BioVex, the Woburn, MA-based company aspiring to create the first FDA-approved cancer-killing virus, has raised an additional $30 million in private financing to finish off a pivotal clinical trial needed to prove the virus is good enough to reach the U.S. market.
This latest round brings BioVex’s grand total of financing this year to $70 million; the firm nailed down $40 million in March. Participants in the new round include Morningside Venture, Ventech, MVM Life Science Partners, Sectoral Asset Management, and Ysios Capital Partners.
This batch of investors is betting on an idea that has fascinated cancer researchers for decades—oncolytic viruses. These are everyday viruses that are genetically modified to replicate inside tumors, provoking the immune system to mount an attack in the cancerous growth itself, while sparing healthy tissue. The BioVex treatment, OncoVex GM-CSF, takes one such virus and attaches it to GM-CSF, an immune-boosting drug. The combination is supposed to work by penetrating tumor cells and causing them to burst from the inside, while also sparking the immune system to hunt down any cancer cells that have spread throughout the body.
“If this is approved, it will be paradigm-changing,” says Philip Astley-Sparke, BioVex’s CEO.
BioVex has attracted the interest of researchers, and the investment capital, 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. More interesting, eight of the 13 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 Astley-Sparke, more than half of 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. Side effects were mostly mild-to-moderate flu-like symptoms, researchers said.
“What’s really most impressive is the durability of the response,” Astley-Sparke says.
Those who follow cancer drug development know that melanoma is very tough to treat and has long been a graveyard for once-promising biotech drugs. So BioVex has to prove the earlier study wasn’t a fluke, in an ongoing study that’s 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 month or more, compared to an immune-boosting compound.
Running a trial that big costs money, and the new $30 million is needed to enable BioVex to finish the trial, with a goal of filing for FDA approval in mid-2011, Astley-Sparke says. If that happens on time, the company could win clearance to start marketing OncoVex as soon as the end of 2011, he says.
BioVex, which has about 50 employees in Woburn and 25 more in the U.K., is built on research by Robert Coffin at University College London. Its treatment is based on the herpes simplex virus, the one that causes cold sores. BioVex deleted a gene that the virus needs to infect healthy tissues, while leaving intact the machinery that lets the virus replicate inside tumors. Once the engineered virus gets inside a tumor, it’s supposed to cause the tumor to burst.
At least two other companies, Germany-based MediGene and Calgary, Canada-based Oncolytics Biotech, are also pursuing oncolytic virus treatments for cancer. BioVex says its treatment is further along in clinical trials and is poised to be the first to reach the marketplace.
The oncolytic virus model doesn’t need to be personalized to individual patients, so it can avoid some of the manufacturing hassles that are common with cancer immunotherapies like Seattle-based Dendreon’s sipuleucel-T (Provenge), Astley-Sparke says. The BioVex treatment also can be applied to multiple tumor types—the company says it has encouraging data for its treatment against four malignancies, and has agreed with the FDA on the design of another pivotal trial of OncoVex for patients with head and neck cancer.