Endocyte - mit small molecule drug conjugates gegen Krebs - 500 Beiträge pro Seite
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Feedback
Am 04.02.2011 hatten Endocyte ihren IPO.
Die Aktie notiert unter dem Tickersymbol ECYT.
Ich denke, dass es sich hier um ein interessantes Unternehmen handelt, weil es über eine Plattformtechnologie verfügt, die einen neuartigen Ansatz bei der Wirkstoffentwicklung darstellt.
Das Grundprinzip ist aus dem Antikörperbereich bereits bekannt und wird dort als ADC (antibody drug conjugate) bezeichnet. Technologieanbieter sind dort insbesondere Seattle Genetics und Immunogen.
Endocyte verfolgt letztlich das selbe Konzept, nur eben auf der Basis von small molecules als "Fähren".
Einige Grunddaten:
IPO zu 6,00 USD
Kurs derzeit ca. 7,50 USD
Aktienzahl ca. 29,5 Mio. Stück (nach Mehrzuteilung)
Marktkapitalisierung ca. 221 Mio. USD
Pipeline:
Grundlegendes zur Technologieplattform:
Targeting Ligand .
Our technology is founded on our high-affinity small molecule ligands that bind to
over-expressed receptors on target cells, while largely avoiding healthy cells. We are developing a number
of targeting ligands to address a broad range of cancers and inflammatory diseases.
Linker System .
Our linker system attaches the targeting ligand to the drug payload or imaging agent.
It is designed to be stable in the bloodstream, and to release the active drug from the targeting ligand when
the SMDC is taken up by the diseased cell. The linker system can be customized for each SMDC and each
companion imaging diagnostic to improve its pharmacologic properties.
Drug Payload .
This module is the biologically active component of our SMDCs. The majority of our
drug payloads are highly active molecules that are too toxic to be administered in their untargeted forms at
therapeutic dose levels. We are using drug payloads in our SMDCs that were shown in our in vitro
preclinical studies to be between 10,000 and 100,000 times more potent than traditional cancer cell-killing
drugs such as cisplatin.
Das Lead-Programm EC145 beginnt demnächst die P III und hat in der P II bei Eierstockkrebs hoffnungsvolle Daten geliefert:
Our lead SMDC, EC145, targets the folate receptor, which is frequently over-expressed in some
of the most prevalent, and difficult to treat solid tumor indications, including ovarian, non-small cell
lung, breast, colorectal, kidney, endometrial and other cancers. We identify the presence of the folate
receptor in cancer patients by using EC20, our proprietary companion imaging diagnostic for
EC145. We have chosen platinum-resistant ovarian cancer, or PROC, a highly treatment-resistant
disease, as our lead indication for development of EC145 because of the high unmet need in treating
this patient population and the high percentage of ovarian cancer patients whose tumors over-express
the targeted folate receptor. In the final progression free survival, or PFS, analysis of PRECEDENT,
our randomized phase 2 clinical trial in women with PROC, EC145 increased PFS from a median of
11.7 weeks to a median of 21.7 weeks, representing an 85 percent improvement over standard
therapy (p=0.031). The “p” represents p-value, which is the probability that the difference observed
between the treatment arm and the control arm is due to chance, in this case 3.1 percent. We studied
a subset of patients in which 100 percent of their target lesions over-expressed the folate receptor as
determined by an EC20 scan, which patients we refer to as EC20(++). We treated these EC20(++)
patients with a combination of EC145 and PLD and observed a median PFS of 24.0 weeks compared
to a median of 6.6 weeks for patients receiving PLD alone, an improvement of over 260 percent. The
hazard ratio was 0.381 (p=0.018), or a reduction in the risk of progression of 61.9 percent. We
anticipate beginning enrollment in PROCEED, our phase 3 registration trial for EC145, in the first
half of 2011.
-------------------
EC145 wird auch in der Indikation Lungenkrebs getestet, was insbesondere kommerziell sehr attraktiv sein könnte.
Die zugrunde liegende Technologie ist aus zwei Gründen besonders interessant:
Zum einen durch die Kombination der "Fähren" mit diagnostischen Markern, was eine echte personalisierte Behandlung mit höheren Erfolgschancen verspricht:
Our technology allows us to create companion imaging diagnostics intended for use with each of our SMDCs. To create our companion imaging diagnostics, we replace the drug payload of the SMDC with an imaging agent that is easily seen with widely available nuclear imaging equipment. Because the targeting ligand found on the companion imaging diagnostic is identical to that found on the therapeutic SMDC, our companion imaging diagnostics allow us to obtain full-body real-time images of tumors that over-express the target for that particular SMDC.
Zum anderen, weil die Fähre mit einem Toxin beladen wird (wie bei einem ADC):
The majority of our drug payloads are highly active molecules that are too toxic to be administered in their untargeted forms at therapeutic dose levels. We are using drug payloads in our SMDCs that were shown in our in-vitro preclinical studies to be between 10,000 and 100,000 times more highly active than traditional cancer cell-killing drugs such as cisplatin.
Dabei wird behauptet, dass die Technologie von Endocyte, nämlich Linker und Toxin auf ein small molecule aufzusetzen, gegenüber ADCs Vorteile biete:
• Small size to better penetrate solid tumors. We believe a key characteristic of our SMDCs is their
ability to penetrate deeply into dense solid tumors. The targeting ligands for our SMDCs are
approximately 300 times smaller in molecular weight than a typical antibody incorporated in ADCs.
This may result in greater uptake and higher concentrations of these molecules within solid tumors.
• Rapid clearance for reduced toxicity. The circulating half-life of ADCs currently in development
generally range from several hours to several days. In contrast, our SMDCs are engineered to provide rapid uptake in targeted cells and rapid clearance from the bloodstream with a half-life of
approximately 20 minutes. As a result of this shorter half-life, we believe there is reduced risk that
our SMDCs will release the unconjugated drug payload into the blood stream. In our phase 1 trial of
EC145, only four of 410, or less than one percent, of the blood samples analyzed had quantifiable
levels of the unconjugated drug payload, and all four of these positive samples had concentrations
near the lowest level of detection, and at a level where no significant toxicity was found.
• Companion imaging diagnostics for targeted therapy. A companion imaging diagnostic can be
created for each of our SMDCs. Because of the modular nature of our SMDC technology, the drug
payload can be replaced with a radioisotope imaging agent, such as technetium-99m, or
Tc-99m, that we employ in EC20, to create a companion imaging diagnostic designed to target the
same diseased cells as the SMDC. The companion imaging diagnostic is intended to allow for realtime,
full-body assessment of the receptor target without requiring an invasive tissue biopsy. Using
full-body imaging, the receptor expression can be measured in every tumor and monitored
throughout treatment. In our clinical trials that combined EC145 with EC20, we have seen
correlations between favorable therapeutic outcomes and increased uptake of EC20.
• Cost-effective and simple to manufacture. Given the increasing pressure on drug pricing posed by
payors, costs of development and manufacturing are increasingly important. Our SMDCs are
relatively simple to manufacture and do not have the complexity and expense of biological
molecules, like antibodies and ADCs.
-----------------
Fazit:
Wer sich für ADCs interessiert, sollte auch Endocyte zumindest im Blick behalten. Es ist ein verwandter Ansatz auf anderer Basis, was an sich schon interessant ist.
Negativ fällt bisher eigentlich "nur" auf, dass sie keine Partner im Boot haben. Das wirft natürlich Fragen auf...
----------
PS: Habe am IPO-Tag für 6,60 USD eine erste Position gekauft.
Die Aktie notiert unter dem Tickersymbol ECYT.
Ich denke, dass es sich hier um ein interessantes Unternehmen handelt, weil es über eine Plattformtechnologie verfügt, die einen neuartigen Ansatz bei der Wirkstoffentwicklung darstellt.
Das Grundprinzip ist aus dem Antikörperbereich bereits bekannt und wird dort als ADC (antibody drug conjugate) bezeichnet. Technologieanbieter sind dort insbesondere Seattle Genetics und Immunogen.
Endocyte verfolgt letztlich das selbe Konzept, nur eben auf der Basis von small molecules als "Fähren".
Einige Grunddaten:
IPO zu 6,00 USD
Kurs derzeit ca. 7,50 USD
Aktienzahl ca. 29,5 Mio. Stück (nach Mehrzuteilung)
Marktkapitalisierung ca. 221 Mio. USD
Pipeline:
Grundlegendes zur Technologieplattform:
Targeting Ligand .
Our technology is founded on our high-affinity small molecule ligands that bind to
over-expressed receptors on target cells, while largely avoiding healthy cells. We are developing a number
of targeting ligands to address a broad range of cancers and inflammatory diseases.
Linker System .
Our linker system attaches the targeting ligand to the drug payload or imaging agent.
It is designed to be stable in the bloodstream, and to release the active drug from the targeting ligand when
the SMDC is taken up by the diseased cell. The linker system can be customized for each SMDC and each
companion imaging diagnostic to improve its pharmacologic properties.
Drug Payload .
This module is the biologically active component of our SMDCs. The majority of our
drug payloads are highly active molecules that are too toxic to be administered in their untargeted forms at
therapeutic dose levels. We are using drug payloads in our SMDCs that were shown in our in vitro
preclinical studies to be between 10,000 and 100,000 times more potent than traditional cancer cell-killing
drugs such as cisplatin.
Das Lead-Programm EC145 beginnt demnächst die P III und hat in der P II bei Eierstockkrebs hoffnungsvolle Daten geliefert:
Our lead SMDC, EC145, targets the folate receptor, which is frequently over-expressed in some
of the most prevalent, and difficult to treat solid tumor indications, including ovarian, non-small cell
lung, breast, colorectal, kidney, endometrial and other cancers. We identify the presence of the folate
receptor in cancer patients by using EC20, our proprietary companion imaging diagnostic for
EC145. We have chosen platinum-resistant ovarian cancer, or PROC, a highly treatment-resistant
disease, as our lead indication for development of EC145 because of the high unmet need in treating
this patient population and the high percentage of ovarian cancer patients whose tumors over-express
the targeted folate receptor. In the final progression free survival, or PFS, analysis of PRECEDENT,
our randomized phase 2 clinical trial in women with PROC, EC145 increased PFS from a median of
11.7 weeks to a median of 21.7 weeks, representing an 85 percent improvement over standard
therapy (p=0.031). The “p” represents p-value, which is the probability that the difference observed
between the treatment arm and the control arm is due to chance, in this case 3.1 percent. We studied
a subset of patients in which 100 percent of their target lesions over-expressed the folate receptor as
determined by an EC20 scan, which patients we refer to as EC20(++). We treated these EC20(++)
patients with a combination of EC145 and PLD and observed a median PFS of 24.0 weeks compared
to a median of 6.6 weeks for patients receiving PLD alone, an improvement of over 260 percent. The
hazard ratio was 0.381 (p=0.018), or a reduction in the risk of progression of 61.9 percent. We
anticipate beginning enrollment in PROCEED, our phase 3 registration trial for EC145, in the first
half of 2011.
-------------------
EC145 wird auch in der Indikation Lungenkrebs getestet, was insbesondere kommerziell sehr attraktiv sein könnte.
Die zugrunde liegende Technologie ist aus zwei Gründen besonders interessant:
Zum einen durch die Kombination der "Fähren" mit diagnostischen Markern, was eine echte personalisierte Behandlung mit höheren Erfolgschancen verspricht:
Our technology allows us to create companion imaging diagnostics intended for use with each of our SMDCs. To create our companion imaging diagnostics, we replace the drug payload of the SMDC with an imaging agent that is easily seen with widely available nuclear imaging equipment. Because the targeting ligand found on the companion imaging diagnostic is identical to that found on the therapeutic SMDC, our companion imaging diagnostics allow us to obtain full-body real-time images of tumors that over-express the target for that particular SMDC.
Zum anderen, weil die Fähre mit einem Toxin beladen wird (wie bei einem ADC):
The majority of our drug payloads are highly active molecules that are too toxic to be administered in their untargeted forms at therapeutic dose levels. We are using drug payloads in our SMDCs that were shown in our in-vitro preclinical studies to be between 10,000 and 100,000 times more highly active than traditional cancer cell-killing drugs such as cisplatin.
Dabei wird behauptet, dass die Technologie von Endocyte, nämlich Linker und Toxin auf ein small molecule aufzusetzen, gegenüber ADCs Vorteile biete:
• Small size to better penetrate solid tumors. We believe a key characteristic of our SMDCs is their
ability to penetrate deeply into dense solid tumors. The targeting ligands for our SMDCs are
approximately 300 times smaller in molecular weight than a typical antibody incorporated in ADCs.
This may result in greater uptake and higher concentrations of these molecules within solid tumors.
