|Emerging cancer vaccines keep vying for attention from investors|
|Monday, 06 June 2011 07:29|
Today 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 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 may not occur 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 ans 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.
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 (OTCBB:IMUC) and Northwest Biotherapeutics (OTCBB: NWBO).
For their part, Northwest Biotherapeutics has announced that their program has just received a boost not only news of their partnering with Fraunhofer-- the largest applied research foundation in Europe, for production of their DCVax®-L for brain cancer, for clinical trials and for compassionate use cases in Europe-- but most recently that the program has received key funding through a series of financing arrangements for it's 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 to 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.