Takeda backs Cell Genesys's cancer vaccine project

Cell Genesys has reaped the rewards of its research into the experimental field of therapeutic cancer vaccines, signing up Japanese major Takeda as development and commercialisation partner for its GVAX immunotherapy for prostate cancer.

The deal is the first significant partnership struck between a small drug developer and big pharma partner in the space, which still has many doubters. That Takeda sees potential provided some relief, and shares in the California company were trading 20% higher in morning trade.

The news provided a well needed boost to Cell Genesys stock, which has been drifting lower since April last year, despite a deal floating on the horizon. (See EP Vantage story Feb 20: Prospect of Cell Genesys deal lifts shares)

Takeda has paid $50m upfront and agreed to potential regulatory and commercialisation milestones worth up to $270m for worldwide rights to the vaccine candidate. Cell Genesys will also received tiered, double digit royalties on sales in the US, and flat double digit-royalties on sales elsewhere, and has retained the option to co-promote in the US.

Late stage trials

GVAX is currently in two phase III trials in patients with advanced prostate cancer, and has been grated fast track status by the FDA.

The first trial called Vital-1 completed enrolling 626 patients in July last year, and a final analysis should be available in the second half of 2009. The trial pits GVAX against chemotherapy drug Taxotere. Vital-2, GVAX in combination with Taxotere should complete enrolment in the first half of 2009, when an interim analysis could take place.

Many commentators believe the risk of the two Vital trials failing is high. Concerns about the robustness of previous GVAX trials have generated scepticism about success in the longer studies and pessimism about the therapeutic cancer vaccine space in general is fairly wide spread. (See EP Vantage story Mar 17: Cancer vaccines not immune to market scepticism.)

However, proponents argue that Cell Genesys’ novel “off the shelf” approach has greater potential than personalised therapeutic vaccines such as Dendreon’s Provenge, which are based on the individual patient’s own immune cells.

And while Dendreon tried to get Provenge through the FDA on the back of very small trials, Cell Genesys’ large studies should give a more definitive picture of efficacy to take to the regulator.

Validation

While the deal with Takeda does not guarantee those trials will be a success, it provides some comfort for the advocates of Cell Genesys, and therapeutic cancer vaccines to a certain extent. But until the trials report, large question marks will continue to hang over the product.

With more than a year to wait, it remains to be seen if the stock can maintain its newly elevated level.

At the very least, with Takeda shouldering the costs of the trials from now and the upfront payment on the deal, immediate financing concerns are removed. Cell Genesys was going to have to raise money this year, and the company would have found it hard to negotiate decent terms with the share price near record lows.

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