• Rapid clearance for reduced toxicity. The circulating half-life of ADCs currently in development
generally range from several hours to several days. In contrast, our SMDCs are engineered to provide rapid uptake in targeted cells and rapid clearance from the bloodstream with a half-life of
approximately 20 minutes. As a result of this shorter half-life, we believe there is reduced risk that
our SMDCs will release the unconjugated drug payload into the blood stream. In our phase 1 trial of
EC145, only four of 410, or less than one percent, of the blood samples analyzed had quantifiable
levels of the unconjugated drug payload, and all four of these positive samples had concentrations
near the lowest level of detection, and at a level where no significant toxicity was found.
• Companion imaging diagnostics for targeted therapy. A companion imaging diagnostic can be
created for each of our SMDCs. Because of the modular nature of our SMDC technology, the drug
payload can be replaced with a radioisotope imaging agent, such as technetium-99m, or
Tc-99m, that we employ in EC20, to create a companion imaging diagnostic designed to target the
same diseased cells as the SMDC. The companion imaging diagnostic is intended to allow for realtime,
full-body assessment of the receptor target without requiring an invasive tissue biopsy. Using
full-body imaging, the receptor expression can be measured in every tumor and monitored
throughout treatment. In our clinical trials that combined EC145 with EC20, we have seen
correlations between favorable therapeutic outcomes and increased uptake of EC20.
• Cost-effective and simple to manufacture. Given the increasing pressure on drug pricing posed by
payors, costs of development and manufacturing are increasingly important. Our SMDCs are
relatively simple to manufacture and do not have the complexity and expense of biological
molecules, like antibodies and ADCs.
-----------------
Fazit:
Wer sich für ADCs interessiert, sollte auch Endocyte zumindest im Blick behalten. Es ist ein verwandter Ansatz auf anderer Basis, was an sich schon interessant ist.
Negativ fällt bisher eigentlich "nur" auf, dass sie keine Partner im Boot haben. Das wirft natürlich Fragen auf...
----------
PS: Habe am IPO-Tag für 6,60 USD eine erste Position gekauft.
Das IPO ist nunmehr einschließlich der Mehrzuteilung abgeschlossen und hat ca. 79 Mio. USD eingebracht.
Damit kann die P III für EC145 angegangen werden. Indes werden diese Mittel wohl kaum ausreichen, um diesen Trial abzuschließen (wahrscheinlich 2013).
Spannend wird die Frage sein, ob Endocyte dieses Programm verpartnern kann. Die Rechte außerhalb US dürften zu haben sein...
WEST LAFAYETTE, Ind., Feb. 9, 2011 (GLOBE NEWSWIRE) -- Endocyte, Inc., (Nasdaq:ECYT - News), a biopharmaceutical company developing targeted small molecule drug conjugates and companion imaging diagnostics for personalized therapy, announced today the closing of its initial public offering of 14,375,000 shares of common stock (including 1,875,000 shares of common stock pursuant to the exercise of the over-allotment option by the underwriters). The net proceeds to Endocyte from the initial public offering are $78.8 million. Endocyte intends to utilize these cash resources to fund its phase 3 clinical trial related to the use of EC145 and EC20 in platinum-resistant ovarian cancer and to move preclinical products forward in the development process.
Damit kann die P III für EC145 angegangen werden. Indes werden diese Mittel wohl kaum ausreichen, um diesen Trial abzuschließen (wahrscheinlich 2013).
Spannend wird die Frage sein, ob Endocyte dieses Programm verpartnern kann. Die Rechte außerhalb US dürften zu haben sein...
WEST LAFAYETTE, Ind., Feb. 9, 2011 (GLOBE NEWSWIRE) -- Endocyte, Inc., (Nasdaq:ECYT - News), a biopharmaceutical company developing targeted small molecule drug conjugates and companion imaging diagnostics for personalized therapy, announced today the closing of its initial public offering of 14,375,000 shares of common stock (including 1,875,000 shares of common stock pursuant to the exercise of the over-allotment option by the underwriters). The net proceeds to Endocyte from the initial public offering are $78.8 million. Endocyte intends to utilize these cash resources to fund its phase 3 clinical trial related to the use of EC145 and EC20 in platinum-resistant ovarian cancer and to move preclinical products forward in the development process.
Erwartungsgemäß hat Ohad Hammer Endocyte in sein Portfolio aufgenommen. Leider hat er (noch?) keinen Artikel zum Unternehmen veröffentlicht und ich gehe auch nicht unbedingt davon aus, dass dies noch passieren wird:
http://www.hammerstockblog.com/seattle-genetics-strengthens-…
Die relevanten Auszüge:
...
"But what about cases where an ADC needs to be given in combination? This is still an open question as there is not enough clinical data out there regarding ADCs as part of combination regimens. One encouraging indication comes from Endocyte (ECYT), who is developing small-molecule drug conjugates (SMDC). Although SMDCs have a totally different clinical profile than ADCs, both rely on a similar approach of a targeting moiety used to deliver a toxic payload into cancer cells. Endocyte’s lead agent, EC145, was not effective enough to be given alone, so the company evaluated it in a randomized phase II in combination with chemotherapy. Results demonstrated a remarkable benefit in a subset of patients who expressed EC145’s target in all of their lesions, so this can be viewed as a conceptual proof of concept."
...
"We are selling our positions in Allos (ALTH) and NeurogesX (NGSX). In addition, we are initiating positions in Pharmacyclics (PCYC) and Endocyte, as both companies have wholly owned agents with solid clinical data. With pharma industry constantly looking for advanced stage products with high likelihood of success, both companies could strike lucrative licensing deals during 2011."
http://www.hammerstockblog.com/seattle-genetics-strengthens-…
Die relevanten Auszüge:
...
"But what about cases where an ADC needs to be given in combination? This is still an open question as there is not enough clinical data out there regarding ADCs as part of combination regimens. One encouraging indication comes from Endocyte (ECYT), who is developing small-molecule drug conjugates (SMDC). Although SMDCs have a totally different clinical profile than ADCs, both rely on a similar approach of a targeting moiety used to deliver a toxic payload into cancer cells. Endocyte’s lead agent, EC145, was not effective enough to be given alone, so the company evaluated it in a randomized phase II in combination with chemotherapy. Results demonstrated a remarkable benefit in a subset of patients who expressed EC145’s target in all of their lesions, so this can be viewed as a conceptual proof of concept."
...
"We are selling our positions in Allos (ALTH) and NeurogesX (NGSX). In addition, we are initiating positions in Pharmacyclics (PCYC) and Endocyte, as both companies have wholly owned agents with solid clinical data. With pharma industry constantly looking for advanced stage products with high likelihood of success, both companies could strike lucrative licensing deals during 2011."
Der erste Q-Bericht nach dem IPO sind da.
Ein paar Auszüge:
Total common shares of 29,661,614 were outstanding after the initial public offering.
For the full year 2010, Endocyte reported a net loss of $20.1 million
At December 31, 2010, Endocyte had $16.9 million in cash, cash equivalents and short-term investments. This balance does not include $3.7 million in net proceeds from the second closing of the subordinated promissory note offering or the $78.8 million in net proceeds from the initial public offering, both of which occurred in the first quarter of 2011.
Endocyte expects to end 2011 with more than $60 million in cash, cash equivalents and short term investments. Endocyte expects its current cash position to be sufficient to fund PROCEED, its phase 3 trial of EC145 and EC20, to the primary endpoint anticipated in the second quarter of 2013. The current operating plan does not include the initiation of other significant clinical trials beyond PROCEED. Variability in expenses in 2011 will be mostly influenced by the timing of the PROCEED trial initiation and pace of enrollment.
----------
Für 2011 wird also ein Cashburn von ca. 40 Mio. veranschlagt. Das ist schon ne Menge. Aber mit ner P III kaum anders zu erwarten.
Eine Verpartnerung wäre in den nächsten sagen wir 18 Monaten sehr zu wünschen.
Ein paar Auszüge:
Total common shares of 29,661,614 were outstanding after the initial public offering.
For the full year 2010, Endocyte reported a net loss of $20.1 million
At December 31, 2010, Endocyte had $16.9 million in cash, cash equivalents and short-term investments. This balance does not include $3.7 million in net proceeds from the second closing of the subordinated promissory note offering or the $78.8 million in net proceeds from the initial public offering, both of which occurred in the first quarter of 2011.
Endocyte expects to end 2011 with more than $60 million in cash, cash equivalents and short term investments. Endocyte expects its current cash position to be sufficient to fund PROCEED, its phase 3 trial of EC145 and EC20, to the primary endpoint anticipated in the second quarter of 2013. The current operating plan does not include the initiation of other significant clinical trials beyond PROCEED. Variability in expenses in 2011 will be mostly influenced by the timing of the PROCEED trial initiation and pace of enrollment.
----------
Für 2011 wird also ein Cashburn von ca. 40 Mio. veranschlagt. Das ist schon ne Menge. Aber mit ner P III kaum anders zu erwarten.
Eine Verpartnerung wäre in den nächsten sagen wir 18 Monaten sehr zu wünschen.
Diese Art von Analystenkommentaren nehme ich im Allgemeinen nicht ernst, aber weil er - soweit ich es sehe - der erste überhaupt ist und weil ich den Eindruck habe, dass dieser die Aktie heute nach oben zieht, sei er zitiert:
Robert W. Baird analysts initiated coverage on shares of Endocyte (NASDAQ: ECYT). They set an “outperform” rating and a $15.00 price target on the stock.
Robert W. Baird analysts initiated coverage on shares of Endocyte (NASDAQ: ECYT). They set an “outperform” rating and a $15.00 price target on the stock.
Trading Spotlight
Das kommt jetzt aber sehr überraschend!
Endocyte Announces Intent to Seek Conditional Marketing Authorization in the European Union for Targeted Therapeutic EC145 and Companion Imaging Diagnostic EC20 for Platinum-Resistant Ovarian Cancer
Filings to be Based on Results of Phase 2 PRECEDENT Trial
WEST LAFAYETTE, Ind., April 26, 2011 – Endocyte, Inc., (NASDAQ: ECYT), a
biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced its plan to prepare two marketing authorization applications to the European Medicines Agency (EMA). These two marketing applications are for the company’s lead drug candidate EC145 for the treatment of platinum-resistant ovarian cancer and its companion imaging diagnostic EC20 for patient selection. The filings will be based on the results of the randomized Phase 2 PRECEDENT trial and supported by a Phase 2 single agent EC145 clinical trial.
“We’ve been in consultation with the EMA regarding our PRECEDENT results and the design of our Phase 3 trial, PROCEED,” said Ron Ellis, president and CEO of Endocyte. “As part of this consultation, we explored the possibility of seeking conditional marketing authorization in the EU based on Phase 2 results. As a result of our interaction with the EMA, including a meeting with the Scientific Advice Working Party and written advice from the Committee for Medicinal Products for Human Use (CHMP), we will prepare marketing applications for both EC145 and EC20. The CHMP welcomed the use of EC20 to select patients with the targeted receptor, so we plan to seek conditional marketing authorization in patients with platinum-resistant ovarian cancer who are EC20 positive. We will discuss these developments during our first quarter conference call scheduled for May 5, 2011.”
The PRECEDENT trial, a randomized, multi-center, international Phase 2 study, investigated EC145 in combination with standard chemotherapy, pegylated liposomal doxorubicin (PLD), for treatment of women with platinum-resistant ovarian cancer and evaluated the utility of EC20 for patient selection. The study met its primary endpoint; the combination of EC145 and PLD showed an improvement in the time to disease progression or death compared to PLD alone. This improvement was more substantial in patients who were selected with the companion imaging diagnostic EC20.
Conditional marketing authorization may be granted in certain situations for medical products which treat life-threatening diseases and provide earlier access to patients in areas of high unmet medical need. Conditional marketing authorizations must be renewed annually and require completion of ongoing or new clinical trials to confirm that the risk-benefit balance is positive.
Endocyte cannot predict with any certainty at this time when it will file the marketing applications nor give any assurance that the applications for conditional marketing authorization for either EC145 or the companion imaging diagnostic EC20 will be approved by the EMA.
----------
Ich bin sehr gespannt, wie das ausgeht! Wenn sich die EMA darauf einlässt, käme der Ritterschlag für Endocyte viel schneller als erhofft.
Dass man das überhaupt ernsthaft diskutiert ist schon ein schönes Zeichen.
PS: Kurs in New York jetzt deutlich zweistellig.
Endocyte Announces Intent to Seek Conditional Marketing Authorization in the European Union for Targeted Therapeutic EC145 and Companion Imaging Diagnostic EC20 for Platinum-Resistant Ovarian Cancer
Filings to be Based on Results of Phase 2 PRECEDENT Trial
WEST LAFAYETTE, Ind., April 26, 2011 – Endocyte, Inc., (NASDAQ: ECYT), a
biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced its plan to prepare two marketing authorization applications to the European Medicines Agency (EMA). These two marketing applications are for the company’s lead drug candidate EC145 for the treatment of platinum-resistant ovarian cancer and its companion imaging diagnostic EC20 for patient selection. The filings will be based on the results of the randomized Phase 2 PRECEDENT trial and supported by a Phase 2 single agent EC145 clinical trial.
