Biotech Values

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New Cancer Vaccine the Next Dendreon?

http://www.thestreet.com/story/10743730/1/the-next-dendreon-not-likely.html

Adam Feuerstein 05/03/10 - 01:03 PM EDT

BOSTON (TheStreet) -- Think all cancer vaccines are, or will be, successful? Think again.

Before there was Dendreon(DNDN) and its just-approved prostate cancer vaccine Provenge, there was Cell Genesys and Favrille, CancerVax and Genitope(GTOP.PK). All tried to develop cancer vaccines, all failed.

Dendreon's stock price is surging; those other four cancer vaccine companies -- not so much. Favrille and CancerVax are no longer with us. Genitope exists in pink sheet purgatory. Only Cell Genesys managed to survive, sort of, by selling itself to BioSante Pharmaceuticals(BPAX), a small drug company better known for trying to develop a female Viagra.

Dendreon is a great success story and proves that patience and perseverance can pay off in the fledgling field of cancer immunotherapy. But let's not also forget that Dendreon is a lonely winner surrounded by a crowd of cancer vaccine losers.

In the next weeks and months, investors are going to be enticed by drug companies crawling out of the woodwork with claims that they're working on the next Provenge. That's an easy thing to say, much tougher to actually accomplish.

Biotech investors are busy looking for the "next Dendreon." Nothing wrong with searching for new cancer vaccines, as long as investors remember that, once upon a time, some other investors bought Favrille and Genitope, CancerVax and Cell Genesys confident that they already owned the next Dendreon.

It didn't quite work out that way, unfortunately.

On Monday, BioSante said it was resurrecting the GVAX prostate cancer vaccine program that caused Cell Genesys to blow up in 2008.

Too new to the cancer vaccine game to remember what happened to Cell Genesys and GVAX? Here's a quick history lesson. Independent data safety monitors in August 2008 forced Cell Genesys to shutter one phase III clinical trial of GVAX because prostate cancer patients treated with GVAX and chemotherapy were dying at a faster rate than those patients treated with chemotherapy alone.

Cell Genesys stopped the second and final GVAX phase III study in October 2008 due to futility, meaning GVAX was deemed too ineffective to benefit prostate cancer patients.

GVAX was doomed from the start because data from phase II studies of the cancer vaccine were fairly lousy. Of course, that didn't stop Cell Genesys from signing a partnership with the Japanese drug maker Takeda, or for investors who thought they knew better to lose all their money when Cell Genesys' stock price sank to mere pennies.

Hope apparently springs eternal in the Provenge post-approval era.

"Now that the FDA has approved the first-ever therapeutic cancer vaccine, Provenge, for the treatment of prostate cancer, we have renewed confidence that our GVAX Prostate can be a valuable addition to prostate cancer patient care," said BioSante CEO Stephen Simes in Monday's press release.

Nice touch, linking Provenge and GVAX.

Antigenics(AGEN) and its cancer vaccine Oncophage is a two-time loser, having failed phase III studies in melanoma and kidney cancer.

Antigenics did manage to secure Oncophage's approval in Russia in 2008, although it took until this year for a single Russian patient to actually pay for treatment with the drug. European regulators rejected Oncophage in 2009 and the clinical data from phase III studies and post-hoc survival registries is of such low quality that Antigenics can't even approach the U.S. Food and Drug Administration about seeking approval here.

Antigenics continues to pursue Oncophage's development, with data from a phase II brain tumor study expected later this year.

Overall, a dozen experimental cancer vaccine programs have failed phase III studies, according to a list compiled by MD Becker Partners as part of an in-depth cancer vaccines report published recently by the biotech consulting firm.

MD Becker Partners' principal Michael Becker, in his report, identifies two main reasons for why cancer vaccines have a historically high failure rate. First, companies rushed cancer vaccines into the human testing without understanding how they worked on a molecular level. As a result, many early cancer vaccines lacked potency and were unable to provoke an immune response strong enough to fight off tumor cells.

Second, drug companies tried to develop cancer vaccines on the cheap. Instead of spending money on robust mid-stage studies to winnow out potential winners from the losers, companies moved quickly into large, high-risk phase III studies, he says.

Cel-Sci(CVM) is expected to start a phase III study of its cancer vaccine Multikine in head and neck cancer patients this summer, despite limited and relatively weak data from phase II studies.

Two more cancer vaccine stocks investors should regard with caution: Northwest Biotherapeutics(NWOB.OB) and its brain cancer vaccine DCVax; and BioVest International(BVTI.PK), developer of BiovaxID for non-Hodgkin's lymphoma.

[BioVest and its companion company Accentia Pharmaceuticals presented phase III data on BiovaxID at the plenary session of last year's American Society of Clinical Oncology annual meeting. Yet the companies have yet to seek regulatory approval for the drug.]

Think you have the next Dendreon of the cancer vaccine world? The odds say you don't.