Lysing what it sees

Amgen buying BioVex for OncoVEX immunotherapy based on Phase II melanoma data

Since the approval of Dendreon Corp.'s Provenge finally validated the idea of cancer immunotherapy, one of the next big questions has been how this treatment modality would be incorporated into the portfolios of major oncology players. Amgen Inc. provided an idea last week, committing $425 million in cash up front and up to $575 million in milestones to acquire BioVex Inc. for its OncoVEX GM-CSF, an oncolytic vaccine to treat advanced melanoma and head and neck cancer.

The key message is that buyers and investors can now look beyond questions about the science behind immunotherapies and instead focus on what happens in the clinic.

OncoVEX is a genetically modified herpes virus type 1 (HSV-1) designed to kill tumor cells at the site of injection while simultaneously recruiting the patient's immune system to attack tumors elsewhere in the body. The product has the potential to be used off the shelf, avoiding many of the logistical and manufacturing complexities associated with an autologous product like Provenge.

The science behind an oncolytic virus to treat human disease is elegant but the clinical results have been largely discouraging, according to Amgen's EVP of R&D Roger Perlmutter.

Doubts about the approach may explain why results from a Phase II trial of OncoVEX in metastatic melanoma made few waves when they were announced in 2008, even though they appeared to match up well against high-profile agents such as ipilimumab (MDX-010), a human mAb against CTLA-4 (CD152) from Bristol-Myers Squibb Co.

While the OncoVEX data were from an uncontrolled study in only 50 patients, Amgen found the results sufficiently compelling that it decided not to wait for results from a pair of ongoing Phase III trials. Instead, Amgen became

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