“We’ve been in consultation with the EMA regarding our PRECEDENT results and the design of our Phase 3 trial, PROCEED,” said Ron Ellis, president and CEO of Endocyte. “As part of this consultation, we explored the possibility of seeking conditional marketing authorization in the EU based on Phase 2 results. As a result of our interaction with the EMA, including a meeting with the Scientific Advice Working Party and written advice from the Committee for Medicinal Products for Human Use (CHMP), we will prepare marketing applications for both EC145 and EC20. The CHMP welcomed the use of EC20 to select patients with the targeted receptor, so we plan to seek conditional marketing authorization in patients with platinum-resistant ovarian cancer who are EC20 positive. We will discuss these developments during our first quarter conference call scheduled for May 5, 2011.”
The PRECEDENT trial, a randomized, multi-center, international Phase 2 study, investigated EC145 in combination with standard chemotherapy, pegylated liposomal doxorubicin (PLD), for treatment of women with platinum-resistant ovarian cancer and evaluated the utility of EC20 for patient selection. The study met its primary endpoint; the combination of EC145 and PLD showed an improvement in the time to disease progression or death compared to PLD alone. This improvement was more substantial in patients who were selected with the companion imaging diagnostic EC20.
Conditional marketing authorization may be granted in certain situations for medical products which treat life-threatening diseases and provide earlier access to patients in areas of high unmet medical need. Conditional marketing authorizations must be renewed annually and require completion of ongoing or new clinical trials to confirm that the risk-benefit balance is positive.
Endocyte cannot predict with any certainty at this time when it will file the marketing applications nor give any assurance that the applications for conditional marketing authorization for either EC145 or the companion imaging diagnostic EC20 will be approved by the EMA.
----------
Ich bin sehr gespannt, wie das ausgeht! Wenn sich die EMA darauf einlässt, käme der Ritterschlag für Endocyte viel schneller als erhofft.
Dass man das überhaupt ernsthaft diskutiert ist schon ein schönes Zeichen.
PS: Kurs in New York jetzt deutlich zweistellig.
Wie es der Zufall will, äußert sich Ohad Hammer heute im Rahmen eines Artikels über mehrere Unternehmen auch zu Endocyte (Fettungen von mir):
Endocyte
Endocyte (ECYT), who completed its IPO earlier this year is about to start a phase III trial in ovarian cancer. The company is developing small-molecule drug conjugates (SMDC), which comprise of a targeting moiety linked to a toxic cargo. The approach is similar to that of antibody drug conjugates in the specific delivery of drugs to tumors while sparing normal cells. One big difference between SMDCs and ADCs is SMDCs’ small size. On the one hand, this property should make SMDCs more effective at penetrating solid tumors. On the other, they are cleared from the body very quickly which limits their exposure and requires frequent dosing. In addition, SMDCs do not appear potent enough to be used as single agents, which requires phase II proof of concept in large randomized trials.
I was initially skeptical regarding SMDCs but following phase II data presented last year, Endocyte seems to have a very attractive drug, especially in light of a unique patient selection approach. I mentioned the company two months ago as an attractively valued biotech company with a wholly owned asset.
Endocyte’s lead SMDC, EC145, targets folate receptor, a well recognized target that becomes upregulated in certain tumor types. EC145 generated impressive results in a large phase II study in platinum resistant ovarian cancer patients, which is considered a particularly challenging indication, bereft of effective treatments. The trial evaluated the chemotherapy drug Doxil plus EC145 versus Doxil alone. In the entire patient population, the combination almost doubled progression free survival from 11.7 to 21.7 weeks.
This kind of difference is positive by itself but Endocyte was able to generate even more promising data using a novel and unique approach of patient stratification. The company has developed EC20, a companion diagnostic for evaluating the expression of folate receptor on tumors. Unlike most companion diagnostics which rely on a tissue specimen from the patients, Endocyte’s diagnostic marker is injected to patients. This enables an accurate real time assessment of all the tumors a patient has.
Based on the companion diagnostic, Endocyte stratified patients into three groups. 40% of patients expressed folate receptor on all of their tumors (designated EC20++), another 40% expressed the target in some of their tumors (EC20+) and 20% had no expression (EC20-).
Ideally, there should be a profound benefit in EC20++ patients, a milder response in EC20+ and no response in the EC20- patients, which is exactly what the results look like. In the EC20++ group the addition of EC145 to Doxil more than tripled PFS from 6.6 to 24 weeks. The EC20+ patients appeared to benefit but to a lesser extent whereas there was no difference in the EC20- group.
Endocyte plans to use the funds raised in its IPO for starting a phase III study in the coming months. Based on the biomarker data in the phase II, the trial will enroll only EC20+ and EC20++ patients, which increases chances of success. Importantly, the trial is designed in such a way that will allow approval only in EC20++ patients even if the trial fails in the overall population.
In contrast to the phase II, the phase III will be a double blinded study (neither the patient nor the physician know who gets the drug) and PFS will be evaluated by an independent blinded expert. These features were incorporated to neutralize investigator bias, which might had an influence in the phase II.
The market potential for EC145 is substantial, even assuming approval for EC20++ patients only. In the US, ovarian cancer leads to approximately 14 thousand deaths per year. 40% (5,600) of these cases are expected to be EC20++, representing a market opportunity of ~$150-200M, depending on pricing. The ex US market is similar assuming a larger patient population but lower pricing (which will depend on the survival benefit). Obviously, there are multiple opportunities for label expansion in ovarian cancer as well as additional tumor types that express folate receptor.
There are two programs that target folate receptor and thus can be viewed as direct competition to EC145. Morphotek (subsidiary of Eisai) is developing farletuzumab, an antibody targeting folate receptor for ovarian cancer as well. Farletuzumab is currently in a phase III trial in platinum sensitive patients, who have better prognosis than those targeted by Endocyte. In addition, Morphotek does not use a companion diagnostic for patients selection and does not have a robust phase II data set.
Another competitor is Immunogen’s (IMGN) IMGN853, an ADC targeting folate receptor. This agent is expected to enter phase I next year so by the time Immunogen has initial results Endocyte should have phase III data. Nevertheless, as an ADC, IMGN853 could have several advantages over EC145 including potency as a single agent and convenient administration. IMGN853 also employs a new linker that was optimized to circumvent multiple drug resistance.
Results from the trial are expected in mid 2013, but Endocyte will probably sign a partnership deal next year for the EC145’s ex-US rights for the drug. In the first half of next year the company should have overall survival data from the phase II study. A trend in the overall population or a statistically significant result in EC20++ patients will further validate EC145’s potential.
Endocyte
Endocyte (ECYT), who completed its IPO earlier this year is about to start a phase III trial in ovarian cancer. The company is developing small-molecule drug conjugates (SMDC), which comprise of a targeting moiety linked to a toxic cargo. The approach is similar to that of antibody drug conjugates in the specific delivery of drugs to tumors while sparing normal cells. One big difference between SMDCs and ADCs is SMDCs’ small size. On the one hand, this property should make SMDCs more effective at penetrating solid tumors. On the other, they are cleared from the body very quickly which limits their exposure and requires frequent dosing. In addition, SMDCs do not appear potent enough to be used as single agents, which requires phase II proof of concept in large randomized trials.
I was initially skeptical regarding SMDCs but following phase II data presented last year, Endocyte seems to have a very attractive drug, especially in light of a unique patient selection approach. I mentioned the company two months ago as an attractively valued biotech company with a wholly owned asset.
Endocyte’s lead SMDC, EC145, targets folate receptor, a well recognized target that becomes upregulated in certain tumor types. EC145 generated impressive results in a large phase II study in platinum resistant ovarian cancer patients, which is considered a particularly challenging indication, bereft of effective treatments. The trial evaluated the chemotherapy drug Doxil plus EC145 versus Doxil alone. In the entire patient population, the combination almost doubled progression free survival from 11.7 to 21.7 weeks.
This kind of difference is positive by itself but Endocyte was able to generate even more promising data using a novel and unique approach of patient stratification. The company has developed EC20, a companion diagnostic for evaluating the expression of folate receptor on tumors. Unlike most companion diagnostics which rely on a tissue specimen from the patients, Endocyte’s diagnostic marker is injected to patients. This enables an accurate real time assessment of all the tumors a patient has.
Based on the companion diagnostic, Endocyte stratified patients into three groups. 40% of patients expressed folate receptor on all of their tumors (designated EC20++), another 40% expressed the target in some of their tumors (EC20+) and 20% had no expression (EC20-).
Ideally, there should be a profound benefit in EC20++ patients, a milder response in EC20+ and no response in the EC20- patients, which is exactly what the results look like. In the EC20++ group the addition of EC145 to Doxil more than tripled PFS from 6.6 to 24 weeks. The EC20+ patients appeared to benefit but to a lesser extent whereas there was no difference in the EC20- group.
Endocyte plans to use the funds raised in its IPO for starting a phase III study in the coming months. Based on the biomarker data in the phase II, the trial will enroll only EC20+ and EC20++ patients, which increases chances of success. Importantly, the trial is designed in such a way that will allow approval only in EC20++ patients even if the trial fails in the overall population.
In contrast to the phase II, the phase III will be a double blinded study (neither the patient nor the physician know who gets the drug) and PFS will be evaluated by an independent blinded expert. These features were incorporated to neutralize investigator bias, which might had an influence in the phase II.
The market potential for EC145 is substantial, even assuming approval for EC20++ patients only. In the US, ovarian cancer leads to approximately 14 thousand deaths per year. 40% (5,600) of these cases are expected to be EC20++, representing a market opportunity of ~$150-200M, depending on pricing. The ex US market is similar assuming a larger patient population but lower pricing (which will depend on the survival benefit). Obviously, there are multiple opportunities for label expansion in ovarian cancer as well as additional tumor types that express folate receptor.
There are two programs that target folate receptor and thus can be viewed as direct competition to EC145. Morphotek (subsidiary of Eisai) is developing farletuzumab, an antibody targeting folate receptor for ovarian cancer as well. Farletuzumab is currently in a phase III trial in platinum sensitive patients, who have better prognosis than those targeted by Endocyte. In addition, Morphotek does not use a companion diagnostic for patients selection and does not have a robust phase II data set.
Another competitor is Immunogen’s (IMGN) IMGN853, an ADC targeting folate receptor. This agent is expected to enter phase I next year so by the time Immunogen has initial results Endocyte should have phase III data. Nevertheless, as an ADC, IMGN853 could have several advantages over EC145 including potency as a single agent and convenient administration. IMGN853 also employs a new linker that was optimized to circumvent multiple drug resistance.
Results from the trial are expected in mid 2013, but Endocyte will probably sign a partnership deal next year for the EC145’s ex-US rights for the drug. In the first half of next year the company should have overall survival data from the phase II study. A trend in the overall population or a statistically significant result in EC20++ patients will further validate EC145’s potential.
Fierce berichtet wie folgt (mit neuen Aussagen in Sachen FDA):
Endocyte shares spike on plan to seek early approval for lead cancer drug
April 27, 2011 — 9:12am ET | By John Carroll
Shares of Endocyte ($ECYT) shot up 25 percent on Tuesday after the Indiana biotech announced that it plans to push ahead with an application for conditional European approval of its lead drug for advanced ovarian cancer and a companion diagnostic on the basis of Phase II data.
Endocyte's strategy is to use an imaging agent, EC20, to identify patients whose tumors express folate receptors. Those patients who test positive are treated with EC145, which combines a chemotherapy with a conjugate that includes vitamin folate, targeting specific cancer cells. That approach has produced promising results in mid-stage studies. But seeking an approval for a cancer drug with mid-stage data is far from easy, as Roche found out after the FDA handed back its application for T-DM1. But Endocyte says that its talks with European regulators indicated that it may have a solid shot.
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"We've been in consultation with the EMA regarding our PRECEDENT results and the design of our Phase III trial, PROCEED," said Ron Ellis, president and CEO of Endocyte. "As part of this consultation, we explored the possibility of seeking conditional marketing authorization in the EU based on Phase II results. As a result of our interaction with the EMA, including a meeting with the Scientific Advice Working Party and written advice from the Committee for Medicinal Products for Human Use, we will prepare marketing applications for both EC145 and EC20. The CHMP welcomed the use of EC20 to select patients with the targeted receptor, so we plan to seek conditional marketing authorization in patients with platinum-resistant ovarian cancer who are EC20 positive. We will discuss these developments during our first quarter conference call scheduled for May 5, 2011."
Endocyte has also gained some support for its chances at the FDA.
"It is likely, in our view, that FDA could approve EC145 based on a robust, statistically significant progression-free survival advantage, which is later supported by either a strong trend or statistically significant overall survival advantage," noted Jason Kantor, an analyst at RBC Capital Markets.
Endocyte shares spike on plan to seek early approval for lead cancer drug
April 27, 2011 — 9:12am ET | By John Carroll
Shares of Endocyte ($ECYT) shot up 25 percent on Tuesday after the Indiana biotech announced that it plans to push ahead with an application for conditional European approval of its lead drug for advanced ovarian cancer and a companion diagnostic on the basis of Phase II data.
