Sanofi-Aventis has acquired a global license to develop and commercialize Oxford BioMedica's therapeutic cancer vaccine TroVax , the company said March 28. The announcement comes one day ahead of an FDA advisory committee review for Dendreon's Provenge , the first therapeutic cancer vaccine to be accepted for review by the agency.

In a deal that could be valued at nearly $690 million, Sanofi will develop TroVax for the treatment and prevention of cancers. Oxford BioMedica's lead cancer immunotherapy is currently being studied in a Phase III renal cancer trial called TRIST. The product has been evaluated in more than 180 patients with various forms of cancer, Sanofi said.

Because TroVax targets the tumor antigen 5T4, which is broadly distributed throughout a wide range of solid tumors, it may have applications across a range of tumor types, including lung, breast and prostate. The companies are targeting colorectal cancer and renal cell carcinoma as lead indications for its development, according to Sanofi.

Under the terms of the deal, Sanofi will make a €29 million ($38.6 million) upfront payment to Oxford BioMedica. The company will pay €19 million ($25.3 million) in milestone payments during the TRIST study and will also pay additional milestones based on progress in development and registration. The full value of the deal could reach €518 million ($689.5 million).

Sanofi and Oxford BioMedica will co-fund TRIST, but Sanofi will fund all future research, development, regulatory and commercialization activities, including the immediate implementation of a development plan for the cancer immunotherapeutic in metastatic colorectal cancer.

Although Sanofi will be responsible for the commercialization of TroVax, U.K.-based Oxford BioMedica will retain an option to copromote in the U.S. and European Union.

The timing of the deal comes just as FDA's Cellular, Tissue and Gene Therapies Advisory Committee is preparing to review a therapeutic cancer vaccine for the first time on March 29 (see ¹ related story). The BLA for Provenge for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer has a May 15 user fee date (² Also see "Dendreon's Provenge Therapeutic Cancer Vaccine Has A May 15 PDUFA Date" - Pink Sheet, 16 January, 2007..

Other drug makers are also working to develop therapeutic cancer vaccines, including Antigenics, which is studying Oncophage in Phase III for renal cell carcinoma; Cell Genesys, which is studying GVax in Phase III for prostate cancer; and Intracel, which is evaluating OncoVax to prevent recurrence in stage II colon cancer following surgical tumor resection.

-Jessica Merrill (j.merrill@elsevier.com)

Sanofi Gains Therapeutic Cancer Vaccine TroVax In Deal With Oxford BioMedica

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