Sellas Life Sciences Group (ehemals Galena Biopharma) (Seite 207)
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Galena Biopharma to Present at the 14th Annual Needham Healthcare Conference (Am 14.04 in The Westin H. in New York City)
http://finance.yahoo.com/news/galena-biopharma-present-14th-…
http://finance.yahoo.com/news/galena-biopharma-present-14th-…
Antwort auf Beitrag Nr.: 49.459.958 von Growth2012 am 30.03.15 23:02:24Growth schöner Artikel
hier was mir daraus augen
fällig wurde:
Immunotherapy development currently tends to focus broadly on three treatment categories: chimeric antigen receptor (Car) T-cell therapies, vaccines, and checkpoint blockade strategies. Car therapies, which coat the patient’s T cells to help those cells recognize tumor antigens, remain largely untested against breast cancer, so Mittendorf focused on vaccines and checkpoint inhibitors.
bei CART Technologie soll MGNX stark sein
Vaccine Leads Field
For patients with breast cancer, the most advanced vaccine is nelipepimut-S (neuvax). The formulation is a peptide derived from HER2 protein, combined with the immunoadjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF). Patients receive it monthly for 6 months and then every 6 months thereafter for up to 3 years.
In a phase I/II trial as adjuvant therapy on 187 women with node-positive and high-risk node-negative tumors that expressed any degree of HER2, the 5-year rate of disease-free survival (DFS) was 89.7% overall for those who received the vaccine compared with 80.2% for unvaccinated women.1 For optimally dosed patients, the DFS rate rose to 94.6%.
The phase III PRESENT trial now under way seeks to randomize 700 women with early-stage, node-positive breast cancer with low to intermediate HER2 expression (HER2 1+ by IHC or HER2 2+ by IHC/FISH) to NeuVax or an active comparator composed of the GM-CSF sargramostim (Leukine).2 To be eligible for the trial, patients must have primary tumor stage T1-3 at initial diagnosis that was completely excised through surgery or are receiving neoadjuvant therapy before surgery.
mit Spannung erwartet
“Vaccination takes months to produce an immune response, so it’s probably not an appropriate treatment strategy for very late-stage cancers, but it appears to be particularly appropriate in an adjuvant setting,” said Mittendorf, who has been leading the nelipepimut-S trials.
Impfungen sind im akuten Stadium weniger wirksam, frühzeitige Behandlung wichtig (ähnlich Grippe Impfung)
“At that point, when most patients are already disease-free, harsh treatments make no sense. The tradeoff between toxicity and benefit is not in the patient’s favor. Effective vaccines, on the other hand, make perfect sense because they rarely subject patients to anything worse than mild pain or itching at the injection site. NeuVax is no more grueling than a flu shot.”
Nebewirkungen wie ne Grippeimpfung
There is also reason to think that many vaccines will prove more effective in the adjuvant setting than they have, to date, in the advanced-disease setting. Vaccines against infectious diseases rank among the most beneficial tools created by medical science, but they have a major limitation. They’re far better at prevention than treatment. In general, the more a patient already suffers from the target disease at the time of vaccination, the less a vaccine helps the patient.
“We don’t know enough yet to make blanket statements about the optimal timing for different immunotherapies, but anecdotal evidence suggests that vaccines are less effective in patients with advanced metastatic cancer,” Mittendorf said. “It would explain why many of the earliest vaccine trials, which enrolled patients with diffusely metastatic tumors, failed to demonstrate benefit.
“Timing, in general, is critical in oncology, and it may prove particularly important with immunotherapy,” she said. “Research needs to demonstrate not only whether treatments work but when and how they work the best so that clinicians can prescribe each patient the right treatment at the right time.” - See more at: http://www.onclive.com/web-exclusives/Hope-Rises-for-Immunot…
Timing ist sehr wichtig
Gruss S.
hier was mir daraus augen
fällig wurde:Immunotherapy development currently tends to focus broadly on three treatment categories: chimeric antigen receptor (Car) T-cell therapies, vaccines, and checkpoint blockade strategies. Car therapies, which coat the patient’s T cells to help those cells recognize tumor antigens, remain largely untested against breast cancer, so Mittendorf focused on vaccines and checkpoint inhibitors.
bei CART Technologie soll MGNX stark sein
Vaccine Leads Field
For patients with breast cancer, the most advanced vaccine is nelipepimut-S (neuvax). The formulation is a peptide derived from HER2 protein, combined with the immunoadjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF). Patients receive it monthly for 6 months and then every 6 months thereafter for up to 3 years.
