competition.
Shingrix contains a component used to help boost efficacy from Agenus Inc, which is entitled to royalties on future sales.
Older people are most at risk of an outbreak of shingles, a painful, often debilitating blistering rash. Shingles is the result of reactivation of the varicella-zoster virus, which causes chickenpox and remains latent in those who have had that disease.
In clinical trials, Shingrix has shown greater protection against shingles among older recipients than that demonstrated by Zostavax. Four years after injection, the GSK vaccine remained about 90 percent effective in people over age 70, while the efficacy of Zostavax declines noticeably over time.
"This is a new generation of vaccine, which really has overcome the age-related decline in immunity," Thomas Breuer, chief medical officer of GSK Vaccines, said in an interview.
Shingrix, given in two doses two months apart, also reduces incidence of nerve pain following a shingles outbreak known as postherpetic neuralgia.
In two pivotal Phase III studies involving more than 29,000 subjects, serious side effects were similar for Shingrix and a placebo. Panelists had questions about a small but greater incidence of certain reported adverse health issues among Shingrix recipients, including gout and stroke.
GSK said it did not believe those were related to Shingrix but has proposed a post-approval safety monitoring plan.
Panelists also expressed concern that the vast majority of trial subjects were white, saying they would like to see more data for other populations.
GSK is expected to announce a U.S. price for Shingrix upon approval. It is also awaiting approval decisions from Europe, Japan, Australia and Canada. (Reporting by Bill Berkrot in New York; editing by Grant McCool and Jonathan Oatis)

https://finance.yahoo.com/news/fda-panel-unanimously-votes-r…

[sufenta]

Antwort auf Beitrag Nr.: 55.806.423 von Shanghai2006 am 23.09.17 06:13:55

Dank Dir für die "updates" bzw. das Reinstellen der Infos.
War mal investiert, mich grad ein wenig reingelesen.
Pipeline ist "traumhaft", in den boards bei yahoo gibts ja unzählige pusher und basher.

Was hast Du für ein realistisches KZ auf 6-12 Monatssicht, wenn das man das bei bei Biotech überhaupt "wagen" sollte, bzw. nach Deinem aktuellen update/der Nachricht, frag ich mich, warum der Kurs noch so tief bei 4$ steht...vor einiger Zeit hatte ich schon gedacht, dass der Kurs, als > 5 stehend, mir davongelaufen wäre...jetzt wäre natürlich wieder DIE Gelegenheit, aber wie gesagt, wunder mich über den aktuellen Kurs...

Dank Dir für Deine Antwort,

Gruss,
s.

[Shanghai2006]

Antwort auf Beitrag Nr.: 55.813.473 von sufenta am 24.09.17 21:30:44

Die Banken geben ein Kursziel vor im Bereich _8-13 USD

Ich persoenlich denke 5,50 - 6,50. Wenn es besser wird einfach genial, und sonst machts auch nicht viel.

Die eine Haelfte bleibt langfristig, mit der anderen Haelfte spiele ich und versuche meinen Anteil staendig zu erhoehen. Und ab und zu gibt es ein schoenes Abendessen mit der Familie.

Aber Biotech sind nicht so einfach, man kann gut mit Ihnen spielen, sehr haeufige Auf und Ab, ausser Du erwischt einen der ein Phase verhaut, dann geht es nur runter.

Biotechs sind meistens mit einer Wundertete zu vergleichen.

[Shanghai2006]

Antwort auf Beitrag Nr.: 55.813.473 von sufenta am 24.09.17 21:30:44

Ach ja, hab noch vergessen zu erwaehnen zuviele spielen mit Biotechs, da wie gesagt hier das auf und ab am groessten ist. Also nichts fuer zu nervoese und herzschwache Spieler.

[Shanghai2006]

Press Release
Shingrix for Shingles, with Agenus Stimulon, Under FDA Regulatory BLA Review
Published: Sept 27, 2017 8:03 a.m. ET

Sep 27, 2017 (ACCESSWIRE via COMTEX) -- NEW YORK, NY / ACCESSWIRE / September 27, 2017 / Traders News Source, a leading independent equity research and corporate access firm focused on small and mid-cap public companies, is issuing a comprehensive report with no obligation on Agenus, Inc. AGEN, +4.81% a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer.

On September 13th, 2017, AGEN announced GSK's shingles vaccine candidate, Shingrix, containing Agenus' proprietary immune adjuvant, QS-21 Stimulon®, was unanimously recommended for approval by the FDA Vaccines and Related Biological Products Advisory Committee.

A Biologics License Applications (BLA) filed with the FDA by GSK for Shingrix is under regulatory review.

When will the FDA complete the BLA review and how will AGEN benefit from Shingrix? READ MORE.
Copy and paste to your browser may be required to view the report - http://bit.ly/2xD8YLD-AGEN-Report.

As per management, The Advisory Committee's recommendation for the approval of Shingrix marks the first for a product that includes Agenus' proprietary immune adjuvant, QS-21 Stimulon, and serves as a significant validation.

In addition to being studied in diverse development stage vaccines, QS-21 Stimulon is also a critical component of AGEN's neoantigen vaccine formulations. The company believes that QS-21 provides it with a competitive advantage due to its demonstrated ability to bolster immunogenicity in diverse vaccine formulations offering potential benefit to patients. Therefore, QS-21 has applications beyond Shingrix in many diverse areas of immunology.

http://www.marketwatch.com/story/shingrix-for-shingles-with-…

[Shanghai2006]

Agenus (AGEN) Presents At Ladenburg Thalmann 2017 Healthcare Conference - Slideshow

Sep.27.17 | About: Agenus (AGEN)

Please follow the link to see the 30 page presentation:
https://seekingalpha.com/article/4109969-agenus-agen-present…

[Shanghai2006]

Albireo Pharma (ALBO) Presents At Ladenburg Thalmann 2017 Healthcare Conference - Slideshow

Sep.27.17 | About: Albireo Pharma, (ALBO)

Please follow this link below for the 23 pages presentation:
https://seekingalpha.com/article/4109943-albireo-pharma-albo…

[Shanghai2006]

Albireo Pharma : EMA's Paediatric Committee Agrees to Albireo's A4250 Pediatric Investigation Plan
09/26/2017 | 02:06pm CEST

Agreement an essential step for a potential EU marketing authorization application
Completion of PIP would provide an additional two years of market exclusivity

Planned Phase 3 clinical trial a key component of agreed PIP

BOSTON, Sept. 26, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has agreed to Albireo's pediatric investigation plan (PIP) for lead product candidate A4250 in patients with progressive familial intrahepatic cholestasis (PFIC). PFIC is a rare and life-threatening genetic liver disease for which there are currently no approved drug therapies.

'Because we are developing A4250 to treat a pediatric patient population, we are especially pleased that the PDCO, which is responsible for activities on potential medicines for pediatric populations and supporting their development in the European Union, has agreed to our pediatric investigation plan for A4250 in PFIC,' said Ron Cooper, President and Chief Executive Officer of Albireo. 'We believe A4250 has the potential with Phase 3 success to make a significant difference in the lives of children suffering from this debilitating rare liver disease and their families. We plan to initiate our previously announced Phase 3 trial of A4250 by year end.'

As part of the regulatory process for the registration of new medicines with the EMA, companies are required to agree with PDCO on a PIP that outlines a development program for the investigational product in the pediatric population. The agreed PIP for A4250 includes Albireo's previously announced double-blind, placebo-controlled, Phase 3 clinical trial in patients with PFIC (type 1 or 2), ages six months to 18 years, as well as Albireo's completed Phase 2 study of A4250 in children with cholestatic liver disease. In addition, the PIP includes a small clinical trial in neonates with PFIC, which will be deferred until after completion of the planned Phase 3 trial, and the development of a liquid formulation.

A4250 has received orphan designation in the European Union (EU) (as well as in the United States) for the treatment of PFIC, which, if maintained at approval, would be expected to provide 10 years of post-approval EU market exclusivity. Completion of the agreed PIP would provide an additional two years of market exclusivity in the EU, making a total of 12 years.