Endocyte's strategy is to use an imaging agent, EC20, to identify patients whose tumors express folate receptors. Those patients who test positive are treated with EC145, which combines a chemotherapy with a conjugate that includes vitamin folate, targeting specific cancer cells. That approach has produced promising results in mid-stage studies. But seeking an approval for a cancer drug with mid-stage data is far from easy, as Roche found out after the FDA handed back its application for T-DM1. But Endocyte says that its talks with European regulators indicated that it may have a solid shot.
Sign up for our FREE newsletter for more news like this sent to your inbox!
"We've been in consultation with the EMA regarding our PRECEDENT results and the design of our Phase III trial, PROCEED," said Ron Ellis, president and CEO of Endocyte. "As part of this consultation, we explored the possibility of seeking conditional marketing authorization in the EU based on Phase II results. As a result of our interaction with the EMA, including a meeting with the Scientific Advice Working Party and written advice from the Committee for Medicinal Products for Human Use, we will prepare marketing applications for both EC145 and EC20. The CHMP welcomed the use of EC20 to select patients with the targeted receptor, so we plan to seek conditional marketing authorization in patients with platinum-resistant ovarian cancer who are EC20 positive. We will discuss these developments during our first quarter conference call scheduled for May 5, 2011."
Endocyte has also gained some support for its chances at the FDA.
"It is likely, in our view, that FDA could approve EC145 based on a robust, statistically significant progression-free survival advantage, which is later supported by either a strong trend or statistically significant overall survival advantage," noted Jason Kantor, an analyst at RBC Capital Markets.
Am 05.05. hat Endocyte über das Q1 berichtet. Interessant war für mich vor allem, dass die P III für EC 145 nun läuft.
Außerdem wurde bestätigt, dass eine vorläufige Zulassung bei der EMA beantragt wird. Für die USA ist dies offensichtlich nicht möglich. Hier muss man auf den PROCEED-Trial warten.
Bei PROCEED wurde das PFS als primärer Endpunkt gewählt. Mitte 2013 sollen die Daten vorliegen.
Initiation of Enrollment for Phase 3 PROCEED trial for EC145: Endocyte announced today that it began enrolling patients for its Phase 3 PROCEED trial for the use of EC145 to treat women with platinum-resistant ovarian cancer. PROCEED is a double-blinded trial designed to measure progression-free survival based on radiological progression and will be powered for an overall survival analysis with planned enrollment of more than 500 patients. Patients in the PROCEED trial will be imaged with the companion imaging diagnostic, EC20, prior to treatment in order to identify patients whose cancer over-expresses the folate receptor, the target of EC145. Patients who are EC20 negative will be excluded from the primary endpoint of the trial. If the trial is successful, the company plans to submit the results of the PROCEED trial, supported by results of its randomized Phase 2 PRECEDENT trial, to the FDA for approval of EC145 and EC20.
Außerdem wurde bestätigt, dass eine vorläufige Zulassung bei der EMA beantragt wird. Für die USA ist dies offensichtlich nicht möglich. Hier muss man auf den PROCEED-Trial warten.
Bei PROCEED wurde das PFS als primärer Endpunkt gewählt. Mitte 2013 sollen die Daten vorliegen.
Initiation of Enrollment for Phase 3 PROCEED trial for EC145: Endocyte announced today that it began enrolling patients for its Phase 3 PROCEED trial for the use of EC145 to treat women with platinum-resistant ovarian cancer. PROCEED is a double-blinded trial designed to measure progression-free survival based on radiological progression and will be powered for an overall survival analysis with planned enrollment of more than 500 patients. Patients in the PROCEED trial will be imaged with the companion imaging diagnostic, EC20, prior to treatment in order to identify patients whose cancer over-expresses the folate receptor, the target of EC145. Patients who are EC20 negative will be excluded from the primary endpoint of the trial. If the trial is successful, the company plans to submit the results of the PROCEED trial, supported by results of its randomized Phase 2 PRECEDENT trial, to the FDA for approval of EC145 and EC20.
Die Website wurde neu gestaltet (das wurde auch Zeit). Die Grafikeinbidung in Beitrag 1 scheint nun aber nicht mehr zu funktionieren, weshalb ich sie hier wiederhole.
Prinzip eines SMDC
Pipeline
Prinzip eines SMDC
Pipeline
Die heutige Meldung bringt nichts substanziell neues, fasst den Stand der Dinge aber gut zusammen:
Endocyte's EC145 Meets Primary Endpoint in Phase 2 Study, Demonstrating 85 Percent (2.3 month) Improvement in Median Progression-Free Survival for Treatment of Platinum Resistant Ovarian Cancer
- Data Presented at 2011 ASCO Annual Meeting
- 260 Percent (4.0 Month) Increase in Median Progression-Free Survival in Folate Receptor Positive Patient Subgroup
- Plan to File for Conditional Approval in Europe
- Initiated Phase 3 PROCEED Trial
WEST LAFAYETTE, Ind., June 5, 2011 (GLOBE NEWSWIRE) -- Endocyte, Inc., (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced that the Phase 2 PRECEDENT trial, investigating the company's lead drug candidate, EC145, in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant ovarian cancer, met its primary endpoint by showing an 85 percent, 2.3 month, improvement in median progression-free survival (PFS) in the intent-to-treat population and a 260 percent, 4.0 month, improvement in a subset of folate receptor positive patients. EC145 in combination with PLD showed limited additional toxicity compared to standard therapy with PLD alone. The most commonly occurring adverse events were neutropenia, small intestine obstruction, and palmar-plantar erythrodysesthesia. EC145 is a therapeutic that targets the folate receptor and EC20 is a companion imaging diagnostic used to assess folate receptor presence.
These final PFS data from the PRECEDENT trial were presented today at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO), in Chicago, Illinois and are available at http://investor.endocyte.com/events.cfm.
"I am encouraged by these data as EC145 is the first drug candidate to demonstrate a significant improvement in PFS in a randomized trial of patients with platinum-resistant ovarian cancer, a very challenging disease with a high unmet need. Historical data show that for these patients on standard therapy, PFS is approximately three months and overall survival is approximately twelve months. No new drug has been approved in the U.S. for this indication in over a decade," said Wendel Naumann, M.D., Associate Director of Gynecologic Oncology at Blumenthal Cancer Center, Carolinas Medical Center. "In addition the companion imaging diagnostic, EC20, is designed to identify patients who over-express the targeted receptor and are most likely to respond to EC145. This represents a personalized therapeutic approach that I believe will help oncologists direct patients to the most promising treatment."
The Phase 2 PRECEDENT trial was an international, multi-center, randomized study of 149 women with platinum-resistant ovarian cancer. Patients were randomized to receive EC145 plus PLD or PLD alone at a standard dose until disease progression or death. The primary endpoint of the study was progression-free survival. Secondary endpoints included response rate and overall survival.
In particular the PRECEDENT trial data showed:
85 Percent (2.3 Month) Improvement in Median PFS for All Patients
Patients receiving EC145 in combination with PLD, regardless of folate receptor expression, had a median progression free survival of 5.0 months compared to 2.7 months for patients receiving single agent PLD. The hazard ratio for PFS was 0.626 (p=0.031). The overall response rate was 28 percent in the EC145 combination group versus 16 percent in the PLD-alone group. CA-125 responses were also more common in patients receiving EC145 in combination with PLD compared to those receiving PLD alone, with response rates of 38 percent and 19 percent, respectively.
260 Percent (4.0 Month) Improvement in Median PFS for Patients Most Positive for Folate Receptor
The study also utilized EC20, an investigational companion imaging diagnostic that is designed to identify patients with folate receptor positive tumors. As expected, in the folate receptor positive patients the improvement in PFS was even greater. In the subpopulation most positive for the folate receptor, PFS increased 4.0 months from 1.5 months to 5.5 months. The hazard ratio for PFS was 0.381 (p=0.018). This represents more than a 60 percent reduction in the risk of progression and provides evidence supporting the mechanism of action through targeting of the folate receptor. The overall response rate was 22 percent in the EC145 combination group versus 7 percent in the PLD-alone group. CA-125 responses were also more common in patients receiving EC145 in combination with PLD compared to those receiving PLD alone, 43 percent and 13 percent, respectively.
"We see tremendous potential for continued development of EC145 based on these data that demonstrate, for the first time, a significant improvement in PFS in patients with platinum resistant ovarian cancer," said Ron Ellis, President and Chief Executive Officer of Endocyte. "We have already advanced EC145 into Phase 3 evaluation with the PROCEED trial, which has a similar design to the PRECEDENT trial, and plan to file for regulatory approval in the European Union based on the PFS data from the PRECEDENT study."
Plan to File PRECEDENT Data for Conditional Approval in Europe
As a result of Endocyte's interaction with the European Medicines Agency (EMA), including a meeting with the Scientific Advice Working Party and written advice from the Committee for Medicinal Products for Human Use (CHMP), the Company will prepare marketing applications for both EC145 and EC20. Based on feedback from the CHMP, Endocyte plans to seek conditional marketing authorization for patients with platinum-resistant ovarian cancer who test positive for the folate receptor using the EC20 companion imaging diagnostic.
Phase 3 PROCEED Trial Initiated
Endocyte recently announced the initiation of patient enrollment in the Phase 3 PROCEED trial of EC145 structured to replicate the PRECEDENT trial design. The Phase 3 trial is a randomized, double-blinded trial of EC145 in combination with PLD compared to PLD plus placebo. The patient population, those with platinum-resistant ovarian cancer, will be the same as in the PRECEDENT trial, and the primary endpoint will be progression-free survival in patients selected by EC20 as folate-receptor positive. The trial will also be statistically powered for overall survival as a secondary endpoint with projected enrollment in excess of 500 patients. The trial will be conducted in approximately 150 sites in the U.S., Canada, and Europe. More information regarding the trial is available at www.clinicaltrials.gov.
Endocyte's EC145 Meets Primary Endpoint in Phase 2 Study, Demonstrating 85 Percent (2.3 month) Improvement in Median Progression-Free Survival for Treatment of Platinum Resistant Ovarian Cancer
- Data Presented at 2011 ASCO Annual Meeting
- 260 Percent (4.0 Month) Increase in Median Progression-Free Survival in Folate Receptor Positive Patient Subgroup
- Plan to File for Conditional Approval in Europe
- Initiated Phase 3 PROCEED Trial
WEST LAFAYETTE, Ind., June 5, 2011 (GLOBE NEWSWIRE) -- Endocyte, Inc., (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced that the Phase 2 PRECEDENT trial, investigating the company's lead drug candidate, EC145, in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant ovarian cancer, met its primary endpoint by showing an 85 percent, 2.3 month, improvement in median progression-free survival (PFS) in the intent-to-treat population and a 260 percent, 4.0 month, improvement in a subset of folate receptor positive patients. EC145 in combination with PLD showed limited additional toxicity compared to standard therapy with PLD alone. The most commonly occurring adverse events were neutropenia, small intestine obstruction, and palmar-plantar erythrodysesthesia. EC145 is a therapeutic that targets the folate receptor and EC20 is a companion imaging diagnostic used to assess folate receptor presence.
These final PFS data from the PRECEDENT trial were presented today at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO), in Chicago, Illinois and are available at http://investor.endocyte.com/events.cfm.
"I am encouraged by these data as EC145 is the first drug candidate to demonstrate a significant improvement in PFS in a randomized trial of patients with platinum-resistant ovarian cancer, a very challenging disease with a high unmet need. Historical data show that for these patients on standard therapy, PFS is approximately three months and overall survival is approximately twelve months. No new drug has been approved in the U.S. for this indication in over a decade," said Wendel Naumann, M.D., Associate Director of Gynecologic Oncology at Blumenthal Cancer Center, Carolinas Medical Center. "In addition the companion imaging diagnostic, EC20, is designed to identify patients who over-express the targeted receptor and are most likely to respond to EC145. This represents a personalized therapeutic approach that I believe will help oncologists direct patients to the most promising treatment."
The Phase 2 PRECEDENT trial was an international, multi-center, randomized study of 149 women with platinum-resistant ovarian cancer. Patients were randomized to receive EC145 plus PLD or PLD alone at a standard dose until disease progression or death. The primary endpoint of the study was progression-free survival. Secondary endpoints included response rate and overall survival.
In particular the PRECEDENT trial data showed:
85 Percent (2.3 Month) Improvement in Median PFS for All Patients
Patients receiving EC145 in combination with PLD, regardless of folate receptor expression, had a median progression free survival of 5.0 months compared to 2.7 months for patients receiving single agent PLD. The hazard ratio for PFS was 0.626 (p=0.031). The overall response rate was 28 percent in the EC145 combination group versus 16 percent in the PLD-alone group. CA-125 responses were also more common in patients receiving EC145 in combination with PLD compared to those receiving PLD alone, with response rates of 38 percent and 19 percent, respectively.
