Favrille failure puts pressure on other cancer vaccines

Analysis

Favrille has joined the growing ranks of companies developing cancer vaccines who have failed to prove conclusively that their drug works. The failure of SpecifId will be a blow to others in the field given its role as the poster boy for the industry. It was one of the most advanced candidates in development and one of the very few with sales forecasts.

Its lack of efficacy also means that Favrille, which has few other candidates in its pipeline, is almost certainly staring down the barrel of bankruptcy. Yesterday, shares in the California-based company shed 86% of their value, finishing the day at 22 cents.

While it will be little comfort to Favrille shareholders, the notorious difficulty in dragging a cancer vaccine to market is reflected by the sheer number of projects that have been abandoned in R&D, which now totals 132, according to EvaluatePharma. 

Market Status Cancer Vaccines Product Count
   
 Marketed  4
 Filed  1
 Phase III  15
 Phase II  24
 Phase I  15
 Pre-clinical  41
 Research project  4
 Suspended in R&D  4
 Abandoned in R&D*  132
Total 240

* Includes SpecifId failure

The most recent victim was Genitope, which back in December announced the failure of its phase III trial for MyVax, causing its shares to drop 70% on the day.

There has, however, been one success story of a kind in the sector. Back in April Antigenics announced it was about to start marketing its renal cancer drug Oncophage. But some of the shine of the achievement was removed when it was revealed that the vaccine, which has so far failed to get US approval, was being sold in Russia.

With SpecifId, which once had analysts optimistically pencilling in sales of $445m, now almost certain to be consigned to the dustbin of history, upcoming data for the remaining contenders will be eagerly awaited for signs that therapeutic vaccines are not just a fantasy.

Positive data needed

Analysts have only assigned sales forecasts to four of the phase III candidates, and many have been downgraded, as doubts that any will reach the market have escalated.

In the 12 months ended April, estimates of 2012 sales for Merck KGaA’s Stimuvax have fallen from $183m to $67m. Prior to its disappointment, SpecifId had taken a big hit in the same period, dropping from $501m to $184m.

Dendreon, with its prostate cancer shot Provenge, will be the next company to run the trial gauntlet when it reports the interim findings of its IMPACT study, which are expected in the next four weeks.

The company will be hoping that Provenge comes up with impressive data, given that some analysts have started to talk up the potential of its nearest rival GVAX Prostate, developed by Cell Genesys. Analysts have forecasts for Provenge of $162m by 2012, which is expected to present a full read out of the phase III data by the second half of 2009.

There are no sales forecasts for GVAX Prostate as yet, but back in March Cell Genesys received a more solid form of endorsement when Japan’s Takeda signed a deal worth up to $320m to take on the world-wide commercialisation rights to the product.

GVAX Prostate differs from many of the other cancer vaccines on the market in that the cells from the patients tumour are not required to make a vaccine, meaning it is not only cheaper than other alternatives, but can be used in a number of patients.

Cell Genesys and Takeda, however, are not expected to report any significant phase III data before the first half of 2009, when there could be interim data from the VITAL-2 trial, which uses GVAX Prostate with chemotherapy, against chemotherapy alone. More importantly, full data will be available from the group’s VITAL-1 trial, comparing the drug with chemotherapy, in the second half of 2009.

First to market

Its time frame of reporting results mean that if things go well both Dendron and BiovaxID, the treatment for Non-Hodgkin’s Lymphoma from Accentia Biopharmaceuticals, could be on the market ahead of GVAX. Accentia is looking to file an NDA with the FDA by the fourth quarter of this year following the end of clinical trials in late August.

Oxford BioMedica’s TroVax could also join GVAX in entering the market in 2010. It is not due to report the final data from its phase III TRIST study until mid 2009 at the very earliest.

But given the track record of cancer vaccines, until one of them does come up with robust, conclusive phase III data, talking about launch dates could still be a case of counting your chickens before they are hatched.

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