In a recently completed Phase 2 clinical trial in children with cholestatic liver disease, A4250 exhibited a favorable overall tolerability profile, and most patients showed both a reduction in serum bile acid levels and an improvement in pruritus across multiple scales after four weeks of treatment with A4250.

http://www.4-traders.com/ALBIREO-PHARMA-INC-31816183/news/Al…

[Shanghai2006]

Agenus (AGEN) Remains Focused on Drug Development Programs

Notably, Agenus is an immuno-oncology company focused on the discovery and development of checkpoint modulators, vaccines and adjuvants for the treatment of cancer.

In fact, the company has collaboration agreements with a number of companies, which not only provide it with funds in the form of upfront and milestone payments and future royalties but also validate the company’s proprietary product platform. Agenus has formed collaborations with Merck & Co., Inc. MRK and Incyte Corporation INCY to discover and develop multiple checkpoint antibodies.

In February 2017, Agneus and Incyte amended the agreement. The amended agreement converts the ongoing GITR and OX40 antibody programs from co-funded development and profit-sharing arrangements to royalty-bearing programs.

Per the agreement, Incyte will be responsible for funding and conducting global development and commercialization. When any of the two candidates from either of these two programs are approved, Agenus would be entitled to receive 15% royalties on global net sales of each approved product.

Following the amended agreement, Agenus received accelerated milestone payments of $20 million from Incyte related to the clinical development of INCAGN1876 (anti-GITR agonist) and INCAGN1949 (anti-OX40 agonist). Across all programs in the collaboration, Agenus will be eligible to receive up to a total of $510 million for future potential development, regulatory and commercial milestones.

The company’s collaboration agreements with players like Incyte and Merck not only validate its technology platforms but also provide the company with funds.

In fact, we note that the company’s QS-21 Stimulon adjuvant is partnered with GlaxoSmithKline GSK and is a key component in multiple GSK vaccine programs that target prophylactic or therapeutic impact in a variety of infectious diseases and cancer.

Moreover, Agenus’ efforts in developing Prophage vaccine for glioblastoma multiforme are encouraging. It is also exploring different options to advance the Prophage vaccine into a phase III study in newly-diagnosed GBM either alone or in collaboration with a third party. Also, the company is looking for partners to fund studies with plans of retaining commercialization rights in the United States.

The company announced its strategic decision to spin off its cell therapy businesses as a separate unit. Also, it has made this decision so that it can make smaller teams that can entirely focus on getting the products approved. We expect the combined value of the separate companies will far exceed the perceived value under one roof, going forward.

However, Agenus has no approved product in its portfolio. With only a few candidates in mid-stages of development, including Prophage Series vaccine and a number of QS-21 Stimulon-containing vaccine candidates, the company is still a few years away from bringing a product to market. Any hiccup in the development process of these candidates may weigh heavily on the stock. Agenus is highly dependent on its partners for the development of its candidates.

https://finance.yahoo.com/news/agenus-agen-remains-focused-d…

[Shanghai2006]

ETFs with exposure to Agenus, Inc.

Here are 5 ETFs with the largest exposure to AGEN-US. Comparing the performance and risk of Agenus, Inc. with the ETFs that have exposure to it gives us some ETF choices that could give us similar returns with lower volatility.

Fund Name
CNCR-US Loncar Cancer Immunotherapy ETF 3.21%
BTEC-US Principal Healthcare Innovators Index ETF 0.14%
IWC-US iShares Micro-Cap ETF 0.08%
EQWS-US PowerShares Russell 2000 Equal Weight Portfolio 0.03%
VTWG-US Vanguard Russell 2000 Growth 0.02%

http://www.capitalcube.com/blog/index.php/etfs-with-exposure…

[Shanghai2006]

Interesting posters:

http://agenusbio.com/wp-content/uploads/2017/10/EACR-MLL-Pos…

[Shanghai2006]

GSK's Shingrix Containing Agenus' QS-21 Stimulon® Adjuvant Receives Marketing Authorization from Health Canada

First approval for a vaccine enhanced with QS-21 Stimulon®

LEXINGTON, Mass., Oct. 13, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that Health Canada granted marketing authorization to GlaxoSmithKline's (GSK) shingles vaccine, Shingrix, that contains Agenus' proprietary immune adjuvant QS-21 Stimulon® adjuvant. The approval in Canada marks the first approval for Shingrix and the first approval of a vaccine containing QS-21 Stimulon.

In September of this year, Shingrix, was unanimously recommended for approval by the FDA Vaccines and Related Biological Products Advisory Committee. A decision by FDA on whether to approve Shingrix in the United States is anticipated in the coming weeks.
QS-21 Stimulon is an immune-potent adjuvant designed to help the body generate antibodies and T cells, which guard against infection with viruses, parasites and bacteria. The approval of Shingrix in Canada is based on efficacy data collected in more than 37,000 people which demonstrated an efficacy rate against shingles greater than 90%,and this is  independent from age (≥50 and ≥70 years of age), as well as a sustained efficacy over the entire follow-up period. Most common side effects reported in clinical trials were pain, redness and swelling at the injection site and the majority of which were transient and mild to moderate in intensity, lasting less than three days.

"The approval of the Shingrix vaccine containing Agenus' QS-21 Stimulon is a major and most exciting development for the eligible population for GSK, and for Agenus. This approval confirms our belief that the addition of our proprietary immune adjuvant improves vaccine effectiveness and, ultimately, brings benefit to patients," said Garo Armen, Ph.D., Chairman and CEO, Agenus. "The Canadian approval marks the first of further decisions on approvals for Shingrix. We look forward to the FDA decision in the near future."

The addition of QS-21 Stimulon is being studied to determine its potential to help a diverse range of vaccines work more effectively to treat or cure difficult-to-treat diseases, like cancer. QS-21 Stimulon is currently being used in combination with Agenus' neoantigen vaccine, AutoSynVax™, now in a Phase 1 clinical trial in cancer.

QS-21 Stimulon is also currently being evaluated in numerous GSK vaccine development candidates for both therapeutic and prophylactic applications.

http://investor.agenusbio.com/2017-10-13-GSKs-Shingrix-Conta…

[Shanghai2006]

Summary

- Agenus is targeting future cancer treatments exploiting high safety/low dose long-term administration of targeted vaccines.

- Partnership with GSK for Shingrix utilizing the company's adjuvant GS-21 Stimulon obtains unanimous FDA advisory committee approval.

- Agenus and Incyte have a potential $510 million alliance to develop at least five unique antibodies targeting novel molecular target sites.

- The company has revamped its website making it easier to understand its current pipeline.

Agenus (AGEN) is a $460 million market cap company focused on developing immunological technologies and products to treat cancer. The company is testing multiple combination treatment strategies to harness the immune system to fight cancer. By integrating complementary technologies including antibodies and heat shock protein display vaccine vectors, the company has developed a unique arsenal of anti-cancer techniques. AGEN has assembled a vertically integrated platform to develop candidate that when used in conjunction with RetrocyteDisplayTM and HT-CHO verification technologies can self-sufficiently manufacture product candidates. The company has developed ten early stage antibodies with targets including established checkpoint modulators (CTLA-4, TIGIT, GITR, and PD-1, GITR, OX40, TIM-3 and LAG-3). AGEN's lead product is its Glaxo Smith Kline (GSK) partnered Shingrix adjuvant QS-21 for treatment of Shingles and Malaria, with expected approval 2H 2017. The company sold the royalty to GSK for approximately $115 million. AGEN has impressive new alliances with Incyte (INCY) for five candidates and Merck (MRK) for additional undisclosed candidates.