260 Percent (4.0 Month) Improvement in Median PFS for Patients Most Positive for Folate Receptor
The study also utilized EC20, an investigational companion imaging diagnostic that is designed to identify patients with folate receptor positive tumors. As expected, in the folate receptor positive patients the improvement in PFS was even greater. In the subpopulation most positive for the folate receptor, PFS increased 4.0 months from 1.5 months to 5.5 months. The hazard ratio for PFS was 0.381 (p=0.018). This represents more than a 60 percent reduction in the risk of progression and provides evidence supporting the mechanism of action through targeting of the folate receptor. The overall response rate was 22 percent in the EC145 combination group versus 7 percent in the PLD-alone group. CA-125 responses were also more common in patients receiving EC145 in combination with PLD compared to those receiving PLD alone, 43 percent and 13 percent, respectively.
"We see tremendous potential for continued development of EC145 based on these data that demonstrate, for the first time, a significant improvement in PFS in patients with platinum resistant ovarian cancer," said Ron Ellis, President and Chief Executive Officer of Endocyte. "We have already advanced EC145 into Phase 3 evaluation with the PROCEED trial, which has a similar design to the PRECEDENT trial, and plan to file for regulatory approval in the European Union based on the PFS data from the PRECEDENT study."
Plan to File PRECEDENT Data for Conditional Approval in Europe
As a result of Endocyte's interaction with the European Medicines Agency (EMA), including a meeting with the Scientific Advice Working Party and written advice from the Committee for Medicinal Products for Human Use (CHMP), the Company will prepare marketing applications for both EC145 and EC20. Based on feedback from the CHMP, Endocyte plans to seek conditional marketing authorization for patients with platinum-resistant ovarian cancer who test positive for the folate receptor using the EC20 companion imaging diagnostic.
Phase 3 PROCEED Trial Initiated
Endocyte recently announced the initiation of patient enrollment in the Phase 3 PROCEED trial of EC145 structured to replicate the PRECEDENT trial design. The Phase 3 trial is a randomized, double-blinded trial of EC145 in combination with PLD compared to PLD plus placebo. The patient population, those with platinum-resistant ovarian cancer, will be the same as in the PRECEDENT trial, and the primary endpoint will be progression-free survival in patients selected by EC20 as folate-receptor positive. The trial will also be statistically powered for overall survival as a secondary endpoint with projected enrollment in excess of 500 patients. The trial will be conducted in approximately 150 sites in the U.S., Canada, and Europe. More information regarding the trial is available at www.clinicaltrials.gov.
Der Kurs hat sich weiter stark gezeigt und das wird jetzt ausgenutzt:
WEST LAFAYETTE, Ind., Jul 14, 2011 (GlobeNewswire via COMTEX) -- Endocyte, Inc. /quotes/zigman/119422/quotes/nls/ecyt ECYT -0.79% , a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, announced today that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed underwritten public offering of 4,841,610 shares of its common stock. The Company is offering 4,000,000 shares and an existing institutional shareholder will sell the remaining shares. In addition, Endocyte has granted the underwriters the option to purchase up to 726,241 additional shares to cover over-allotments.
RBC Capital Markets, LLC and Leerink Swann LLC are acting as joint book-running managers, with Cowen and Company, LLC and Wedbush PacGrow Life Sciences acting as co-managers for the offering.
WEST LAFAYETTE, Ind., Jul 14, 2011 (GlobeNewswire via COMTEX) -- Endocyte, Inc. /quotes/zigman/119422/quotes/nls/ecyt ECYT -0.79% , a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, announced today that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed underwritten public offering of 4,841,610 shares of its common stock. The Company is offering 4,000,000 shares and an existing institutional shareholder will sell the remaining shares. In addition, Endocyte has granted the underwriters the option to purchase up to 726,241 additional shares to cover over-allotments.
RBC Capital Markets, LLC and Leerink Swann LLC are acting as joint book-running managers, with Cowen and Company, LLC and Wedbush PacGrow Life Sciences acting as co-managers for the offering.
Hier mal die für mich interessantesten Passagen aus dem letzten Q-Bericht:
"We are currently preparing marketing authorization applications for the use of EC145 and EC20 in the treatment of patients with folate-receptor positive platinum-resistant ovarian cancer in the European Union (EU) and expect to file those applications in the first quarter of 2012,"
Additionally, we are moving forward with a Phase 2 trial of EC145 in non-small cell lung cancer in the first quarter of 2012.
Completed public equity offering with net proceeds of $66.8 million: On August 2, 2011, Endocyte closed an underwritten public offering in which it sold 5,839,810 shares of its common stock at $12.26 per share.
(Das kam ja gerade noch rechtzeitig vor dem Biotech-Blutbad der letzten Tage...)
Endocyte plans to initiate a randomized Phase 2 trial in the first
quarter of 2012. The trial is currently designed to enroll up to 200
patients with adenocarcinoma of the lung who have failed one prior line
of therapy. Patients will be selected based on EC20 scan results and
only folate receptor positive patients will be included. The trial
design is intended to evaluate the safety and efficacy of EC145 as
second line treatment in NSCLC as a single agent and in combination with
docetaxel, an FDA approved and commonly used second line chemotherapy.
The study will have three arms: docetaxel alone; EC145 alone; and EC145
plus docetaxel. The EC145 dosing schedule will be consistent with the
PRECEDENT trial. The primary outcome measure will be progression-free
survival with secondary measures of overall survival, tumor response and
duration of response. Final progression-free survival data are expected
to be available by the third quarter of 2013.
--------------
Tja, könnten wir schon nächstes Jahr "commercial stage" sein...
"We are currently preparing marketing authorization applications for the use of EC145 and EC20 in the treatment of patients with folate-receptor positive platinum-resistant ovarian cancer in the European Union (EU) and expect to file those applications in the first quarter of 2012,"
Additionally, we are moving forward with a Phase 2 trial of EC145 in non-small cell lung cancer in the first quarter of 2012.
Completed public equity offering with net proceeds of $66.8 million: On August 2, 2011, Endocyte closed an underwritten public offering in which it sold 5,839,810 shares of its common stock at $12.26 per share.
(Das kam ja gerade noch rechtzeitig vor dem Biotech-Blutbad der letzten Tage...)
Endocyte plans to initiate a randomized Phase 2 trial in the first
quarter of 2012. The trial is currently designed to enroll up to 200
patients with adenocarcinoma of the lung who have failed one prior line
of therapy. Patients will be selected based on EC20 scan results and
only folate receptor positive patients will be included. The trial
design is intended to evaluate the safety and efficacy of EC145 as
second line treatment in NSCLC as a single agent and in combination with
docetaxel, an FDA approved and commonly used second line chemotherapy.
The study will have three arms: docetaxel alone; EC145 alone; and EC145
plus docetaxel. The EC145 dosing schedule will be consistent with the
PRECEDENT trial. The primary outcome measure will be progression-free
survival with secondary measures of overall survival, tumor response and
duration of response. Final progression-free survival data are expected
to be available by the third quarter of 2013.
--------------
Tja, könnten wir schon nächstes Jahr "commercial stage" sein...
Stocks in Play: Insiders are buying shares of Endocyte Incorporated (ECYT)
Endocyte Inc. (ECYT): ECYT develops targeted therapies using small molecule drug conjugates for the treatment of cancer and inflammatory diseases. On Tuesday, Boston-based biotech focused hedge fund RA Capital Management filed SEC form SC 13G indicating that it now holds 2.6 million or 7.3% of outstanding shares, an increase of 2.2 million shares from the 0.4 million shares that it held at the time of its 13-F Q3 filing.
Endocyte, Inc. (NasdaqGM: ECYT )
We wrote recently about RA Capital’s top biotech new buys and sells in Q3, noting that ECYT was a new purchase in Q3. This is the second biotech-focused institutional investor that has purchased ECYT recently as we noted just last Thursday that CA-based venture capital firm Sanderling Venture Partners that specializes in investing in biotech companies filed SEC Forms 4 indicating that they purchased an additional 440,000 shares for $1.4 million, increasing their ownership to 4.5 million shares. Furthermore, insiders have also been on a buying spree at ECYT recently, as five insiders together reported purchasing 226,000 shares in December. ECYT shares are among December’s strongest movers to the downside (down by two-thirds so far), after the company announced on December 13th the results of supplemental analyses of its phase 2b PRECEDENT trial. The heavy insider and sector-focused institutional buying is particularly notable in this context as it signifies that knowledgeable insiders and institutions through their buying of company shares seem to think that the selling is overdone here, portending that we may be near a bottom.
We are very bullish on shares of (ECYT) and we are placing a short term price target of $6.50 cents a share. The chart is getting stronger insiders and hedge funds are snapping up shares 400,000 shares at a time! Major updates will be announced over the next few weeks sending this stock much higher then the current price per share. The stock closed very close to the daily high of $3.76 cents a share rising about 8% during Friday’s market session. Look for the stock to break $4.00 and then let the fun begin! Happy New Year’s to each and every one of you! We hope that 2012 is your biggest and best year yet!
http://hotpennystocksonline.com/?p=766
Endocyte Inc. (ECYT): ECYT develops targeted therapies using small molecule drug conjugates for the treatment of cancer and inflammatory diseases. On Tuesday, Boston-based biotech focused hedge fund RA Capital Management filed SEC form SC 13G indicating that it now holds 2.6 million or 7.3% of outstanding shares, an increase of 2.2 million shares from the 0.4 million shares that it held at the time of its 13-F Q3 filing.
Endocyte, Inc. (NasdaqGM: ECYT )
We wrote recently about RA Capital’s top biotech new buys and sells in Q3, noting that ECYT was a new purchase in Q3. This is the second biotech-focused institutional investor that has purchased ECYT recently as we noted just last Thursday that CA-based venture capital firm Sanderling Venture Partners that specializes in investing in biotech companies filed SEC Forms 4 indicating that they purchased an additional 440,000 shares for $1.4 million, increasing their ownership to 4.5 million shares. Furthermore, insiders have also been on a buying spree at ECYT recently, as five insiders together reported purchasing 226,000 shares in December. ECYT shares are among December’s strongest movers to the downside (down by two-thirds so far), after the company announced on December 13th the results of supplemental analyses of its phase 2b PRECEDENT trial. The heavy insider and sector-focused institutional buying is particularly notable in this context as it signifies that knowledgeable insiders and institutions through their buying of company shares seem to think that the selling is overdone here, portending that we may be near a bottom.
We are very bullish on shares of (ECYT) and we are placing a short term price target of $6.50 cents a share. The chart is getting stronger insiders and hedge funds are snapping up shares 400,000 shares at a time! Major updates will be announced over the next few weeks sending this stock much higher then the current price per share. The stock closed very close to the daily high of $3.76 cents a share rising about 8% during Friday’s market session. Look for the stock to break $4.00 and then let the fun begin! Happy New Year’s to each and every one of you! We hope that 2012 is your biggest and best year yet!
http://hotpennystocksonline.com/?p=766
ist hier ejmand investiert? wie sind die aussichten eurer meinung nach ?
Mit so etwas hätte ich wirklich nicht mehr gerechnet!
Merck and Endocyte Enter Exclusive Worldwide Agreement to Develop and Commercialize Phase III Cancer Candidate Vintafolide (EC145)
April 16, 2012 | By Jennifer Levin
Merck and Endocyte Enter Exclusive Worldwide Agreement to Develop and Commercialize Phase III Cancer Candidate Vintafolide (EC145)
WHITEHOUSE STATION N.J. & WEST LAFAYETTE, Ind., Apr 16, 2012 (BUSINESS WIRE) -- Merck, known as MSD outside the United States and Canada, and Endocyte Inc., today announced that they have entered into an agreement to develop and commercialize Endocyte's novel investigational therapeutic candidate vintafolide (EC145). Vintafolide is currently being evaluated in a Phase III clinical trial for platinum-resistant ovarian cancer, (PROCEED trial) and a Phase II trial for non-small cell lung cancer (NSCLC); both studies are also using Endocyte's investigational companion diagnostic agent, etarfolatide (EC20).
"Vintafolide is a promising and innovative late-stage cancer drug candidate. In addition to pursuing the lead indication of platinum-resistant ovarian cancer, Merck plans to further evaluate its potential for treatment of multiple other cancer types," said Peter S. Kim, executive vice president and president Merck Research Laboratories. "This agreement underscores our strategy of building a portfolio of oncology therapeutics that employ a companion diagnostic to facilitate selection of those patients most likely to respond to treatment."
Under the agreement, Merck, through a subsidiary, will gain worldwide rights to develop and commercialize vintafolide. Endocyte will receive a $120 million upfront payment and is eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory and commercialization goals for vintafolide for a total of six cancer indications. In addition, if vintafolide receives regulatory approval, Endocyte will receive an equal share of the profit in the United States (U.S.) as well as a double digit percentage royalty on sales of the product in the rest of the world. Endocyte has retained the right to co-promote vintafolide with Merck in the U.S. and Merck has the exclusive right to promote vintafolide in the rest of world. Endocyte will be responsible for the majority of funding and completion of the PROCEED trial. Merck will be responsible for all other development activities and costs and have all decision rights for vintafolide. Endocyte remains responsible for the development, manufacture and commercialization worldwide of etarfolatide, a non-invasive companion diagnostic imaging agent that is used to identify folate receptor positive tumor cells.
