Cancer Vaccines have long been an area of promise in cancer research. And they have been an area of frustration for pharmaceutical and biotech companies. From negative clinical trial results to the FDA changing protocols mid-trial, it is a challenging time to be involved in the development of cancer vaccines.
Cell Genesys ended the trial of its GVAX candidate in prostate cancer back in August (see Cell Genesys Drops GVAX Trial ). Now, the company is shedding the majority of its workforce in a desperate bid to stay alive (see SF Chronicle ).
Sanofi-Pasteur is one of the largest companies engaged in cancer vaccine research. However, the Sanofi-Pasteur cancer vaccine initiative seems to have gone into deep hibernation and its ALVAC technology hasn’t gone anywhere in recent years. A new melanoma trial is underway, but it will be years Sanofi can evaluate whether the ALVAC technology will continue.
Oncophage from Antigenics has had mixed results, demonstrating increased media survival of four months (see Antigenics’ Oncophage Gets Mixed Results ). The product has been approved in Russia and now has an FDA export certificate, but Oncophage does not have regulatory approval in the U.S. or EU. Antigenics has filed for EU approval, so this is one to watch. I like Antigenics chances.
Finally, who could forget Dendreon? Their lead candidate Provenge received a resoundingly positive Advisory Committee endorsement, only to be torpedoed in a back room deal with the devil between Dr. Howard Scher and the FDA’s Richard Pazdur (see Can Provenge Get Any Weirder? ). The company has had to go back to the drawing board on the trial data. I believe Provenge will ultimately be approved, but it will take a long time because they FDA does not want to lose face in the way it has mishandled this review.
Cancer vaccines offer promise, but many challenges still remain.