AGEN believes (and industry-wide it is being proven) that the ability to profile patients and design combination therapies will be key drivers of success in immuno-oncology, and has refocused its business model to do so. What better way to design a clinical trial than admitting only the highest-probability success candidates? Such combination therapies can include checkpoint modulating antibodies designed to enhance immune response to cancer and will aid in anti-cancer escape. By blocking several checkpoint immune molecular mechanisms simultaneously, there is evidence that a more robust anti-tumor immune response can be generated in contrast to single checkpoint modulators alone. AGEN technologies and strategies involve combination approaches that utilize proprietary platforms to uniquely and potentially very powerfully combine checkpoint antibodies, cancer vaccines, and vaccine adjuvants. For that reason Strong Bio is strongly recommending keeping a watchlist eye on clinical trial results of this impressive pipeline. Note that the company reported data at AACR in four separate immune checkpoint poster presentations in 2017.

AGEN's lead product is its Shingles/Malaria adjuvant QS-21, which recently reported (GSK, Zoster-048) positive phase 3 results in June 2017. GSK reported its shingles vaccine candidate, Shingrix (containing Agenus' proprietary immune adjuvant, QS-21 Stimulon®) triggered a strong immune response in elderly patients previously treated with the current vaccine, Zostavax®. Phase 3 data was reported at US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. The company expects regulatory approvals in 2H 2017. GSK filed for regulatory approval in Japan in addition to existing filings for US, Canada and EU. The company anticipates GSK's malaria vaccine containing QS-21 to be distributed in select African countries at the recommendation of World Health Organization in 2H 2017. QS-21 Stimulon is also being evaluated in conjunction with Agenus' neoantigenvaccine, AutoSynVax™, in a phase 1 clinical trial, with key immunological readouts expected in late 2017. This study is expected to generate preliminary results for combination checkpoint modulator profile analysis later this year. The company also announced a phase 2 clinical collaboration to explore candidate vaccine Prophage with the National Cancer Institute in combination with Keytruda (MRK). The study will measure overall survival rate in patients with newly diagnosed glioblastoma.

AGEN1884, an anti-CTLA-4 checkpoint antagonist, initiated phase 1 clinical trials in April 2016. CTLA-4 is a negative regulator of T-cell activation. The first CTLA-4 inhibiting antibody to be developed was Ipilimumab (Yervoy, BMY) which has shown to have anti-cancer effects by activating T-effector cell tumor infiltration, particularly for skin cancer. AGEN CTLA-4-targeting Phase 1 dose-escalation trial results for candidate AGEN1884 in patients with advanced solid malignancies were reported in a poster session at ASCO 2017. The antibody demonstrated strong safety and tolerability, and one patient was shown to undergo a 92% reduction in tumor volume at 33 weeks AGEN1884 treatment. AGEN1884 is being developed in collaboration with Ludwig Cancer Research, 4-Antibody AG and Recepta Biopharma S. A. (South America). AGEN1884 is partnered with ReceptaBiopharma S.A. for certain South American rights. Agenus has put in place measures for successful GMP production for large scale manufacturing readiness. Regimens involving lower and less frequent dosing of CTLA-4 antibody in combination with PD-1 inhibitors yielded a more pronounced clinical efficacy than either agent alone. Importantly, this was achieved without additive toxicity. Some experts now believe that the combination of CTLA-4 and PD-1 antibodies using a tolerable dosing regimen is going to emerge as a foundational immuno-oncology regimen. Current unilateral treatment regimens attack cancers aggressively and in some cases are highly toxic, which may "force" tumor escape. Strong Bio regards less aggressive heterogeneous combinatory targeting of cancer signaling molecules as a potentially powerful future approach to prevent tumor escape. AGEN retains world-wide rights of its checkpoint inhibitor antibodies, except in South America, which are controlled by Recepta Biopharma.
Patient enrollment was initiated Q1 2017 for phase 1/2 clinical trials for AGEN2034, a PD-1 antagonist, in advanced solid tumors and cervical cancers. The antibody targets PD-1 (programmed cell death protein 1 antagonist) expressed on activated T cells. PD-1 blockade with checkpoint antibodies has been shown to be efficacious and sometimes curative in melanoma and lung cancer patients. AGEN1884/AGEN2034 combination Phase 1b clinical trials were initiated 1Q 2017, paving the way for a rapid path to registration given robust anti-cancer results. The company also intends to pursue combinations of PD-1 and CTLA-4 antibodies with its neoantigencancer vaccines, having initiated phase 1 clinical trials in April 2017. Checkpoint inhibitor cancer immunotherapies are a hot area of active pharmacological research.

INCAGN1876 is a GITR agonist antibody being developed in an impressive global alliance with Incyte (INCY). INCAGN1876 entered clinical trials in 2016. GITR (glucocorticoid-induced TNFR-related protein) is a receptor expressed on select populations of T cells. Activation of GITR can lead to a more powerful anti-tumor inflammatory response, increased production of inflammatory signaling molecules, promote durable CD8+ T-cell-dependent antitumor immunity, and increased long-lasting resistance to immunosuppression.
INCAGN1949 is an agonist antibody targeting OX40, also in the INCY alliance, which entered clinical trials in 2016 as well. OX40 (also known as CD134 and TNFRSF4), a member of the TNFR super-family, is an immune response-enhancing receptor found on activated T cells. Low-dose combination therapy using checkpoint modulators including OX40 agonists have been shown to induce tumor regression by promoting proliferation of activated T cells with concurrent down-regulation of immunosuppressive T-cell activity. Timing of PD-1 blockade has been shown to be synergistic with Anti-OX40 efficacy. AGEN is strategically positioned to critically examine additive effects of combination therapies in these powerful anti-cancer signaling cascades. The program to develop four candidates funded by Incyte cover significant development expenses and carry varying royalties for each candidate as well. The market for solid tumors is expected to grow at nearly 7%.
Also included in the INCY alliance are two other early stage preclinical antagonist candidates targeting TIM-3 and LAG-3, showing promise in scientific study for T-cell responses and chronic infection. TIM-3 stands for T -cell immunoglobulin and mucin domain-3. To prevent over-activity of the immune system in the natural state, ligands binding to TIM-3 reduce the activity of these immune cells and keep autoinflammation under control. TIM-3 may serve as a prognostic marker for patients with solid tumors, overexpression of which is correlated with shorter OS in 7 clinical studies. In some types of cancer, T cells express elevated levels of TIM-3, which results in excessive immune suppression. LAG-3 (lymphocyte-activation gene 3) modulates signaling between immune cells and their interactive targets as well. When LAG-3 is activated, immune response is suppressed. Antibodies that block LAG-3 can block this inhibitory signal, restoring immune activity and function. LAG-3 may be particularly useful in treatment of hematological malignancies, which is expected to reach a world-wide market size of a whopping 85.5 billion by 2025, according to Grandview Research. These program is funded by Incyte with Agenus eligible for potential milestones and royalties.

The company showed cash equivalents of $124 million as of end Q1 2017. End Q2 cash and cash equivalents were about $82 million. Agenus reported a net loss of $17.1 million compared with a net loss for the 1Q 2016 of $31.8 million. The decrease in net loss for Q1 2017 compared to Q1 2016 was primarily due to milestone payment received from INCY. Cash infusion from INCY will stave off expenses in a $510 million dollar potential deal, with $80 milllion in cash and $70 million in cost sharing over the next 15 months. INCY will provide all funding for GITR and OX40 clinical programs. Assuming a burn rate of $32 million per quarter, this should provide a cash runway into deep 2019. Outstanding debt is approximately $136 million as of June 30, 2017. This is a manageable amount of debt for the industry but is something to keep an eye on into the future.
The company has a $100 million potential deal with MRK on an undisclosed product under development, and has yet to get its final $15 million milestone payment by GSK for FDA approval of QS-21 Stimulonadjuvant-utilizing product vaccines. Taken together, its burn rate may stretch even longer while its pipeline generates potential game-changing phase 2 results in cancer efficacy, with its focus on blocking tumor escape. Such approaches are expected by Strong Bio to have reasonably favorable probability of being met with efficacy that may warrant FDA Breakthrough Therapy Designation. These clinical targets that AGEN is developing as combinatory therapies should be considered as potentially "explosive" in terms of potential cancer treatment efficacy. With a relatively small market cap and out-licensing potential, the reward to risk ratio looks favorable as well. Strong Bio has AGEN on the phase 2 watchlist, with an eager eye on the combination studies, especially with respect to vaccine technology and potential immune system memory and anti-escape effects. With GSK, INCY, and MRK on its partnering list, they are well-positioned to take advantage of well-respected expertise and development as well. 4 analyst consensus is $8.70 per share. Strong Bio has interest in a position, and would consider a pullback or dilutive event as an opportunity.