"Following a rigorous selection process we believe Merck represents the ideal strategic partner to achieve the full potential of vintafolide, accelerating our development in numerous cancers," said Ron Ellis, Endocyte's president and chief executive officer. "The agreement also positions us well to build our own commercial infrastructure for vintafolide in the U.S. and for etarfolatide worldwide."
Endocyte has completed three single arm studies of vintafolide in patients with advanced platinum resistant ovarian cancer, non-small cell lung cancer and solid tumors. In a randomized Phase II clinical trial (PRECEDENT) comparing vintafolide plus pegylated liposomal doxorubicin (PLD) versus PLD alone in women with platinum-resistant ovarian cancer, vintafolide demonstrated a statistically significant delay in disease progression or death in the overall population, with the largest improvement observed in patients with all tumors imaged as positive for folate receptor expression utilizing etarfolatide. Vintafolide in combination showed limited additional toxicity versus standard therapy with PLD alone. Common adverse events observed with this combination were neutropenia, fatigue, mouth sores, and redness/swelling/pain on the hands and feet.
In March 2012, Endocyte announced that the European Union had granted orphan drug status to vintafolide, and that the company planned to file a marketing authorization application in the third quarter of 2012.
Closing of the transaction is contingent upon obtaining Hart-Scott Rodino clearance from the Federal Trade Commission.
Merck and Endocyte Enter Exclusive Worldwide Agreement to Develop and Commercialize Phase III Cancer Candidate Vintafolide (EC145)
April 16, 2012 | By Jennifer Levin
Merck and Endocyte Enter Exclusive Worldwide Agreement to Develop and Commercialize Phase III Cancer Candidate Vintafolide (EC145)
WHITEHOUSE STATION N.J. & WEST LAFAYETTE, Ind., Apr 16, 2012 (BUSINESS WIRE) -- Merck, known as MSD outside the United States and Canada, and Endocyte Inc., today announced that they have entered into an agreement to develop and commercialize Endocyte's novel investigational therapeutic candidate vintafolide (EC145). Vintafolide is currently being evaluated in a Phase III clinical trial for platinum-resistant ovarian cancer, (PROCEED trial) and a Phase II trial for non-small cell lung cancer (NSCLC); both studies are also using Endocyte's investigational companion diagnostic agent, etarfolatide (EC20).
"Vintafolide is a promising and innovative late-stage cancer drug candidate. In addition to pursuing the lead indication of platinum-resistant ovarian cancer, Merck plans to further evaluate its potential for treatment of multiple other cancer types," said Peter S. Kim, executive vice president and president Merck Research Laboratories. "This agreement underscores our strategy of building a portfolio of oncology therapeutics that employ a companion diagnostic to facilitate selection of those patients most likely to respond to treatment."
Under the agreement, Merck, through a subsidiary, will gain worldwide rights to develop and commercialize vintafolide. Endocyte will receive a $120 million upfront payment and is eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory and commercialization goals for vintafolide for a total of six cancer indications. In addition, if vintafolide receives regulatory approval, Endocyte will receive an equal share of the profit in the United States (U.S.) as well as a double digit percentage royalty on sales of the product in the rest of the world. Endocyte has retained the right to co-promote vintafolide with Merck in the U.S. and Merck has the exclusive right to promote vintafolide in the rest of world. Endocyte will be responsible for the majority of funding and completion of the PROCEED trial. Merck will be responsible for all other development activities and costs and have all decision rights for vintafolide. Endocyte remains responsible for the development, manufacture and commercialization worldwide of etarfolatide, a non-invasive companion diagnostic imaging agent that is used to identify folate receptor positive tumor cells.
"Following a rigorous selection process we believe Merck represents the ideal strategic partner to achieve the full potential of vintafolide, accelerating our development in numerous cancers," said Ron Ellis, Endocyte's president and chief executive officer. "The agreement also positions us well to build our own commercial infrastructure for vintafolide in the U.S. and for etarfolatide worldwide."
Endocyte has completed three single arm studies of vintafolide in patients with advanced platinum resistant ovarian cancer, non-small cell lung cancer and solid tumors. In a randomized Phase II clinical trial (PRECEDENT) comparing vintafolide plus pegylated liposomal doxorubicin (PLD) versus PLD alone in women with platinum-resistant ovarian cancer, vintafolide demonstrated a statistically significant delay in disease progression or death in the overall population, with the largest improvement observed in patients with all tumors imaged as positive for folate receptor expression utilizing etarfolatide. Vintafolide in combination showed limited additional toxicity versus standard therapy with PLD alone. Common adverse events observed with this combination were neutropenia, fatigue, mouth sores, and redness/swelling/pain on the hands and feet.
In March 2012, Endocyte announced that the European Union had granted orphan drug status to vintafolide, and that the company planned to file a marketing authorization application in the third quarter of 2012.
Closing of the transaction is contingent upon obtaining Hart-Scott Rodino clearance from the Federal Trade Commission.
Ob gerechnet damit oder nicht, warst Du investiert.?!
Antwort auf Beitrag Nr.: 43.047.160 von kyron7htx am 17.04.12 07:38:15Nein, nicht mehr. 
So ist Biotech. Nach den schwachen OS-Daten damals mochte ich nicht mehr.
Bleibe auch jetzt noch etwas skeptisch und beobachte nur.
So ist Biotech. Nach den schwachen OS-Daten damals mochte ich nicht mehr.Bleibe auch jetzt noch etwas skeptisch und beobachte nur.
Antwort auf Beitrag Nr.: 43.047.616 von SLGramann am 17.04.12 09:28:55Dann beobachte mal BPAX-Biosante Pharmaceuticals. Einstiegspreise. Haben stark verloren. Natürlich Biotech immer Risiko. Aber ich glaube hier könnte mit einer Nachricht ein Verdoppler oder mehr drin sein.
Year End 2012
Financial Results
http://www.endocyte.com/wp-content/uploads/2011/04/2013.02.2…
Cash, cash equivalents and investments were
$ 201.4 million at Dec. 31, 2012
Financial Results
http://www.endocyte.com/wp-content/uploads/2011/04/2013.02.2…
Cash, cash equivalents and investments were
$ 201.4 million at Dec. 31, 2012
die hab ich nun schon sooo lange auf der Watchlist ...
heute habe ich mal ein paar gekauft.
Vielen Dank an GLramann, der so lange ausführlich und allein hier Informationen zur Verfügung gestellt hat. Die sind alle samt veraltet, aber jetzt sollten Daten der Phase III kommen ....
heute habe ich mal ein paar gekauft.
Vielen Dank an GLramann, der so lange ausführlich und allein hier Informationen zur Verfügung gestellt hat. Die sind alle samt veraltet, aber jetzt sollten Daten der Phase III kommen ....
nach meinem Einstieg ging es ins Tal des Jammerns. Ich wollte aufgeben und habe schon zwei mal mit Limit verkaufen wollen. Immer nur Tagesgültig und in fallende Kurse hinein, so dass ich auf den Aktien sitzen blieb.
Jetzt ziehen sie wieder an. Jetzt verkaufe ich sie erst mal nicht mehr. Es war ja nur schlechtes timing, fundamental stehen News an und letztlich hatte ich auf DIE gewettet.
Am 1. Oktober kam dann eine Meldung zur Analyse der Resultate. Kurz gefasst eher positiv bis gut
http://www.endocyte.com/wp-content/uploads/2011/04/2013.10.0…
Jetzt ziehen sie wieder an. Jetzt verkaufe ich sie erst mal nicht mehr. Es war ja nur schlechtes timing, fundamental stehen News an und letztlich hatte ich auf DIE gewettet.
Am 1. Oktober kam dann eine Meldung zur Analyse der Resultate. Kurz gefasst eher positiv bis gut
http://www.endocyte.com/wp-content/uploads/2011/04/2013.10.0…
http://seekingalpha.com/article/1719352-2-are-better-than-1-…
In diesem Artikel wird beschrieben, dass Endocyte einen interessanten Ansatz hat, weil die therapeutischen Moleküle an Zielträger gebunden werden. Damit kann das Medikament genauer dorthin gelangen, wo es erwünscht ist.
Hier noch mal der link vom vorherigen posting
http://www.endocyte.com/wp-content/uploads/2011/04/2013.10.0…
Nach der doch einschneidenen Kursbewegung der letzen Wochen, sollte einem weiteren Anstieg nichts mehr im Wege sein.
In diesem Artikel wird beschrieben, dass Endocyte einen interessanten Ansatz hat, weil die therapeutischen Moleküle an Zielträger gebunden werden. Damit kann das Medikament genauer dorthin gelangen, wo es erwünscht ist.
Hier noch mal der link vom vorherigen posting
http://www.endocyte.com/wp-content/uploads/2011/04/2013.10.0…
Nach der doch einschneidenen Kursbewegung der letzen Wochen, sollte einem weiteren Anstieg nichts mehr im Wege sein.
http://www.endocyte.com/wp-content/uploads/2011/04/2013.10.1…
In der eldung heißt es, dass "t vintafolide monotherapy is not likely to be
declared superior to docetaxel in
progression - free survival"
Darauf wurde in Berlin bereits abverkauft und ein Kurseinbruch von 13 % verursacht.
Wenn man weiter ließt, wird klar, dass Vintafolide nicht als Monotherapie eingesetzt wird, sondern als Vergleich für zwei weitere Derivate, die bereits in Phase 3 erprobt werden.
Und wenn ich aus früheren Beschreibungen richtig erinnere, wären diese Moleküle gewissermaßen Lotsen, die ein eigentliches Medikament zur Zielzelle transportieren sollen.
Ich bin nicht sicher, wie das nun zu werten ist. In der Meldung ist man zufrieden
"We are very pleased that our combination therapy of vintafolide and docetaxel successfully passed the predefined interim analysis,..."
Meine Befürchtung ist Verunsicherung und Abverkauf wie in Berlin. Wer seine Dinger also noch schnell rausschmeißen will, muss mindestens die 13 % Minus einkalkulieren.
Da im Vorfeld schon der Kurs nicht richtig lief, immer stark abverkauft wurde, gehe ich von Insidern aus und dass der Abverkauf heute 30% Verlust einbringen könnte.
Aber wer weiß das schon.....
In der eldung heißt es, dass "t vintafolide monotherapy is not likely to be
declared superior to docetaxel in
progression - free survival"
Darauf wurde in Berlin bereits abverkauft und ein Kurseinbruch von 13 % verursacht.
Wenn man weiter ließt, wird klar, dass Vintafolide nicht als Monotherapie eingesetzt wird, sondern als Vergleich für zwei weitere Derivate, die bereits in Phase 3 erprobt werden.
Und wenn ich aus früheren Beschreibungen richtig erinnere, wären diese Moleküle gewissermaßen Lotsen, die ein eigentliches Medikament zur Zielzelle transportieren sollen.
Ich bin nicht sicher, wie das nun zu werten ist. In der Meldung ist man zufrieden
"We are very pleased that our combination therapy of vintafolide and docetaxel successfully passed the predefined interim analysis,..."
Meine Befürchtung ist Verunsicherung und Abverkauf wie in Berlin. Wer seine Dinger also noch schnell rausschmeißen will, muss mindestens die 13 % Minus einkalkulieren.
Da im Vorfeld schon der Kurs nicht richtig lief, immer stark abverkauft wurde, gehe ich von Insidern aus und dass der Abverkauf heute 30% Verlust einbringen könnte.
Aber wer weiß das schon.....
-23% sind es geworden und Schlusskurs nahe dem Tiefstkurs. Das läßt nichts gutes erwarten für die nächsten Tage.
Es bleibt mir weiter nicht klar, warum die sich in der Meldung zufrieden geben, aber die Wahrnehmung an der Börse so negativ ausfällt.
Besteht da ein Mißverständnis bei mir oder im Markt? Der Markt hat immer recht, ich weiß schon ... aber?
Es bleibt mir weiter nicht klar, warum die sich in der Meldung zufrieden geben, aber die Wahrnehmung an der Börse so negativ ausfällt.
Besteht da ein Mißverständnis bei mir oder im Markt? Der Markt hat immer recht, ich weiß schon ... aber?
der heutige Kursanstieg ist dann wohl so zu deuten, dass sich der arkt geirrt hatte, oder?
heute geht es bei sehr vielen Biotechs abwärts, so auch hier, nein hier etwas stärker, im Mo 8 %
SLGramann hat lange durchgehalten,
dann kam dottore und hat ein paar Monate gepostet...
ich befürchte er hat an dem tag mit 8% Minus dann auch verkauft. oder zumindest nahe der Tiefstkurse, einstellig. Jetzt sind wir bei 24$
und nun kommt kara-ben-nemsi, der mit Endocyte Aktien sein Glück versucht! Einstiegskurs ca 23$
Horrido!
dann kam dottore und hat ein paar Monate gepostet...
ich befürchte er hat an dem tag mit 8% Minus dann auch verkauft. oder zumindest nahe der Tiefstkurse, einstellig. Jetzt sind wir bei 24$
und nun kommt kara-ben-nemsi, der mit Endocyte Aktien sein Glück versucht! Einstiegskurs ca 23$
Horrido!
