BioSante Pharmaceuticals (BPAX) announced Monday that the FDA's clinical hold on the GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been lifted by FDA, but will that news be enough to get investors to buy-in and hold on to shares?
In May of last year, the company announced that the treatment of prostate cancer has been reinitiated and that manufacturing of new GVAX Prostate was in process. Regulatory steps to lift the GVAX Prostate clinical hold prior to trial initiation had been taken at that time, and prostate cancer patients were expected to be treated in a Phase II human clinical trial beginning in the fourth quarter of 2010.
This week the company said that manufacturing of new GVAX Prostate is complete, and planning for a Phase II clinical trial at the Johns Hopkins Kimmel Cancer Center is still underway.
While it is not immediately clear what the impact of the news will be to investors given the fact that GVAX has had a rocky history, the traction for higher valuation of the company may not stick until there is actual clinical data and further regulatory progress for GVAX.
BioSante does point out, however, that it continues to believe in the vaccine and that the company funded the manufacturing of GVAX Prostate; whose trial will be supported in part by the Prostate Cancer Foundation. That is a nice nod for the efforts from the world's largest philanthropic source of support for accelerating the world's most promising research for discovering better treatments and cures for prostate cancer. In addition, the company said important start-up funding for this study was provided by the OneInSix Foundation.
"The Prostate Cancer Foundation funded the early work at Johns Hopkins University that resulted in the development of the GVAX Prostate Cancer Vaccine. We are pleased to continue support of Dr. Charles Drake and his innovative clinical and laboratory investigations of GVAX at Hopkins," said Howard R. Soule, PhD, executive vice president and chief science officer of the Prostate Cancer Foundation. "We are delighted that the OneInSix Foundation has joined in support of this important prostate cancer program. Under BioSante leadership we are hopeful that GVAX Prostate will be established as a new treatment for men with advanced prostate cancer."
"We are pleased to be working with Johns Hopkins as well as the Foundations on such an important project," said Stephen M. Simes, BioSante's president and chief executive officer. "A joint effort among the various parties involved has resulted in the FDA lifting the GVAX Prostate clinical hold which is a positive step for development of a new prostate cancer vaccine and the men who may benefit. Now that the FDA has approved the first-ever therapeutic cancer vaccine, Provenge, for the treatment of prostate cancer, we have renewed confidence that GVAX Prostate can be a valuable addition to prostate cancer patient care."
There are marked differences between the recently approved Provenge treatment of prostate cancer from Dendreon (NASDAQ:DNDN). Provenge requires isolation of cells from the patient that are then modified to produce the vaccine which is then re-introduced into the patient, Biosante officials say GVAX Prostate is an off-the-shelf, non-patient-specific vaccine. It is comprised of prostate cancer cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety.
BioSante has several other cancer vaccines which are in Phase II clinical development including vaccines for leukemia, breast cancer and pancreatic cancer.
To date, Dendreon's Provenge is the only immunotherapy cancer vaccine treatment which has made it past all of the FDA's regulatory hurdles. Several companies have late-stage drug candidates in the race, among them are ImmunoCellular (NYSEMKT:IMUC) and Northwest Biotherapeutics (NASDAQ:NWBO).
ImmunoCellular reported last week that it would be presenting new data from the Phase 1 study at ASCO in Chicago via an abstract titled, “Glioma-associated antigens associated with prolonged survival in a phase I study of ICT-107 for patients with newly diagnosed glioblastoma.” It is expected that the abstract will show that there is a correlation between the immunological response that ICT-107 generated in the form of antigens and both progression-free and overall survival, and that these observations suggest that targeting antigens highly expressed by cancer stem cells (CSCs) is a promising strategy for treating patients with glioblastoma. Shares of IMMUC have reversed course, but will have to keep trading above the $2 mark and continue to see volume activity if the company is to realize its hopes of getting uplisted to a big board exchange.
Anyone with real knowledge of these platforms will tell you that the science at both of these firms is solid, but will investors continue to buy into the promise of it?
For its part, Northwest Biotherapeutics has announced that its program just received a boost from news of its partnering with Fraunhofer - the largest applied research foundation in Europe - for production of its DCVax-L for brain cancer, for clinical trials and for compassionate use cases in Europe. Also the company said recently that the program has received key funding through a series of financing arrangements for its ongoing late-stage 240-patient clinical trial of DCVax-L for the treatment of Glioblastoma multiforme (GBM) brain cancer.
Over the weekend, NWBO told investors that the new funding - which includes a $3 million investment it had already received and access of up to $25 million of further funding on fixed, specified and favorable terms - will provide a strong financial foundation for completion of that key study but will also provide for certain other programs in NWBO's near term pipeline.
Recently, after we told our readers that Northwest's partnering news was quite significant in several ways, shares of the company more than doubled in value. We plan to examine more closely how these newly announced financings may be just what the doctor ordered for NWBO, particularly given how badly the pundits have bashed NWBO for not ever having enough funding to pushits pipeline in the past. Stay tuned for that report.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.