Risks for the company involve bringing a revenue-producing product to market without having to sell it to support its pipeline. Competition in the checkpoint space is steep and filled with big pharma representation, so it will have to show clear advantages in its indications, but certainly has that potential. Obstacles of FDA approval and manufacturing are also risks, but interestingly, the company has taken measures to prove that it has large scale in-house manufacturing ability. Dilution is a significant risk here too, but with a couple of promising phase 2 studies and anything worthy of FDA Breakthrough Therapy Designation, funding should come fairly easily AGEN. The company has some debt to overcome as well, and that could increase. There is always a risk of immune system over activation as well when dealing with checkpoint inhibitors. If multiple checkpoint inhibitors are blocked, it could lead to very serious autoimmune or hyperinflammatory states, but given the outcome of cancer gone unchecked, we as a field have no choice but to press forward in this area. AGEN is doing so in a responsible low-dose manner.

https://seekingalpha.com/article/4112544-agenus-loads-impres…

[Shanghai2006]

FDA Approves GSK's Shingles Vaccine with Agenus' QS-21 Stimulon® Adjuvant

- SHINGRIX containing QS-21 Stimulon® demonstrates remarkable efficacy of greater than 90% in pooled studies against shingles

- Shingles is a major public health issue in the US, impacting as many as 1 in 3 adults over the age of 50 years

LEXINGTON, Mass., Oct. 20, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Food and Drug Administration (FDA) granted marketing authorization to GlaxoSmithKline's (GSK) herpes zoster vaccine, SHINGRIX, containing Agenus' proprietary immune adjuvant QS-21 Stimulon®. SHINGRIX is indicated for prevention of herpes zoster (also known as shingles) in adults aged 50 years and older. The addition of QS-21 Stimulon helps improve the vaccine's effectiveness by boosting immune response in older adults who often experience age-related decline in immunity.   

Shingles is a major public health issue in the US, impacting as many as 1 in 3 older adults over the age of 50 years. Shingles is caused by a virus called varicella zoster, which is also known as the chicken pox virus. Nearly all older adults have the varicella zoster virus dormant in their nervous system waiting to reactivate with advancing age and weakened immune systems.
QS-21 Stimulon is an immune-potent adjuvant designed to boost the immune system by helping the body generate antibodies and T cells that guard against infection. The addition of QS-21 Stimulon to the SHINGRIX vaccine enhances the immune response in these older adults.

"We are delighted by the remarkable efficacy of SHINGRIX, containing our proprietary QS-21 Stimulon adjuvant and the public health benefit; this FDA approval marks a significant milestone for Agenus," said Garo Armen, Ph.D., Chairman and CEO, Agenus. "The addition of QS-21 Stimulon enhances the immunogenicity of SHINGRIX and is beneficial in an older adult population who often experience a decline in immunity.  Beyond shingles, our QS-21 Stimulon is under investigation in numerous vaccines and is a critical component of our neoantigen vaccine formulation, which is currently advancing in a Phase 1 clinical trial in patients with cancer."

The FDA approval of SHINGRIX was based on data pooled from two pivotal Phase III clinical trials in more than 37,000 people, which demonstrated an efficacy rate against shingles greater than 90% independent of age, as well as a sustained efficacy over the four-year follow-up period. SHINGRIX also reduced the overall incidence of postherpetic neuralgia (PHN), the most common and oftentimes debilitating chronic nerve pain associated with shingles. The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of shingles. The most common side effects reported in clinical trials of SHINGRIX were pain, redness and swelling at the injection site, the majority of which were transient and mild to moderate in intensity, lasting less than three days.

The addition of QS-21 Stimulon is being studied to determine its potential to help a diverse range of vaccines work more effectively to treat or cure difficult-to-treat diseases, like cancer. QS-21 Stimulon is currently being used in combination with Agenus' neoantigen vaccine, AutoSynVax™, now in a Phase 1 clinical trial in cancer.

QS-21 Stimulon is also currently being evaluated in numerous GSK vaccine development candidates for both therapeutic and prophylactic applications.

http://investor.agenusbio.com/2017-10-20-FDA-Approves-GSKs-S…

[Shanghai2006]

Why Agenus Inc. Stock Slumped Today

George Budwell, The Motley Fool
Motley FoolOctober 20, 2017

What happened
Shares of the cancer immunotherapy and vaccine company Agenus (NASDAQ: AGEN) fell by as much as 16.7% on nearly five times the average volume today, before ultimately ending the day down by only 5.1%. This sizable move lower was triggered by a $250 million mixed shelf offering that the company plans to use for general corporate purposes.
According to the accompanying prospectus, general corporate purposes may include "working capital, capital expenditures, repayment and refinancing of debt, research and development expenditures, clinical trial expenditures, acquisitions of additional companies or technologies and investments."

So what
A $250 million shelf offering is nothing to sneeze at in any case -- especially for a company with a current market cap of only $443 million. However, this massive shelf registration makes a lot of sense for Agenus.
Agenus' early-stage checkpoint-modulator pipeline won't produce a regulatory filing until at least late 2020, according to the company's latest investor presentation. So until 2021, or perhaps even longer, Agenus is almost certainly going to be heavily dependent on stock offerings to stay afloat.  

Now what
Another important point to consider is that Agenus doesn't have to tap this offering in its entirety, and it probably won't unless circumstances dictate otherwise. Long story short, this double-digit sell-off probably wasn't warranted, for the most part.
Secondary offerings, after all, are par for the course when it comes to clinical-stage biotechs. Moreover, there's no compelling reason to think Agenus' management would roll out the common-stock portion of this shelf registration in a manner that would significantly harm its current shareholder base via dilution.
   
The bottom line is Agenus' future success -- or failure -- is going to depend on the fate of its diverse anti-cancer platform. If the company strikes gold with one or more of its immune modulators, this shelf registration won't really matter in the larger scheme of things. And the same probably can be said in the event that its checkpoint-inhibitor pipeline turns out to be a dud.

https://finance.yahoo.com/news/why-agenus-inc-stock-slumped-…

[Shanghai2006]

GlaxoSmithKline adult shingles vaccine wins U.S. approval

ReutersOctober 21, 2017

Oct 20 (Reuters) - The U.S. Food and Drug Administration approved GlaxoSmithKline's Shingrix shingles vaccine for use in adults aged 50 and over, a move widely expected after an advisory panel to the agency last month voted unanimously to recommend its approval, the company announced on Friday.

Shingrix is seen as an improvement over Zostavax, the only currently marketed shingles prevention vaccine, sold by Merck & Co.
The vaccine is considered one of the more important products in Glaxo's pipeline, with annual sales forecast to reach $1 billion by 2023, according to Thomson Reuters data.
Glaxo said the U.S. Centers for Disease Control and Prevention's advisory committee on immunization practices is expected to vote on a recommendation for the use of Shingrix at its meeting on Wednesday.
The company said it expects Shingrix "will be available shortly."

The vaccine demonstrated its efficacy in two pivotal Phase III studies involving more than 29,000 subjects.