Antwort auf Beitrag Nr.: 46.756.399 von Kara-ben-nemsi am 02.04.14 22:40:07…..und nun kommt kara-ben-nemsi, der mit Endocyte Aktien sein Glück versucht! Einstiegskurs ca 23$...
heute unter 7 $
heute unter 7 $
bin seit heute auch dabei,mal sehen was geht..
Ich bin hier auch dabei aber leider viel höher eingestiegen. Hat jemand Infos warum der Kurs aktuell anzieht, oder einfach nur Short Eindeckungen?!
Antwort auf Beitrag Nr.: 47.747.313 von RealismusinderSpekulation am 10.09.14 19:56:18ist natürlich ein wichtiger grund,mehrere analysten haben endocyt hochgestuft(kursziele 20-22usd)positive komentare wie z.b.seeking alpha..aktie erwacht aus dem dornröschenschlaf
umsetze nehmen deutlich zu,es kommen noch daten zu lungenkrebsstudie ende september
da wirds nochmal richtig spannend..
für mich momentan die topaktie zur kursvervielfachung..
umsetze nehmen deutlich zu,es kommen noch daten zu lungenkrebsstudie ende september
da wirds nochmal richtig spannend..
für mich momentan die topaktie zur kursvervielfachung..
Danke für die Info! Dann warten wir mal ab was die Daten so bringen und hoffen auf positive News...
am wochenende kommen die daten raus(konferenz in madrid)am montag zweistellig oder tempotaschentuch..
Antwort auf Beitrag Nr.: 47.874.365 von androlyt am 25.09.14 15:11:09Ok, Aktie heute im Plus. Mal sehen was sie morgen macht. Wenn sie weiter steigt könnte jemand schon was wissen. Mir ist es zu heiß weiter zu kaufen. Ich warte lieber mal ab und stocke auf wenn die Daten gut sind.
Wenn Daten raus sind zu Lungenkrebs und positiv wird's wenig sinn machen..wird ein ordentlichen Kurssprung geben,100% und mehr locker drin!wenn nicht dann vermutlich knapp unter 6usd.also ich werde heute welche nachfkaufen,Kursniveau noch günstig..
eben nachgekauft zu 7,21usd,wird wahrscheinlich ein bisschen hektisch-berg und talfahrt..egal..mal schauen was am wochende rauskommt bzw. montag..drück uns und allen anderen investierten die daumen..
Antwort auf Beitrag Nr.: 47.885.909 von androlyt am 26.09.14 15:51:55jetzt hat gerade einer 48935stk gekauft:eek
nasdaq)
nasdaq)
Antwort auf Beitrag Nr.: 47.886.539 von androlyt am 26.09.14 16:42:43Endocyte: Phase-2b-Studie Resultate anzeigen TARGET verbesserten Überleben bei NSCLC Patienten
RELATED NEWS
Endocyte Inc. (ECYT) brach in ein 4-Monats-Hoch
Endocyte Inc. (ECYT) hat sich auf über ein 4-Monatshoch geklettert
Endocyte Um Anwesend bei Baird 2014 Health Care Conference; Webcast, um 2:20 Uhr ET
Endocyte Q2 14 Earnings Conference Call um 4:30 Uhr ET
Handel jetzt mit ECYT
2014.09.27 10.31 Uhr ET
Endocyte, Inc. (ECYT: Quote) Annonce kleines Molekül als Wirkstoff, der das Gold-Konjugat in Kombination mit Docetaxel SMDC vintafolide Overalls verlängert Überlebenszeit für Patienten mit OS oder Folat-Rezeptor-positiven oder FR wiederkehrenden nicht-kleinzelligem Lungenkrebs oder NSCLC Patienten, senden Verglichen mit Monotherapie Docetaxel in Phase-2b-Studie TARGET ict. Die brandaktuelle Studie TARGET Daten an die vorgestellte Möchten Europäischen Gesellschaft für Medizinische Onkologie ESMO-Kongress oder durch Rohit Lal, MD, Berater Onkologe am Guys and St Thomas 'Hospital und Ehren Consultant Medical Oncologist Jahr für Kings College Hospital, London.
Die Daten zeigen, dass Patienten mit Adenokarzinom in der vordefinierten Untergruppe mit der Kombination vintafolide plus Docetaxel behandelt wurden, hatten eine 27-prozentige Reduktion des Risikos der Verschlechterung der Krankheit oder Tod, und eine 30-prozentige Reduktion des Risikos des Todes im Vergleich zu Docetaxel-Monotherapie.
Rohit Lal sagte: "Diese Ergebnisse sind sehr vielversprechend für Patienten, die schicken Second-Line-Behandlung für diese anspruchsvolle Krankheit. Folatrezeptor Das ist ein vielversprechendes Ziel, vor allem in nicht-kleinzelligem Lungenkrebs, wobei die majorité der Patienten sind positiv für diesen Rezeptor. Insbesondere die Konsistenz Unter den Patienten mit Adenokarzinom Ergebnisse, einschließlich der Verbesserung der Tumoransprechrate, verzögerte Krankheitsprogression und Überleben erweiterte Overalls, mittel Fortsetzung Studie dieser Patientenpopulation in vintafolide. "
In die Studie wurden 199 Patienten behandelt und wieder, die alle Ziel Tumoren positiv für die Folat-Rezeptor, wie mit dem Begleiter Bildgebungsmittels etarfolatide bestimmt. Wurden die Patienten randomisiert Betweens drei Arme: vintafolide Monotherapie, eine Kombination von vintafolide und Docetaxel, und Docetaxel-Monotherapie.
Endocyte: Phase-2b-Studie Resultate anzeigen TARGET verbesserten Überleben bei NSCLC PatientenRELATED NEWS
Endocyte Inc. (ECYT) brach in ein 4-Monats-Hoch
Endocyte Inc. (ECYT) hat sich auf über ein 4-Monatshoch geklettert
Endocyte Um Anwesend bei Baird 2014 Health Care Conference; Webcast, um 2:20 Uhr ET
Endocyte Q2 14 Earnings Conference Call um 4:30 Uhr ET
Handel jetzt mit ECYT
2014.09.27 10.31 Uhr ET
Endocyte, Inc. (ECYT: Quote) Annonce kleines Molekül als Wirkstoff, der das Gold-Konjugat in Kombination mit Docetaxel SMDC vintafolide Overalls verlängert Überlebenszeit für Patienten mit OS oder Folat-Rezeptor-positiven oder FR wiederkehrenden nicht-kleinzelligem Lungenkrebs oder NSCLC Patienten, senden Verglichen mit Monotherapie Docetaxel in Phase-2b-Studie TARGET ict. Die brandaktuelle Studie TARGET Daten an die vorgestellte Möchten Europäischen Gesellschaft für Medizinische Onkologie ESMO-Kongress oder durch Rohit Lal, MD, Berater Onkologe am Guys and St Thomas 'Hospital und Ehren Consultant Medical Oncologist Jahr für Kings College Hospital, London.
Die Daten zeigen, dass Patienten mit Adenokarzinom in der vordefinierten Untergruppe mit der Kombination vintafolide plus Docetaxel behandelt wurden, hatten eine 27-prozentige Reduktion des Risikos der Verschlechterung der Krankheit oder Tod, und eine 30-prozentige Reduktion des Risikos des Todes im Vergleich zu Docetaxel-Monotherapie.
Rohit Lal sagte: "Diese Ergebnisse sind sehr vielversprechend für Patienten, die schicken Second-Line-Behandlung für diese anspruchsvolle Krankheit. Folatrezeptor Das ist ein vielversprechendes Ziel, vor allem in nicht-kleinzelligem Lungenkrebs, wobei die majorité der Patienten sind positiv für diesen Rezeptor. Insbesondere die Konsistenz Unter den Patienten mit Adenokarzinom Ergebnisse, einschließlich der Verbesserung der Tumoransprechrate, verzögerte Krankheitsprogression und Überleben erweiterte Overalls, mittel Fortsetzung Studie dieser Patientenpopulation in vintafolide. "
In die Studie wurden 199 Patienten behandelt und wieder, die alle Ziel Tumoren positiv für die Folat-Rezeptor, wie mit dem Begleiter Bildgebungsmittels etarfolatide bestimmt. Wurden die Patienten randomisiert Betweens drei Arme: vintafolide Monotherapie, eine Kombination von vintafolide und Docetaxel, und Docetaxel-Monotherapie.
Antwort auf Beitrag Nr.: 47.892.200 von androlyt am 27.09.14 22:21:31Mhm, na ja. Also, alles in allem zeichnet es sich mehr und mehr ab, dass wirklich der gesamte technologische Ansatz gescheitert sein dürfte.
Das ist sehr, sehr schade. Als ich vor 3,5 Jahren auf das Unternehmen aufmerksam wurde, fand ich die Idee sehr spannend, ADCs auf SM-Basis zu bauen. Das hätte viele Vorteile gegenüber den mab-ADCs haben können. Aber es war ja dann ziemlich schnell klar, dass es in der Praxis der klinischen Entwicklung nicht gut aussah.
Es kann eben nicht alles funktionieren...
Das ist sehr, sehr schade. Als ich vor 3,5 Jahren auf das Unternehmen aufmerksam wurde, fand ich die Idee sehr spannend, ADCs auf SM-Basis zu bauen. Das hätte viele Vorteile gegenüber den mab-ADCs haben können. Aber es war ja dann ziemlich schnell klar, dass es in der Praxis der klinischen Entwicklung nicht gut aussah.
Es kann eben nicht alles funktionieren...
Antwort auf Beitrag Nr.: 47.894.117 von SLGramann am 28.09.14 17:26:54sehe es nicht so negativ,alles in allem war die studie erfolreich,auch wenn die daten nicht überragend sind..mal gespannt was die börse draus macht?
Antwort auf Beitrag Nr.: 47.894.117 von SLGramann am 28.09.14 17:26:54VOLLE ZUSTIMMUNG !
!
Dieser Beitrag wurde von CloudMOD moderiert. Grund: Spam, Werbung
bin heute eingestiegen und sehe bei dem heutigen Kursanstieg
eine positive Analyse der Studie!
eine positive Analyse der Studie!
Antwort auf Beitrag Nr.: 47.950.351 von hebbelman am 06.10.14 09:41:43Heute? Um die Uhrzeit? Das heißt ja wohl, dass Du in Deutschland gekauft hast.
Ich kann wirklich nicht verstehen, wie man so einen Wert an einem quasi umsatzlosen Börsenplatz kaufen kann!? Warum handelst Du so etwas denn nicht an der NASDAQ?
Aber das mal nur am Rande...
Ich kann wirklich nicht verstehen, wie man so einen Wert an einem quasi umsatzlosen Börsenplatz kaufen kann!? Warum handelst Du so etwas denn nicht an der NASDAQ?
Aber das mal nur am Rande...
Antwort auf Beitrag Nr.: 47.953.495 von SLGramann am 06.10.14 15:50:21Hallo,
Order läuft natürlich über die NASDAQ!
Order läuft natürlich über die NASDAQ!
Einstiegschance
Ich denke auf dem Niveau kann man hier mal einsteigen. Der TARGET Trial mit Vynfinit hat die Erwartungen erfüllt. Im 2. Halbjahr stehen noch vielversprecgende Phase 1 updates mit Tubulysin an. Weitere Krebsmedikamente in der Pipeline und noch über 200 Mio $ in cash sollten den Kurs jetzt ein solides Fundament geben:Endocyte, Inc. (NASDAQ:ECYT) announced an encouraging interim update on overall survival (OS) of patients in a phase IIb study (TARGET) evaluating vintafolide (a small molecule drug conjugate, or SMDC) in combination with Taxotere for the treatment of folate receptor (FR) positive recurrent non-small cell lung cancer (NSCLC). The company is evaluating vintafolide as a second line treatment for patients suffering from NSCLC who have failed one prior line of therapy. On last trading day Endocyte, Inc. (NASDAQ:ECYT) advanced 4.01% to close at $5.97. ECYT is -82.28% away from its 52 week high and is moving 7.57% ahead of its 52 week low. Endocyte, Inc. (NASDAQ:ECYT) return on investment (ROI) is -20.70% while return on equity (ROE) is 11.20%.
Quelle: Wallstreet Scope
Boris Peaker (Oppenheimer) kommt mit einem "Buy" aus dem Sulki
http://investorwand.com/stock/2572/ecyt-endocyte-inc
...and provide an operational update.
Da sollte man noch vor dem 05.11. dabei sein!