In a phase I/II trial as adjuvant therapy on 187 women with node-positive and high-risk node-negative tumors that expressed any degree of HER2, the 5-year rate of disease-free survival (DFS) was 89.7% overall for those who received the vaccine compared with 80.2% for unvaccinated women.1 For optimally dosed patients, the DFS rate rose to 94.6%.
The phase III PRESENT trial now under way seeks to randomize 700 women with early-stage, node-positive breast cancer with low to intermediate HER2 expression (HER2 1+ by IHC or HER2 2+ by IHC/FISH) to NeuVax or an active comparator composed of the GM-CSF sargramostim (Leukine).2 To be eligible for the trial, patients must have primary tumor stage T1-3 at initial diagnosis that was completely excised through surgery or are receiving neoadjuvant therapy before surgery.
mit Spannung erwartet
“Vaccination takes months to produce an immune response, so it’s probably not an appropriate treatment strategy for very late-stage cancers, but it appears to be particularly appropriate in an adjuvant setting,” said Mittendorf, who has been leading the nelipepimut-S trials.
Impfungen sind im akuten Stadium weniger wirksam, frühzeitige Behandlung wichtig (ähnlich Grippe Impfung)
“At that point, when most patients are already disease-free, harsh treatments make no sense. The tradeoff between toxicity and benefit is not in the patient’s favor. Effective vaccines, on the other hand, make perfect sense because they rarely subject patients to anything worse than mild pain or itching at the injection site. NeuVax is no more grueling than a flu shot.”
Nebewirkungen wie ne Grippeimpfung
There is also reason to think that many vaccines will prove more effective in the adjuvant setting than they have, to date, in the advanced-disease setting. Vaccines against infectious diseases rank among the most beneficial tools created by medical science, but they have a major limitation. They’re far better at prevention than treatment. In general, the more a patient already suffers from the target disease at the time of vaccination, the less a vaccine helps the patient.
“We don’t know enough yet to make blanket statements about the optimal timing for different immunotherapies, but anecdotal evidence suggests that vaccines are less effective in patients with advanced metastatic cancer,” Mittendorf said. “It would explain why many of the earliest vaccine trials, which enrolled patients with diffusely metastatic tumors, failed to demonstrate benefit.
“Timing, in general, is critical in oncology, and it may prove particularly important with immunotherapy,” she said. “Research needs to demonstrate not only whether treatments work but when and how they work the best so that clinicians can prescribe each patient the right treatment at the right time.” - See more at: http://www.onclive.com/web-exclusives/Hope-Rises-for-Immunot…
Timing ist sehr wichtig
Gruss S.
Antwort auf Beitrag Nr.: 49.459.958 von Growth2012 am 30.03.15 23:02:24and I quote...
In a phase I/II trial as adjuvant therapy on 187 women with node-positive and high-risk node-negative tumors that expressed any degree of HER2, the 5-year rate of disease-free survival (DFS) was 89.7% overall for those who received the vaccine compared with 80.2% for unvaccinated women.1 For optimally dosed patients, the DFS rate rose to 94.6%.
In a phase I/II trial as adjuvant therapy on 187 women with node-positive and high-risk node-negative tumors that expressed any degree of HER2, the 5-year rate of disease-free survival (DFS) was 89.7% overall for those who received the vaccine compared with 80.2% for unvaccinated women.1 For optimally dosed patients, the DFS rate rose to 94.6%.
Very interesting article re Dr. Elizabeth Mittendorp (etwas Ernst die Dame, aber dafür die letzte Instanz im sachen Breast Cancer Research, inkl. Neuvax's mögliche Anwendungsgebiet(e)...