Shingrix has shown greater protection against shingles among older recipients than Zostavax. Four years after injection, the Glaxo vaccine remained about 90 percent effective in people over age 70, while the efficacy of Zostavax declines noticeably over time.
Older adults are most at risk for an outbreak of shingles, a painful, often debilitating blistering rash that results from reactivation of the varicella-zoster virus, which causes chickenpox and remains latent in those who have had that disease.
Given in two doses two months apart, Shingrix also reduces incidence of nerve pain following a shingles outbreak.
Shingrix contains a component used to help boost efficacy from Agenus Inc, which is entitled to royalties on future sales.
The vaccine won its first approval in Canada last week and is awaiting approval decisions in Europe, Japan and Australia. (Reporting by Bill Berkrot and Deena Beasley; Editing by Sandra Maler)

https://finance.yahoo.com/news/glaxosmithkline-adult-shingle…

[Shanghai2006]

After closing Agenus stock up 0.74$ to 5.07$.
Over 4.7 million stocks traded today, that is over the 3 month average of 1.1 million per day.

[Shanghai2006]

War ja klar das die FDA das Zeug approved. Zum Glueck noch kraeftig nachgekauft nachdem Kanada approved hatte vor einer Woche.

[Shanghai2006]

GSK wins U.S. shingles vaccine approval, UK nod for gene therapy

Ben Hirschler, 23.October 2017

LONDON (Reuters) - GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three key products for which the British drugmaker expects approval this year.

It also secured a recommendation from UK cost authorities for a $700,000 gene therapy for so-called “bubble boy” disease -- a step forward for the field of fixing faulty genes but a tiny sales opportunity. Only three patients have received the gene therapy commercially since its May 2016 approval in Europe.

The green light for GSK’s shingles shot Shingrix, which has proved significantly better than Merck & Co’s Zostavax in clinical trials, is an important vindication of GSK’s product pipeline. The news was announced late on Friday.

GSK’s vaccine is considered one of the more pivotal products in its pipeline, with annual sales forecast to reach 1.03 billion pounds ($1.36 billion) by 2023, Thomson Reuters data shows.
“Although largely expected, today’s approval is an important one for GSK -- a new product with a clear best-in-class profile,” Berenberg analysts said on Monday. “We expect approval in Europe late this year.”

The U.S. Food and Drug Administration (FDA) approval comes a month after it cleared GSK’s three-in-one inhaler for chronic lung disease.

The third new product GSK expects to launch in the world’s biggest drugs market is a dual-drug regimen for HIV, on which the U.S. regulator is scheduled to give a verdict by Dec. 1.

Chief Executive Emma Walmsley, who will present third-quarter financial results on Wednesday, sees the three products as “critical” for GSK’s efforts to fill the revenue gap left by falling sales of the aging lung drug Advair.

The FDA approved Shingrix, which is given in two doses, for adults aged 50 and over. Approval had been expected after an advisory panel to the agency backed the product.
Shingrix is more effective than Zostavax, the only currently available shingles prevention vaccine, which is given as a single dose. GSK said it expects Shingrix to be “available shortly”.

IMMUNIZATION COMMITTEE
The U.S. Centers for Disease Control and Prevention’s advisory committee on immunization practices is expected to vote on a recommendation for the use of Shingrix at its meeting on Wednesday.
The outcome of that meeting may determine just how big the product becomes.
Many analysts expect the committee to recommend routine vaccination of the over-60s, as is currently the case with Zostavax, but an endorsement of use in younger people would represent commercial upside.

Older adults are most at risk of shingles, a painful, often debilitating blistering rash that results from reactivation of the varicella-zoster virus that causes chickenpox and remains latent in those who have had that disease.

Shingrix contains a component from Agenus, which is entitled to royalties on future sales.

Meanwhile, Britain’s National Institute for Health and Care Excellence (NICE) said on Monday that it had approved GSK’s gene therapy Strimvelis for treating ADA-SCID -- better known as “bubble boy” disease -- despite its steep price tag of 594,000 euros ($698,000).
Infants with the condition need to be kept in isolation to avoid infections and the cost to the state health service can run to millions of pounds, so a one-off genetic cure can prove cost-effective even at a very high price.

http://in.reuters.com/article/us-usa-fda-gsk/gsk-wins-u-s-sh…

[Shanghai2006]

Europa approval soll folgen bis Ende diesen Jahres. Naja, dann geht das ja noch etwas hoeher.

[Shanghai2006]

Why Agenus Inc. Stock Briefly Popped Today

After the market had time to reflect on Agenus' new CAR-T venture, investors were unimpressed by its prospects.

George Budwell
Oct 23, 2017 at 12:06PM

What happened
Agenus (NASDAQ:AGEN), a clinical-stage cancer immunotherapy company, saw its shares open up 13% higher Monday on trading volumes nearly six times the daily average. The move came in response to its launch of a new immuno-oncology subsidiary called AgenTus Therapeutics, Inc.

The biotech's new venture will focus on the development of adoptive cell therapies, such as chimeric antigen T cell receptor therapies (CAR-T), and T cell receptors (TCRs) designed to treat both solid tumors and various types of blood cancers. Despite that brief double-digit spike, however, Agenus' stock almost immediately began to cool off, fell into the red for a few minutes late in the morning, and as of noon EDT, was trading up by only around 2%.

So what
Adoptive cell therapies have been in the spotlight over the past few weeks because of Gilead Sciences' $12 billion buyout of Kite Pharma -- along with the back-to-back regulatory approvals of Gilead/Kite's CAR-T therapy Yescarta and Novartis' Kymriah. Genetically modified cell therapies have rapidly come of age as potent anti-cancer treatments, and Agenus apparently wants to get in on the action.

Now what
While adoptive cell therapies are now a validated anti-cancer platform, Agenus is probably way too late to this particular party to derive much of a benefit. Gilead and Novartis already have the first-mover advantage, after all, and a slew of other companies such as Bellicum Pharmaceuticals, bluebird bio., Celgene, Juno Therapeutics, and ZioPharm Oncology -- to name just a few -- are also racing to bring their own cell-based cancer therapies to market within the next few years.

The bottom line is that Agenus' adoptive cell-based therapy venture doesn't seem to have much a chance in light of the prevailing market conditions, which is probably why its 13% spike Monday didn't last long.

https://www.fool.com/investing/2017/10/23/why-agenus-inc-sto…

[Shanghai2006]

Shingrix with QS-21 Stimulon® Receives Positive Recommendation from CDC's Advisory Committee on Immunization Practices as Preferred Vaccine for Prevention of Shingles

LEXINGTON, Mass., Oct. 25, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of three recommendations for the use of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) containing QS-21 Stimulon® for the prevention of shingles (herpes zoster):
Herpes Zoster subunit vaccine (Shingrix) is recommended for the prevention of herpes zoster and related complications for immunocompetent adults age 50 year and older.
Herpes Zoster subunit vaccine (Shingrix) is recommended for the prevention of herpes zoster and related complication for immunocompetent adults who previously received Zoster Vaccine Live (Zostavax).
Herpes Zoster subunit vaccine (Shingrix) is preferred over Zoster Vaccine Live (Zostavax) for the prevention of herpes zoster and related complications.

