BioVex - 2005 Fierce 15 Revisited

BioVex
Based: Cambridge, MA
Founded: 1999
www.biovex.com

Bottom Line: Right on track

What we said: The six-year-old BioVex got started in the U.K., but it clearly sees its future playing out in the United States. Clinical trials involving its new drugs will be based in the U.S., U.S. venture companies will be wooed to take part in its next financing round and the U.S. will likely be the biggest market for its experimental cancer drugs--if BioVex makes it to market approval. That helps explain why BioVex relocated its corporate headquarters from Oxford, England to the U.S. at the beginning of June, just weeks after the FDA cleared the way for a Phase II trial of its lead candidate--the cancer vaccine OncoVex GM-CSF, an oncolytic virus for selectively killing tumor deposits--for malignant melanoma. OncoVex is designed for dual action, killing tumor cells and excreting GM-CSF, an immune stimulating protein. BioVex plans to research OncoVex both as a vaccine and for local control--such as reducing pancreatic tumors so that they are small enough to operate on. Phase I/II clinical testing of ImmunoVEX in malignant melanoma is underway. So far, BioVex has attracted about $60 million in venture capital, with all but one of the investors based outside the United States.

What happened: At the end of March of this year BioVex announced that it had raised $40 million in the first close of its Series F. Two weeks later it started its Phase III clinical trial of OncoVex for metastatic melanoma. And in Phase III "if we see a third of what we saw in Phase II we'll be set for an approval," CEO Philip Astley-Sparke told FierceBiotech recently. Just a few weeks ago the developer announced that it had reached agreement with the FDA on a second Phase III trial that will explore OncoVex's ability to fight head and neck cancer.