Hope Rises for Immunotherapy in Breast Cancer
http://www.onclive.com/web-exclusives/Hope-Rises-for-Immunot…
...hope rises indeed
(1,40$ zurzeit and counting)
Hope Rises for Immunotherapy in Breast Cancer
http://www.onclive.com/web-exclusives/Hope-Rises-for-Immunot…
...hope rises indeed
(1,40$ zurzeit and counting)
Antwort auf Beitrag Nr.: 49.452.101 von Schaeffi am 30.03.15 08:29:37Hi Schaeffi, ich warte nicht mehr...
habe meine Postion vorhin 'brav' nach oben "abgerundet"
(hier kauft man am tief des sechsmonats verlauf bei bester Aussichten, bald gibts gar kein Grund mehr zum shorten)
und ja, Du hast selbsverständlich Recht, Pharmacyclics war gemeint, werde nur die jeweilige kürzel (PCYC) benutzen ab jetzt
habe meine Postion vorhin 'brav' nach oben "abgerundet"
(hier kauft man am tief des sechsmonats verlauf bei bester Aussichten, bald gibts gar kein Grund mehr zum shorten) und ja, Du hast selbsverständlich Recht, Pharmacyclics war gemeint, werde nur die jeweilige kürzel (PCYC) benutzen ab jetzt
Trading Spotlight
Antwort auf Beitrag Nr.: 49.451.189 von Schaeffi am 29.03.15 21:54:24NK zu 1,267 EUR
mal sehen obs noch billiger wird
mal sehen obs noch billiger wird
Antwort auf Beitrag Nr.: 49.448.927 von Growth2012 am 29.03.15 11:03:24
wenn du Pharmacyclics, Inc.
$256.555
meinst!
kenn ich
gibt es aber schon viel länger und wurde kürzlich von Abbvie für lächerliche 21MRD USD gekauft
http://www.reuters.com/article/2015/03/05/us-pharmacyclics-m…
bei Gale wäre ich mit etwas weniger auch schon zufrieden
Gruss S.
Zitat von Growth2012: Kennst du Pharmalytics? (erst seit Anfang 2014 am Markt, mit ca.76 Mio shares im Umlauf) um GALE's Potential annährend erahnen zu können, siehe die 6 Monats Chartverlauf von PCYC und das passende Yahoo Posting bzgl. seine Marktstellung anbei- nough said!
wenn du Pharmacyclics, Inc.
$256.555
meinst!
kenn ich
gibt es aber schon viel länger und wurde kürzlich von Abbvie für lächerliche 21MRD USD gekauft
http://www.reuters.com/article/2015/03/05/us-pharmacyclics-m…
bei Gale wäre ich mit etwas weniger auch schon zufrieden
Gruss S.
evtl. auch Erwähnenswert in Bezug auf Neuvax's MK Potential...
Using risk-adjusted net present value method (rNPV).
Expected start of sales = 2019, and patent good to 2028 = 9 years of sales
Starting with conservative estimate that Neuvax gross sales will equal Herceptin's sales over first 9 years = $7.722B.
Adjusted for cost of sales (60%) and royalties (5% to MDACC) = $7.722B x .35 = $2.703B net.
Adjusting for R&D risk: 35% chance of phase 3 success (average for oncology drugs) x 90% of FDA approval =31.5% chance to make it to market. $2.703B x .315 = $851.6M risk adjusted payoff.
Risk adjusted cost of remaining development:
$6M/quarter (PRESENT trial only) x 12 remaining quarters (end of 2017) = $72M.
current debt =$9M
$72M + $9M = $81M risk-adjusted cost.
Risk-adjusted payoff - risk-adjusted cost = $851.6M - $81M = $770.6M
Add present cash on hand of $59.4M, $770.6M + $59.4M = $830M present value of Neuvax.
Neuvax contribution to price per share:
$830M/156M shares outstanding = $5.32/share.
Add onto this the rNPV for FBP, Anegralide CR, the rest of the Neuvax franchise + expected sales for Abstral and Zuplenz and I'll bet the real value is closer to $8/share.
