News that GlaxoSmithKline (NYSE:GSK) DERMA study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3 cancer immunotherapeutic trial for melanoma has missed its primary endpoint, has caused a selloff in Agenus (NASDAQ:AGEN) stock. The reason for investors' rush to sell AGEN was that the vaccine contains Agenus'QS-21 Stimulon®adjuvant.
Most probably, the selling of the good stock was a mindless reflex reaction that has nothing to do with the facts about the firm's adjuvant and immunotherapeutic programs in general. Nothing wrong has happened that can debase them. Agenus'QS-21 Stimulon® is one of two adjuvants considered the most effective in guiding the immune system towards attacking a specific target be it cancer or infective organisms by turning a week antigen in the target into an immunogen. As a matter of fact, GSK has decided upon considering it a component of its novel adjuvant system AS15. GSK is using it in many of its preventive and therapeutic vaccines.
Investors' negative reaction was caused by the fact that their eyes have well fallen on the sentence in a GSK press release stating the DERMA study did not meet its first co-primary endpoint. The vaccine did not significantly extend the disease-free survival (DFS) period when compared to placebo in the overall MAGE-A3 positive trial population. With their rush to sell the good stock, investors' eyes failed to fall on the sentence stating that the Independent Data Monitoring Committee (IDMC) has unanimously recommended GSK to continue the study until the assessment of the second co-primary endpoint.
The unmet co-primary endpoint is based "on predefined criterion that was agreed upon by regulatory authorities. If further analysis demonstrates that the predefined gene signature subset data are successful, there is the potential that a regulatory filing could be considered. "Until the availability of the data will be unveiled, GSK will remain blinded to all safety and efficacy data."
In other words, the study has not failed and the unmet endpoint of significantly extending the disease-free survival period compared to placebo is not sufficient to fail the vaccine. This is especially true when considering the fact that the medical community began to recognize the fact that, unlike chemotherapy and targeted drugs, which act early following treatments. Immunotherapeutics take long to demonstrate their efficacy in improving tumors' statuses, which in the long-term would be reflected in prolonging overall survival.
That's why the IDMC for the DERMA study decided that "the current review of the safety information raised no concern for the continuation of the trial."
"We continue to believe that cancer immunotherapeutics have the potential to deliver significant benefits to patients and we look forward to the analysis of gene signature data," said Garo H. Armen, Ph.D., chairman and CEO of Agenus Inc. "In the near future, we expect to report results of several other QS-21 Stimulon adjuvant containing programs."
QS-21 Stimulon adjuvant is a key component of many vaccines currently in clinical development by Agenus and by other companies that sublicensed the use of Stimulon. Besides the importance of Stimulon as an adjuvant, Agenus' pipeline of immunotherapeutics is based on advanced technologies and new approaches towards empowering the immune system in attacking cancer and infection.
Many catalysts are expected in upcoming reporting on Agenus' pipeline products' clinical trial results, including:
- Phase 2 data for HerpV, Agenus'QS-21 Stimulon containing investigational therapeutic vaccine for genital herpes, during the fourth quarter of 2013,
- GSK's Phase 3 results from MAGRIT, the MAGE-A3 non-small cell lung cancer (NSCLC) clinical trial in early 2014,
- GSK RTS,S program for the prevention of malaria. Positive results from this vaccine and its FDA approval, if materialize, will set a historical precedent for malaria, part of its success will be accredited to QS-21 Stimulon adjuvant owned by Agenus.
The big parts of beef, though will be in Prophage for recurrent glioblastoma owned totally by Agenus. This vaccine for the killer brain cancer has demonstrated promising results and is in trials. It is based on neat shock protein - a new technology based on totally and completely different technology used in preventive and therapeutic vaccines.
Promising data from investigator-sponsored studies have led to the recent initiation of a Phase 2 trial for recurrent glioblastoma. The trial is funded by the National Cancer Institute after being encouraged by previous results.
A large beefsteak is Agenus' HPV vaccine that differs from the available HPV vaccines in its therapeutic nature. Unlike the available anti-papilloma virus vaccine, which is approved only as a preventive vaccine, Agenus' HerpV vaccine is to be given to infected patients aiming at decreasing the possibility of contamination and probably, as a cure. Alliances, especially GSK, are working on dozens of preventive vaccines, in addition to therapeutic vaccines, most are in late phase trial.
(To learn more details about Agenus, Read past Prohost Letters)
We are long AGEN and we decided to take advantage of the ridiculous innovating firm's stock to accumulate the stock.
Disclosure: Long AGEN
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