Endocyte Announces Third Quarter 2014 Earnings Conference Call
October 29, 2014 16:01 ET | Source:Endocyte, Inc.
WEST LAFAYETTE, Ind., Oct. 29, 2014 (GLOBE NEWSWIRE) -- Endocyte, Inc., (Nasdaq:ECYT) announced today that the company will host a conference call on Wednesday, Nov. 5, at 4:30 p.m. EST to discuss its third quarter 2014 financial results and provide an operational update.
Investors and the general public are invited to listen to a live webcast of the call, which can be accessed in the Investors & News section of the Company's website at www.endocyte.com or by dialing (877) 845-0711 (U.S./Canada) or (760) 298-5081 (International).
The webcast will be recorded and available on the Company's website for one week following the call.
Da sollte man noch vor dem 05.11. dabei sein!
Endocyte Announces Third Quarter 2014 Earnings Conference Call
October 29, 2014 16:01 ET | Source:Endocyte, Inc.
WEST LAFAYETTE, Ind., Oct. 29, 2014 (GLOBE NEWSWIRE) -- Endocyte, Inc., (Nasdaq:ECYT) announced today that the company will host a conference call on Wednesday, Nov. 5, at 4:30 p.m. EST to discuss its third quarter 2014 financial results and provide an operational update.
Investors and the general public are invited to listen to a live webcast of the call, which can be accessed in the Investors & News section of the Company's website at www.endocyte.com or by dialing (877) 845-0711 (U.S./Canada) or (760) 298-5081 (International).
The webcast will be recorded and available on the Company's website for one week following the call.
charttechisch siehts mal wieder gut aus,mal sehen ob sie ausbricht..
kann man fast jeden handelstag beobachten,kaum gestiegen schon zusammengefallen wie ein kartenhaus..macht einfach kein spass mehr..
endocyte du elendes stück sch..
Hi an Alle,
Überlege hier mit einzusteigen
bin über das BB Biotech Portotfolio darauf aufmerksam geworden, habe aktuell aber keine Daten über deren Anteil daran!
is wohl very risky der Titel ! wobei MK und Cash aktuell fast pari sind
Muss mal den cashburn noch finden, denn die so haben
Falls sich die Technologie aber doch als hilfreich erweisen sollte,
gehts hier ab!
Werde immer auch BB Biotech im Auge behalten!
anbei mal eine ältere Meinung aus Stockhouse
http://www.stockhouse.com/companies/bullboard/ecyt/endocyte-…
und eine neuer Artikel aus SA
http://seekingalpha.com/article/2864186-endocyte-small-compa…
Endocyte: Small Company, Small Valuation, Full Pipeline
Jan. 29, 2015 1:22 PM ET | About: Endocyte, Inc. (ECYT)
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
Summary
• Endocyte's cancer treatment offers big potential for investors willing to wait and take a chance.
• The company's SMDC is an innovative technology that could change the efficacy of many chemotherapy drugs that exist today.
• The oncology market is projected to reach $110 billion by 2018, any sliver of this market for Endocyte could be monumental for this small-cap company.
• Endocyte has a bolus of products in the pipeline, of which many of them could produce strong revenues.
• Endocyte is currently valued at about $220 million. As of the third-quarter 2014, the company had $211.4 million in cash/equivalents. Investors can buy the future revenue for free.
Background
Endocyte, Inc. (NASDAQ:ECYT) is a biopharmaceutical company based out of West Lafayette, IN. The company is currently developing therapies that target both cancers and inflammatory diseases. Endocyte's technology uses small molecule drug conjugates (SMDCs) in combination with imaging diagnostics. Endocyte currently has several SMDCs in clinical trials at various stages. This article will offer up an overview of the company as well as the potential of the pipeline. Endocyte does not appear to be interested in manufacturing new drugs; rather it is looking at improving the efficacy of drugs already available by targeting the treatment.
Small Molecule Drug Conjugates
SMDCs have three components, a targeting ligand, linker and the drug payload. The targeting ligand is a small molecule that has a high affinity for binding to a receptor on the target, most often a cell. The target ligand allows for targeting specific cells, such as cancer cells. The linker is a system that is stable in the bloodstream which binds the targeting ligand to an additional agent. The additional agent could be the drug/therapy or a reagent used for imaging. The linker can be customized to allow for combining different drugs or imaging agents to improve effectiveness based on the target. The drug payload is the biologically-active component of the conjugate.

The image was retrieved from the Endocyte website offering what a potential SMDC looks like.
By replacing the drug payload with a radioisotope that can be visualized using various pieces of equipment, Endocyte is able to determine, early in drug development, how specific the ligand is to the target. Additionally, once this technology reaches the clinical field, a physician can use the SMDC with the imaging ligand prior to treating with an SMDC with a drug payload. By confirming the target prior to treatment, an oncologist will be reassured the drug is targeting the tumor cells and not healthy cells.
Increase Potency with Decreased Doses
Through in vitro analysis, Endocyte has shown drug payloads that are attached to SMDCs can be thousands of times more potent than traditional methods using the same drug payload untargeted. Going one step further, Endocyte in some instances uses a drug payload that would be too toxic if being administered untargeted. What this means is that the amount of drug needed, untargeted, would kill the patient before reaching the dose needed to be equal to a therapeutic dosage. Taking this one step further, the potential to increase the potency of a drug without the concern of killing healthy cells may be realized. Previous drugs that were too toxic to the patient could be revisited, thanks to the ability to target specific cells.
Gruss S.
Überlege hier mit einzusteigen
bin über das BB Biotech Portotfolio darauf aufmerksam geworden, habe aktuell aber keine Daten über deren Anteil daran!
is wohl very risky der Titel ! wobei MK und Cash aktuell fast pari sind
Muss mal den cashburn noch finden, denn die so haben
Falls sich die Technologie aber doch als hilfreich erweisen sollte,
gehts hier ab!
Werde immer auch BB Biotech im Auge behalten!
anbei mal eine ältere Meinung aus Stockhouse
http://www.stockhouse.com/companies/bullboard/ecyt/endocyte-…
und eine neuer Artikel aus SA
http://seekingalpha.com/article/2864186-endocyte-small-compa…
Endocyte: Small Company, Small Valuation, Full Pipeline
Jan. 29, 2015 1:22 PM ET | About: Endocyte, Inc. (ECYT)
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
Summary
• Endocyte's cancer treatment offers big potential for investors willing to wait and take a chance.
• The company's SMDC is an innovative technology that could change the efficacy of many chemotherapy drugs that exist today.
• The oncology market is projected to reach $110 billion by 2018, any sliver of this market for Endocyte could be monumental for this small-cap company.
• Endocyte has a bolus of products in the pipeline, of which many of them could produce strong revenues.
• Endocyte is currently valued at about $220 million. As of the third-quarter 2014, the company had $211.4 million in cash/equivalents. Investors can buy the future revenue for free.
Background
Endocyte, Inc. (NASDAQ:ECYT) is a biopharmaceutical company based out of West Lafayette, IN. The company is currently developing therapies that target both cancers and inflammatory diseases. Endocyte's technology uses small molecule drug conjugates (SMDCs) in combination with imaging diagnostics. Endocyte currently has several SMDCs in clinical trials at various stages. This article will offer up an overview of the company as well as the potential of the pipeline. Endocyte does not appear to be interested in manufacturing new drugs; rather it is looking at improving the efficacy of drugs already available by targeting the treatment.
Small Molecule Drug Conjugates
SMDCs have three components, a targeting ligand, linker and the drug payload. The targeting ligand is a small molecule that has a high affinity for binding to a receptor on the target, most often a cell. The target ligand allows for targeting specific cells, such as cancer cells. The linker is a system that is stable in the bloodstream which binds the targeting ligand to an additional agent. The additional agent could be the drug/therapy or a reagent used for imaging. The linker can be customized to allow for combining different drugs or imaging agents to improve effectiveness based on the target. The drug payload is the biologically-active component of the conjugate.

The image was retrieved from the Endocyte website offering what a potential SMDC looks like.
By replacing the drug payload with a radioisotope that can be visualized using various pieces of equipment, Endocyte is able to determine, early in drug development, how specific the ligand is to the target. Additionally, once this technology reaches the clinical field, a physician can use the SMDC with the imaging ligand prior to treating with an SMDC with a drug payload. By confirming the target prior to treatment, an oncologist will be reassured the drug is targeting the tumor cells and not healthy cells.
Increase Potency with Decreased Doses
Through in vitro analysis, Endocyte has shown drug payloads that are attached to SMDCs can be thousands of times more potent than traditional methods using the same drug payload untargeted. Going one step further, Endocyte in some instances uses a drug payload that would be too toxic if being administered untargeted. What this means is that the amount of drug needed, untargeted, would kill the patient before reaching the dose needed to be equal to a therapeutic dosage. Taking this one step further, the potential to increase the potency of a drug without the concern of killing healthy cells may be realized. Previous drugs that were too toxic to the patient could be revisited, thanks to the ability to target specific cells.
Gruss S.
hab den Gedanken wieder verworfen
BB Bio hat glaub ich aktuell keine ANteile mehr
lt Web Sidehttp://www.bbbiotech.ch/de/bb-biotech/strategie-portfolio/po…
gibt grad x interessantere Werte finde ich
Bin dann weg
Gruss S.
BB Bio hat glaub ich aktuell keine ANteile mehr
lt Web Sidehttp://www.bbbiotech.ch/de/bb-biotech/strategie-portfolio/po…
gibt grad x interessantere Werte finde ich
Bin dann weg
Gruss S.
Hallo alle zusammen, der letzte Beitrag ist schon länger her sehe ich gerade. Mein Einstieg liegt bei 10.05 $ . PT : 12-14$ . GLTA.
Bin hier seit 3$ dabei. Bin fest davon überzeugt, dass hier ein ganz großer Player in der Krebsforschung und Behandlung aufgebaut wird. Die Pipeline ist vielversprechend und da sich die grossen biotechs im Moment selbst schwer tun ( jedenfalls die meisten US biotechs) ist auch eine Übernahme ein nicht ganz unrealistisches Szenario.
Swing Pick Ziel bereits erreicht. Gesamte Position verkauft. Neuer Swing für diese Woche ist SGYP. Entry: 1.84 PT : 2.15-2.75. SL: 1.65 +/- 5 Cent. Zeit bis zum erreichen des Ziel : ca eine Handelswoche GLTA
Antwort auf Beitrag Nr.: 57.707.842 von Antropophagi am 07.05.18 11:48:53
Ich bin zwar auch dabei...
doch halte ich es bei Biopharma-Aktien für angebracht, Aktien von einigen Firmen zu halten, denn ob die Forschungsergebnisse schlussendlich erfolgreich sind --- das ist immer sehr schwer vorher zu sagen und heikel.Zitat von Antropophagi: Bin hier seit 3$ dabei. Bin fest davon überzeugt, dass hier ein ganz großer Player in der Krebsforschung und Behandlung aufgebaut wird. Die Pipeline ist vielversprechend und da sich die grossen biotechs im Moment selbst schwer tun ( jedenfalls die meisten US biotechs) ist auch eine Übernahme ein nicht ganz unrealistisches Szenario.
Antwort auf Beitrag Nr.: 58.988.130 von Antropophagi am 18.10.18 07:24:51Geplante übernahme von novartis zu 24$
Antwort auf Beitrag Nr.: 49.121.150 von Schaeffi am 19.02.15 19:11:19
Tja das war wohl ein Fehler von mir.
damals noch für unter 5 zu haben
Zeitweise auch durchs Tal der Tränen bis auf 1,1x € runter gegangen und dann von einem Tag auf den Andern --->wie Phönix aus der Asche.
und jetzt das BO
Gratulation an alle Looongs
So ist Börse - insbesondre bei Biotechs.
S.
Zitat von Schaeffi: hab den Gedanken wieder verworfen
BB Bio hat glaub ich aktuell keine ANteile mehr
lt Web Sidehttp://www.bbbiotech.ch/de/bb-biotech/strategie-portfolio/po…
gibt grad x interessantere Werte finde ich
Bin dann weg
Gruss S.
Tja das war wohl ein Fehler von mir.
damals noch für unter 5 zu haben
Zeitweise auch durchs Tal der Tränen bis auf 1,1x € runter gegangen und dann von einem Tag auf den Andern --->wie Phönix aus der Asche.
und jetzt das BO
Gratulation an alle Looongs
So ist Börse - insbesondre bei Biotechs.
S.
Antwort auf Beitrag Nr.: 58.996.794 von Schaeffi am 18.10.18 19:57:05Du hast auf jeden fall mein beileid, meinen dank und ein paar bierchen von mir sicher 😁
Ist doch theoretisch auch noch ein bieter wetzstreit möglich oder ?
Antwort auf Beitrag Nr.: 58.996.839 von Antropophagi am 18.10.18 20:02:35Möglich ist das.
und danke für die Bierchen
S
und danke für die Bierchen
S
Ich will mehr davon😬😂
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