Amgen is sticking its scientific neck out, and potentially $1 billion of its cash, to buy a company in Woburn, MA that hopes to deliver the first FDA-approved virus engineered to specifically kill cancer cells.
Thousand Oaks, CA-based Amgen (NASDAQ: AMGN) said today it has agreed to pay $425 million upfront, plus another $575 million in additional development and sales milestones, to obtain privately-held BioVex. Amgen, which has significant research and development operations in South San Francisco, Seattle, and Cambridge, MA, said it expects to close this deal before the end of March.
BioVex, which we last wrote about in November 2009, raised $70 million in venture capital that year to carry out the final steps of development with its oncolytic virus therapy. BioVex is seeking to harness decades of science, in which researchers have sought to genetically modify viruses to replicate inside tumors, while sparing healthy tissue. Once inside, the treatment (OncoVex GM-CSF) is supposed to cause tumor cells to burst. But it doesn’t stop there—it is also designed to provoke the immune system to mount an attack in the cancerous growth itself, and hunt down any cancer cells that have spread throughout the body.
BioVex, as I noted in these pages just over a year ago, has attracted interest from scientists and investors based largely on one study of 50 patients with forms of melanoma, a deadly skin cancer, that have spread through the body. That study found that 13 of the 50 patients (26 percent) had their tumors shrink after they got the BioVex treatment.
Even more interesting, eight of the 13 initial responders had their tumors completely disappear, and their responses were long-lasting. Although patients who entered the trial had terminal diagnoses, usually giving them six to nine months to live, according to BioVex CEO Philip Astley-Sparke, more than half of the patients were alive after one year (58 percent) and two years (52 percent), according to data presented at the American Society of Clinical Oncology in June 2009. Side effects were mostly mild-to-moderate flu-like symptoms, researchers said.
The company is now in the midst of gathering more proof from a Phase III clinical trial which, if successful, could be the basis for it to win FDA approval of the first such oncolytic virus therapy. BioVex is running a trial expected to enroll as many as 430 patients, according to a posting on clinicaltrials.gov. The goal will be to show the BioVex drug offers an advantage in tumor shrinkage that lasts six months or more, compared to an immune-boosting compound.
“OncoVex has demonstrated encouraging anti-tumor activity in clinical studies for the treatment of melanoma and head and neck cancer, and BioVex is currently enrolling patients into pivotal Phase 3 trials in both indications,” said Roger Perlmutter, Amgen’s executive vice president of R&D, in a statement. “Amgen is particularly excited about joining with BioVex and its talented staff to focus on advancing this late-stage investigational therapy, with the hope of bringing it to market within the next few years.”
No one has ever developed such an oncolytic virus treatment for cancer, although many, such as South San Francisco-based Cell Genesys, have tried before. While BioVex may have the candidate most advanced in clinical trials at the moment, it’s not the only company generating new interest in the field. San Francisco-based Jennerex Biotherapeutics, led by a veteran of the early days at Emeryville, CA-based Onyx Pharmaceuticals, is also hot on the trail. So is Calgary, Canada-based Oncolytics Biotech.
Amgen has been pushing for years to become a bigger player in anti-tumor drug development, after making its fortune largely on treating some of the side effects of cancer chemotherapy. It won FDA approval in 2006 for panitumumab (Vectibix), and saw limited success. Last year, it followed that up with an FDA clearance of denosumab (Xgeva) as a treatment for bone-related tumors. We’ll find out soon enough whether this new bet on oncolytic viral therapy puts Amgen on the leading edge of a new field of science, or ends up being a costly debacle.
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