BioVex, a cancer drug developer based in Woburn, MA, reported some impressive clinical trial results that we covered last June. Now the company has raised $40 million in venture capital to see if it’s good enough to bring this drug candidate to the marketplace.
The investment round was led by Amsterdam-based Forbion Capital Partners, which was joined by existing investors that include Credit Agricole Private Equity, Innoven Partners, New Science Ventures, Triathlon Medical Venture Partners, and Scottish Equity Partners.
This group of investors are wagering on a concept that has intrigued cancer researchers for years—oncolytic viruses. These are 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 of these viruses and attaches it to copies of GM-CSF, an immune-boosting drug. The combination is supposed to help the immune system hunt down all sorts of cancer cells that have spread throughout the body.
Results from a study of 50 patients with metastatic melanoma—a deadly form of skin cancer that has metastasized widely in the body—showed that this technique was able to completely wipe out tumors for eight patients, and partially shrink tumors for another five patients. Eleven of the people who responded to therapy remained stable for more than six months, the company said. Side effects of the drug were consistent with other treatments of its kind-mild fever, chills, and fatigue, said Neil Senzer of Mary Crowley Cancer Research Center in Dallas, in an interview last June. Researchers saw no evidence that the treatment created a dangerous overreaction of the immune system, he said.
BioVex CEO Philip Astley-Sparke said the trial produced an “unprecedented number of durable complete remissions,” and sparked interest in doing the pivotal trial.
The new $40 million round of cash—the sixth round of financing in the company’s history—will be used to pay for the kind of trial the FDA needs to see before it would approve such a drug for the market. It is expected to enroll 360 patients, comparing those on the drug to people who get a placebo. The goal will be to show tumor shrinkage—not the more time-consuming and difficult measurement of survival time—so BioVex says it expects to produce results as soon as 2010. The $40 million is supposed to be enough to take the company through the clinical trial and complete an application to the FDA, although BioVex is planning to raise another $20 million later this year, the company said.
BioVex, founded in 2000, is built on research by Robert Coffin at University College London. It uses the herpes simplex virus, the one that causes cold sores. The technology is designed to work by deleting a gene that the virus needs to infect healthy tissues, while leaving machinery intact that lets it replicate inside tumors. Once it 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 against cancer. BioVex says its treatment is further along in clinical trials.