"The Advisory Committee's vote to recommend Shingrix enhanced with QS-21 Stimulon on three different counts further confirms our belief in the vaccine's efficacy and its potential to extend immunization for up to 62 million adults in the United States," remarked Garo Armen, Ph.D., Chairman and CEO, Agenus. "Today's vote confirms the importance of ensuring that millions of at-risk adults are protected against shingles with Shingrix."
QS-21 Stimulon is an immune-potent adjuvant designed to boost the immune system by helping the body generate antibodies and T cells that guard against infection. The addition of QS-21 Stimulon enhances the immunogenicity of Shingrix by boosting immune response, which is critically important for older adults, the population most vulnerable to shingles and the painful and often debilitating consequences of the virus.
Shingrix was approved by the US Food and Drug Administration (FDA) on October 20, 2017 for use in adults aged 50 years and older. Data from studies of people vaccinated with Shingrix, who were previously vaccinated with Zostavax, have been presented previously to the ACIP and have been published in peer-reviewed journals, but have not yet been reviewed by the FDA.,[ii] 
The most common side effects of Shingrix are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach, which are related to the immune system responding to the vaccine. Based on available data, the majority of reactions to the vaccine were transient and mild to moderate in intensity, lasting less than three days.
Shingles is a major public health issue in the US, impacting as many as 1 in 3 older adults over the age of 50 years. Shingles is caused by a virus called varicella zoster, which is also known as the chicken pox virus. Nearly all older adults have the varicella zoster virus dormant in their nervous system waiting to reactivate with advancing age and weakened immune systems.
The ACIP recommendations will be forwarded to the director of the CDC and the US Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (MMWR).

http://investor.agenusbio.com/2017-10-25-Shingrix-with-QS-21…

[Shanghai2006]

Agenus Receives License Fee of $4 Million USD from Merck

Entitled up to an additional $99 million USD in success milestones plus royalties on sales

LEXINGTON, Mass., Nov. 15, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, today announced the receipt of a $4 million payment for the advancement of an undisclosed antibody under the license and research collaboration agreement with Merck, known as MSD outside the United States and Canada.
As previously announced, Merck is responsible for all future product development expenses for the selected antibody and Agenus is eligible to receive up to an additional $99 million in milestone payments, as well as royalties on worldwide product sales.
"We are very pleased with the progress of our collaboration with Merck and the advancement of this antibody towards the clinic," said Garo Armen, Ph.D. Chairman and CEO of Agenus. "Our integrated antibody discovery platforms and expertise culminates in discovering antibodies for a broad range of targets, including challenging ones, as was the case with this particular candidate."

http://investor.agenusbio.com/2017-11-15-Agenus-Receives-Lic…

[Shanghai2006]

Usefull FDA link:

https://www.fda.gov/aboutfda/workingatfda/ethics/ucm079670.h…

[Shanghai2006]

Agenus Announces Key Leadership to Advance Combination Trials For Planned BLA Filings

PR Newswire January 03, 2018
-- Hagop Youssoufian, MD, named Senior Clinical Strategist

-- John Castle, Ph.D., appointed as Head of Translational Medicine and Bioinformatics

-- Tyler Curiel, MD, MPH named Senior Strategist for Translational and Biomarker Development

LEXINGTON, Mass., Jan. 3, 2018 /PRNewswire/ -- Agenus Inc. (AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced new leadership appointments to enhance its team and advance combination clinical programs which will support its planned BLA filings in the second half of 2019 and in 2020.

Dr. Youssoufian will serve as Senior Clinical Strategist to provide overall strategic and tactical guidance to Agenus' clinical team for the advancement of our ongoing lead combination programs. Dr. Youssoufian brings over 25 years of product development and approval experience, particularly in biologics.

Dr. John Castle is a pioneer in translational bioinformatics and genomics and leader in the identification of immune-inducing antigens for cancer therapy. Dr. Castle will drive the application of mutational and biochemical based neoantigens for the development and evaluation of effective cancer treatments.

Dr. Tyler Curiel is appointed Senior Strategist for Translational and Biomarker Development. Dr. Curiel is a world-renowned physician-scientist and trained immunologist, past chief of hematology and medical oncology and executive director of an NCI-designated cancer center. Drs. Castle and Curiel will drive the translational and biomarker approaches to select patients most likely to benefit from combination approaches of our vaccines, adjuvants, and checkpoint modulating antibodies targeting T cells, tumor micro-environment conditioning, and regulatory T cell depletion strategies.

"These appointments will help drive landmark advances in cancer treatments here at Agenus," said Dr. Garo Armen, Chairman and CEO. "These experts share our vision to quickly bring effective combination approaches to patients with cancer and will advance our currently ongoing pivotal programs with CTLA-4 and PD-1 designed to support a BLA filing in the second half of 2019."

Dr. Hagop Youssoufian brings more than 25 years of drug development expertise with specific experience in the development of protein-based therapeutics. Hagop has served in various senior roles in the pharmaceutical and biotechnology industry, including tenures as Chief Medical Officer at ImClone-Lilly and as President of R&D at Ziopharm and was involved in the development and approval of several oncology biologic products, including Erbitux® and Cyramza®. He is an elected member of the American Society for Clinical Investigation. Hagop received his Bachelor of Science from Boston College, his medical degree from the University of Massachusetts Medical School and completed training in Internal Medicine and fellowship in Clinical Genetics at Johns Hopkins and in Hematology-Oncology at Massachusetts General Hospital. Hagop was a Visiting Scientist at Whitehead Institute with subsequent academic positions at Harvard Medical School and Baylor College of Medicine.

Dr. John Castle is a pioneer in the identification of immunogenic antigens for application in cancer treatment. At Agenus, Dr. Castle revolutionized our neoantigen approach to vaccines from an autologous approach to a computationally driven, fully synthetic, off-the shelf approach to cancer therapy. He previously served in leadership positions at TRON and BioNTech AG (Mainz, Germany), where he built translational bioinformatics and genomics departments focused on immunotherapies. Under his leadership, these organizations pioneered approaches to identify immunogenic tumor mutations. John spent his early career at Rosetta Inpharmatics, later part of Merck & Co, where he gained expertise in integrating bioinformatics, computational immunology, biotechnology and genomics. John studied physics at Rice University, received his PhD from the University of Washington, and completed his post-doctoral studies at the Massachusetts Institute of Technology.

Dr. Tyler Curiel is a Professor of Hematology/Oncology in the Department of Medicine at University of Texas Health San Antonio (UTHSA), where he also holds the Daisy M. Skinner President's Chair in Cancer Immunology Research. Tyler is a physician-scientist and world recognized expert in tumor immunology and immunotherapy, Phase 1 experimental therapeutics and gynecologic cancers. He is board certified in internal medicine, infectious disease, and medical oncology. He is past chief of hematology and medical oncology and executive director of an NCI-designated cancer center and leads the Experimental and Developmental Therapeutics Program at UTHSA. Tyler is a leading expert in PD-L1/PD-1 immune-biology and regulatory T cells will serve as our Strategic Advisor of Translational Medicine.

[Shanghai2006]

Agenus inks $230M royalty monetization deal; shares up 14% premarket

Jan. 8, 2018 9:19 AM ET|About: Agenus (AGEN)|By: Douglas W. House, SA News Editor

•Agenus (NASDAQ:AGEN) is up 14% premarket on robust volume in response to its monetization deal with HealthCare Royalty Partners (HCR) for vaccine-related QS-21 royalties.

•Under the terms of the transaction, Agenus will receive $230M, $190M in cash and $40M in milestones, in exchange for royalties on net sales of GlaxoSmithKline's (NYSE:GSK) QS-21-containing vaccines.

•Agenus retains all rights to develop QS-21 with its internal lineup of checkpoint antibodies, vaccines and cellular therapies.

•It will use a portion of the proceeds to redeem its royalty bond from Oberland and addition funds to advance studies of QS-21 with anti-CTLA-4 and anti-PD-1 therapies.

•At closing, Agenus expects to have ~$28M after the Oberland transaction. It can also earn up to $40M in milestones, but will owe HCR ~$26M in 2021 if certain sales milestones are not met.

•Glaxo's Shingrix shingles vaccine, approved in the U.S. in October 2017, contains Agenus' QS-21 adjuvant Stimulon.

https://seekingalpha.com/news/3321618-agenus-inks-230m-royal…

[sufenta]

Irgendwie sagt mir mein Gefühl, dass eine Übernahme kommen könnte...so um die 10-12$ wäre nicht schlecht...Volumina der letzten Tage war auch nicht schlecht...mal schauen...Bellicum übrigens auch stark am Kommen...da scheinen die 10$ auch nur noch eine Zeitfrage....drücken wir uns die Dauem....

[Shanghai2006]

Agenus earns second $4M milestone payment from Merck
Aug. 15, 2018 1:44 PM ET|About: Agenus (AGEN)|

- Agenus (AGEN -4.7%) announces that it has received a $4M milestone payment from Merck (MRK +0.5%) triggered by the initiation of a Phase 1 clinical trial of an undisclosed antibody discovered by Agenus.