Note: I believe the chance for phase 3 success is more like 85% to 90% - much higher than the conservative 35% I used in the calculation.
...food for thought (je nach Anlage Horizont)
Using risk-adjusted net present value method (rNPV).
Expected start of sales = 2019, and patent good to 2028 = 9 years of sales
Starting with conservative estimate that Neuvax gross sales will equal Herceptin's sales over first 9 years = $7.722B.
Adjusted for cost of sales (60%) and royalties (5% to MDACC) = $7.722B x .35 = $2.703B net.
Adjusting for R&D risk: 35% chance of phase 3 success (average for oncology drugs) x 90% of FDA approval =31.5% chance to make it to market. $2.703B x .315 = $851.6M risk adjusted payoff.
Risk adjusted cost of remaining development:
$6M/quarter (PRESENT trial only) x 12 remaining quarters (end of 2017) = $72M.
current debt =$9M
$72M + $9M = $81M risk-adjusted cost.
Risk-adjusted payoff - risk-adjusted cost = $851.6M - $81M = $770.6M
Add present cash on hand of $59.4M, $770.6M + $59.4M = $830M present value of Neuvax.
Neuvax contribution to price per share:
$830M/156M shares outstanding = $5.32/share.
Add onto this the rNPV for FBP, Anegralide CR, the rest of the Neuvax franchise + expected sales for Abstral and Zuplenz and I'll bet the real value is closer to $8/share.
Note: I believe the chance for phase 3 success is more like 85% to 90% - much higher than the conservative 35% I used in the calculation.
...food for thought
(je nach Anlage Horizont)
Antwort auf Beitrag Nr.: 49.436.474 von Schaeffi am 27.03.15 08:51:17Hi Schaeffi, sehe ich genauso, der Shareprice wird definitiv "künstlich" runtergehalten zurzeit, die Deckelung wird allerdings nicht mehr lange bestand halten können (siehe after hours Freitag), man spricht sogar von Takeover Avancen von/durch TEVA aus Israel:- we will know more in time
Kennst du Pharmalytics? (erst seit Anfang 2014 am Markt, mit ca.76 Mio shares im Umlauf) um GALE's Potential annährend erahnen zu können, siehe die 6 Monats Chartverlauf von PCYC und das passende Yahoo Posting bzgl. seine Marktstellung anbei- nough said!
Artificial low - exponential upside
This week rather a very good news come out expending potential market size of already huge market for Neuvax.
Yet- PPS went down from market manipulation. Nothing but a buying opportunity.
Neuvax target adjuvant breast cancer patients- adjuvant breast cancer treatment is the largest segment in oncology world. A typical oncologist will prescribe adjuvant treatment for breast cancer in any week more than any other cancer. Neuvax is not a cancer treatment for relatively rarer cancer such as thyroid cancer or brain cancer. It's market potential is unbelievably huge- many people fail to understand that enormous potential.
PCYC address lymphomas- and see what happen to its PPS. Breast adjuvant treatment market is much larger than that.
http://finance.yahoo.com/mbview/threadview/;_ylt=AmAla8UFlnf…
Kennst du Pharmalytics? (erst seit Anfang 2014 am Markt, mit ca.76 Mio shares im Umlauf) um GALE's Potential annährend erahnen zu können, siehe die 6 Monats Chartverlauf von PCYC und das passende Yahoo Posting bzgl. seine Marktstellung anbei- nough said!
Artificial low - exponential upside
This week rather a very good news come out expending potential market size of already huge market for Neuvax.
Yet- PPS went down from market manipulation. Nothing but a buying opportunity.
Neuvax target adjuvant breast cancer patients- adjuvant breast cancer treatment is the largest segment in oncology world. A typical oncologist will prescribe adjuvant treatment for breast cancer in any week more than any other cancer. Neuvax is not a cancer treatment for relatively rarer cancer such as thyroid cancer or brain cancer. It's market potential is unbelievably huge- many people fail to understand that enormous potential.
PCYC address lymphomas- and see what happen to its PPS. Breast adjuvant treatment market is much larger than that.
http://finance.yahoo.com/mbview/threadview/;_ylt=AmAla8UFlnf…
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