- Under the terms of their 2014 contract, Agenus is eligible to receive up to an additional $95M in development and regulatory milestones plus royalties on global net sales.

-It received its first milestone payment, also $4M, in November 2017.

-Previously: Agenus receives $4M from Merck for advancement of antibody (Nov. 15, 2017)

https://seekingalpha.com/news/3383218-agenus-earns-second-4m…

[Shanghai2006]

Quarter 3 report:

https://seekingalpha.com/filing/4229144

[Shanghai2006]

Agenus teams up with Gilead to develop five I-O therapies; shares up 72% premarket
Dec. 20, 2018 7:49 AM ET|

Agenus (NASDAQ:AGEN) is up 72% premarket in reaction to its collaboration with Gilead Sciences (NASDAQ:GILD) to develop five immuno-oncology (I-O) therapies.

Under the terms of the agreement, AGEN will receive $150M upfront, a $30M equity investment from GILD and up to $1.7B in milestones. GILD will receive global rights to AGEN1423 (IND to be filed by month-end) and an exclusive option to license AGEN1223 and AGEN2373 (IND filed for the former and IND on tap for H1 2019 for the latter). AGEN has the right to share in development and commercialization in the U.S. GILD will have the right of first negotiation for two additional preclinical programs.

https://seekingalpha.com/news/3418445-agenus-teams-gilead-de…

[Shanghai2006]

Agenus in-licenses Selexis protein production platform
Jan. 9, 2019 10:44 AM

Swiss biotech Selexis SA has inked additional license agreements with Agenus (AGEN -1.2%) under which the latter will employ its modular SUREtechnology platform to support therapeutic protein production.

Selexis says SUREtechnology improves the way mammalian cells are used in the discovery, development and manufacturing of recombinant proteins and drugs.

https://seekingalpha.com/news/3421798-agenus-licenses-selexi…

[Shanghai2006]

Agenus Gets A Grant: A Good Opportunity To Buy
Jan. 11, 2019 1:44 PM E

Summary
Agenus received a $1 million grant from the Bill & Melinda Gates Foundation.

The company’s lead candidates showed successful phase I/II results.

The unique portfolio of antibodies, vaccines, adjuvants, and adoptive cell therapies will provide significant future revenue.

Powerful alliances with large-cap biotechs contribute to cash gain.

Technical analysis shows a possible bullish case in the mid- and long-term.

Recently, Agenus, Inc. (NASDAQ:AGEN) was awarded $1 million approximately from the Bill & Melinda Gates Foundation to develop a novel technology for QS-21 production. This grant will focus on an evolving alternative manufacturing process in order to ensure an uninterrupted future supply of QS-21 Stimulon adjuvant. In my view, it is a great opportunity for the company to decrease the cost of production for QS-21 using Python Biotech's technology.

Agenus is an immune-oncology (I-O) company that focuses on the finding and cultivation of therapies that include antibodies, vaccines, and cell therapies. The company was founded in 1994 and was listed on the Nasdaq stock exchange in 2000.

Agenus has had an eventful 2018 with a lot of agreements. Despite the fact that it had a number of good deals, the stock tumbled more than 31 percent from the mid-March and continued that decline through August. During this period, the company had two weak quarterly reports which are below market expectations: -$0.35 actual versus -$0.29 Wall Street estimate (20.69% surprise) in March and -$0.53 actual versus -$0.30 Street estimate (78.65% surprise).

But Agenus beat analyst estimates in August, and shares are up ~30% from the bottom line.

Phase I/II Study Of CTLA-4 AGEN1884 + PD-1 AGEN2034 showed early symptoms of safety and efficacy in phase I and phase II studies. These studies determined that AGEN2034 3mg/kg + AGEN1884 1mg/kg is shown to be safe for a maximum combination dose level.
Early phase I results showed 3 partial responses in patients with cervical, ovarian and breast cancers in the 1-mg/kg and 3-mg/kg groups.

Phase II study included 6 females over 60 years of median age with cervical cancers. In September, a total of 9 patients (3 from phase I and 6 from phase II) had been treated with PD-1.
The summary of Best Overall Response is shown below:

As we can see, the duration of best overall response for each patient is indicated in parentheses. AGEN2034 is a pharmacologically active, well-tolerated PD-1 antagonist, demonstrating early signs of clinical activity in phase I and II portions of the study (2.8 and 1.6 months, respectively) in patients with refractory malignancies.

As for safety and tolerability, this phase I/II studies showed that in patients taking 3-mg/kg PD-1:
No DLTs were reported for any of the patients, and 5 of the 6 patients reported a TEAE. TEAEs occurring in >1 patient included abdominal pain (n=3) and pyrexia (n=2).3 patients experienced a TEAE of grade ≥3, including anemia, international normalized ratio increased, back pain, diarrhea, and abdominal pain. Serious TEAEs occurred in 3 patients, including colitis, abdominal pain, back pain, diarrhea, and pyrexia (n=1 each). The events of diarrhea and colitis were considered related to treatment.1 patient had a TRAE of grade ≥3, which was serious (diarrhea). No TEAEs led to treatment discontinuation or study withdrawal.

By the end of November, Agenus treated more than 130 patients with CTLA-4 and PD-1 Antibodies:
PD-1 (AGEN2034) monotherapy has treated more than 88 evaluable patients with metastatic solid tumors, including 3 out of 7 evaluable patients with cervical cancer, and observed clinical benefit in more than 68% of them.

PD-1 + CTLA-4 (AGEN1884) has treated more than 82 patients with ovarian, breast, and sarcomas and observed clinical benefit in more than 63% of them.

Dr. Anna Wijatyk, Agenus' VP of Clinical Development, met with the FDA and confirmed that PD-1 and CTLA-4 are designed to support a BLA filling as early as 2020. Furthermore, Agenus delivered next-generation CTLA-4 (AGEN1181) in 2018. Thus, on the chance of approval and launch of AGEN1884/AGEN2034, the company will see significant growth in its income and stable source of cash inflows.

Pipeline
The pipeline shows three fully-owned immune modulating antibodies at phase II of development. The company also has fully-owned AutoSynVax at phase I of development, the first-generation individualized vaccine made by combining synthetic versions of each patient's own cancer antigens with heat shock protein 70. Agenus has four more fully-owned candidates at preclinical development.

The company had collaboration with large-cap biotechs. Let's discuss this in detail.
Partnership deals

At the end of December, Agenus announced that it entered to a collaboration with Gilead Sciences (GILD) to develop up to 5 novel immuno-oncology therapies. According to this deal, Gilead will receive worldwide exclusive rights to AGEN1423 - bispecific antibodies are engineered to simultaneously bind two different antigens. Agenus expects that its bispecific program to move into the clinic in 2019. Gilead will also receive the exclusive rights to license two additional programs: AGEN1223 and AGEN2373. In accordance with the agreement, Agenus will receive a $120 million cash payment and $30 million as an equity investment.

GlaxoSmithKline (NYSE:GSK) Vaccines. QS-21 Stimulon is a key component in several GSK vaccines, including shingles vaccine Shingrix, which has demonstrated more than 90 percent efficacy. As a result, Shingrix exceeds all analyst expectations in 2018, and the annual revenue from commercial sales will exceed $600 million in 2018. Furthermore, Agenus recently received a $1 million grant to reduce the cost of QS-21, and in 2019, we could see even more revenue obtained from Shingrix.
Incyte Corp. (NASDAQ:INCY). In 2015 Agenus announced a global license, development and commercialization agreement. The company has five partner programs with Incyte, which focused on accelerating immune attack, blocking immune resistance. According to this agreement, Agenus received $145 million, and for each royalty-bearing product, it will receive up to $155 million. On January 9, 2015, the biotech also entered into Stock Purchase Agreement with Incyte Corp. whereby Incyte purchased approximately 7.76 million shares of Agenus common stock.

Merck Sharp & Dohme (NYSE:MRK). In June 2014, Agenus signed the partnership deal with Merck to develop and optimize therapeutic antibodies. In accordance with the agreement, Agenus received $4 million milestone payment in August 2018 as the company initiated a phase 1 clinical trial.

Financials
As of September 30, 2018, Agenus closed the third quarter with a cash balance of $46 million, which is 68% of the total current assets, total assets of $130.4 million, and total liabilities of $261.867 million.

This implies an assetliability ratio below one. Thus, investors may want to be wary about signs coming from the company's financial situation.

This was a comment that was made by Christine Klaskin, who is the VP of Finance of the Agenus:
As you can see from these numbers, we continue to manage our cash prudently ending this quarter as we projected with a cash balance above that of the end of the second quarter.

The company had an accumulated deficit of $1.1 billion since its inception and successfully financed operations through the sale of equity, notes, corporation partnerships, and interest income. Important to note that on October 10, 2018, Agenus entered into a Stock Purchase Agreement and sold 18,459 convertible preferred shares at a purchase price of $2,167 per share and received $39.9 million in cash (10-Q filling, page 5, 22). On the other hand, in the long-term, that policy has increased the company's debt and required more cash in the future as the loss of early extinguishment of debt was $10.8 million for the nine months ended September 30, 2018, according to the Note Purchase agreement with Oberland Capital SA Zermatt LLC dated September 4, 2015. Also, for the nine months ended 2018, repayment of the debt has made up approximately 65% of the cash flow from financing activities.

As you can see below, a significant amount of cash was used in operating activities, an average of ~68%. R&D expense made up approximately 74% of the operating expenses, which will be used to fund the company's unique pipeline portfolio.

As seen above, for the three months ended September 30, 2018, the total loss reported was equal to $26.07 million, but with the new SPA cash, Agenus believed that it would be enough to fund its pipeline into Q2 of 2019. With total assets of $130.4 million and cash on hand from the most recent partnership deal, the company seems to have enough liquidity to finance its operation for a few years without the need for a new cash inflow. In the third quarter, the biotech has recognized revenue of $13 million, which includes a milestone achievement of $6 million from research and development under collaboration with Incyte and $0.3 million earned from the amortization of deferred revenue. Also, $6.5 million was recognized from a royalty purchase agreement according to which the biotech sold 100% of its worldwide rights to GSK. Keep in mind that the commercial sales of Shingrix beat forecasts, and this implies a high probability of possible revenue increase in Q4.

Technical outlook
The weekly chart below shows the price of AGEN, currently located at the highest level within the borders of the upward channel. This is above the original resistance seen at the $3.00 price level. This is the same place where the price originally found support in April 2016.

AGEN Weekly Chart: 1/10/2019 (Source: Tradingview)
To get a picture of what is going on with AGEN, we turn to the daily chart. As seen in the chart below, the price has set a higher adjusted close within the area of the upward channel. The price has tested $3.00 area several times over the course of the last month and broke it out a few days ago. This implies a possible rally to the $5.00 level from here.

AGEN Daily Chart: 1/10/2019 (Source: Tradingview)
In the chart above, we can see the following implications:
Price has tested the upper channel limit and broke out the resistance level of $3.00
The MACD is rising (bullish signal)
The shares are above 200ma and found strong support at the 50ma
As seen in the table below, the call option with the price strike of $3.00 that expires on January 18, 2019, rises in price by 66%, and the call option with the strike price of $4.00 that expires on the same date rises in price by 150%.

Conclusion
The mid-term and long-term market sentiment for AGEN is bullish because the price has crossed the strong resistance level of $3.00, and we enter into a long-term bullish trend. We expect the company to continue to develop its collaborations with Gilead and others in order to be eligible to receive more fees and milestone payments. The stock has enormous growth drivers as the company develops its oncology pipeline with solid future growth potential.

https://seekingalpha.com/article/4232871-agenus-gets-grant-g…

[xylophon]

Sie fällt und fällt....

[xylophon]

Antwort auf Beitrag Nr.: 61.207.076 von xylophon am 08.08.19 13:56:17

kaum schreib ich es, steigt sie um 20 % an einem Tag.

[Shanghai2006]

First QS-21 Royalty Payment Due to Agenus is Triggered
Dienstag, 10.03.2020 14:15 von PR Newswire

LEXINGTON, Mass., March 10, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, announced the triggering of a $15.1M milestone payment from HealthCare Royalty Partners (HCR) based on net sales of GlaxoSmithKline's (GSK's) Shingrix vaccine exceeding $2.0B in 2019.

Agenus' proprietary QS-21 Stimulon™ is one of the most potent adjuvants known and is a key component in GSK's Shingrix vaccine, which has generated blockbuster sales exceeding $2.3Bn in its second year after launch. Agenus is due another milestone amounting to $25.5M if Shingrix net sales exceed $2.75B over four consecutive quarters before 2026.

[Shanghai2006]

Agenus focuses on its lead PD-1 and CTLA-4 programs, its AGEN1181 breakthrough potential
antibody and therapeutic strategies for COVID-19 by leveraging its capabilities

$50M in expected cost savings by streamlining its operations

Next gen CTLA-4 (AGEN1181) trial is deemed as “potentially life-saving treatment” and continues to enroll patients at an impressive pace AGEN1181 has yielded early exciting results at low doses as
both monotherapy and in combination with balistilimab for patients with late stage cancers. Our principal investigators have informed Agenus that based on the potential life-saving attributes of AGEN1181, they expect to continue to accrue amidst the COVID-19 crisis, which has converted many of America’s major hospitals into “COVID exclusive” medical centers. Our study is recruiting patients
at multiple major academic cancer centers with deep clinical trial and crisis management experience.
AGEN1181 was designed to 1) Improve efficacy vs. 1st gen CTLA-4 agents and 2) Broaden the population of responders. We are seeing early clinical signals.
As previously reported, we have seen responses with AGEN1181 as monotherapy or in combination with balstilimab. Importantly, other cases of objective responses seem to be emerging less than 3 months after we initiated the combination study. Earlier, we reported a complete responder to AGEN1181 monotherapy in MSSendometrial cancer. Based on this and a number of other immune prognostic factors, this patient was unlikely to respond to IO therapies. She was PD-L1 negative, had a genetic polymorphism that renders patients unlikely to respond to 1st generation anti CTLA-4s such as Yervoy, in addition to her microsatellite stable (MSS) status. So far, the majority of evaluable patients in our trial have experienced disease stabilization after having progressed on prior treatments

https://agenusbio.com/wp-content/uploads/2020/04/NL-200407-C…

[Malecon]

Versucht gerade den Ausbruch:

[BrokenOob]

Ist noch jemand investiert? Hier ist ja seit einer Ewigkeit nichts mehr gepostet worden Der Kurs ist zur Zeit aber auch eher ausbaufähig...

[hansdorn]

Antwort auf Beitrag Nr.: 67.774.829 von BrokenOob am 12.04.21 09:50:50

Ich bin investiert :-)

Ich denke wenn der PD-1 Hemmer zugelassen wird wird die Marktkapitalisierung schnell über 1 Mrd. steigen weil es einen enormen Bedarf für PD-1 Hemmer (nicht nur auf dem Markt sondern auch in klinischen Studien in Kombination mit anderen Molekülen) gibt. Wenn Agenus in der Lage ist hier ein paar Kooperationen auf die Beine zu stellen können die mit dem PD-1 Hemmer revenue Ihre restlichen Aktivitäten für die nächsten 10 Jahre finanzieren ohne weitere Moleküle auslizensieren zu müssen.

Falls die Zulassung noch 2021 kommt würde ich einen Kurs von etwa 5-6€ ende des Jahres erwarten.

[equinox10]

Agenus and Bristol Myers Squibb Announce Exclusive Global License for Agenus’ Anti-TIGIT Bispecific Antibody Program

https://investor.agenusbio.com/news-releases/news-release-de…


May 18, 2021

Agenus to receive a $200 million upfront payment and up to $1.36 billion in milestone payments



Kurs reagiert...