BioVex readies cancer therapy for Phase III
Bolstered by a fresh, $40 million injection of venture capital, Woburn, MA-based BioVex is preparing to put its cancer-destroying virus technology to the ultimate test.
"We're going to start Phase III in a few weeks time, by the end of this month," says CEO Philip Astley-Sparke. "The 40 (million dollars) gets us to the middle of next year. It will allow us to get to interim Phase III data, which is highly predictive of the ultimate outcome." And Astley-Sparke is hot on the trail of another $20 million that will fund the company's preparations for a BLA filing.
BioVex got started in the lab of University College London scientist Robert Coffin, who did the original research into oncolytic virus therapies. The developer was founded in the UK in 2000 and moved to Boston about four years ago. Now, two thirds of its 66 staffers work in the U.S.
It made good sense to become a U.S.-based biotech, says Astley-Sparke. The company needed to build a launch-grade manufacturing facility and there were simply more deep-pocket investors on this side of the Atlantic. Astley-Sparke says he may well name a few of them when the company announces the next tranche of its fifth round.
"It's just a better place to be," says the CEO. "The U.S. sector may be struggling, but the U.K. sector is even worse."
And finally, he adds, the key test for any big product is an FDA approval. "If we are ever going to launch this product," he adds, "obviously the U.S. is the largest market."
BioVex's business plan was never dependent on a partnership, says the CEO. And even now, on the verge of Phase III, Astley-Sparke is clearly wary about signing on with a partner. The CEO says he's in talks with potential partners now, but if he has to go it alone through Phase III, the company will have the money on hand to finish the study. Any deal he does will be on BioVex's terms, he says emphatically. Nothing will be dictated.
"We can make sure that if we do a partnership deal, we can do it on the best terms. It's perfectly feasible with this technology to market it alone," he adds. "I'm not saying we would prefer to do it alone. We wouldn't prefer to do it. But the company can weigh its options and review term sheets by the end of this year."
BioVex's list of investors still includes a mix of European venture groups. Amsterdam-based Forbion Capital Partners joined with Credit Agricole Private Equity, Harris & Harris Group, Innoven Partners, New Science Ventures, Triathlon Medical Venture Partners and Scottish Equity Partners in the latest round. And while it's obviously getting harder to raise funds, Astley-Sparke doesn't sound at all daunted by the experience.
"It's an ongoing experience," says Astley-Sparke. "I would say that there are still people with money out there. It's more challenging than at any time in 10 years, but with the right profile and expectations on valuations, it is possible to raise money. I'm pretty optimistic we will close out the round."
Investors' interest is focused most intently on BioVex's lead program for OncoVEX GM-CSF, a cancer-destroying virus--modified from a cold sore virus--that has dual mechanisms of action. It's designed to replicate in solid tumors, triggering cancer cell death, while spurring the immune system to go in and tackle the cancer as well. Phase III will test the therapy on patients whose skin cancer has spread to other organs,
"We saw a 26 percent response rate in Phase II," says Astley-Sparke, "which is very high in comparison to the state of the art. What is particularly impressive is the durability of the responses." In other programs, the response rate is transient. At BioVex, 12 out of 13 responses lasted at least six months. Some of the patients have been in remission for three years."
The primary goal in late-stage testing will be a statistically significant increase in "durable objective response," says the CEO, "reducing disease burden by at least 50 percent over 6 months."
"In essence, if we see a third of what we saw in Phase II we'll be set for an approval."
In the meantime, BioVex's second program-a prophylactic vaccine for genital herpes called ImmunoVEX HSV2--is slated for a Phase I trial in the UK. But unlike the cancer program, Astley-Sparke is intent on finding a partner early on for its genital herpes program. Mid- to late-stage vaccine testing in this field requires thousands of patients, he adds, and that will take more money than he has available.
Past this current round, BioVex could take a number of different routes. And unlike many of his colleagues in biotech, Astley-Sparke is not ruling out an IPO in the not too distant future.
"I don't think the market would have to turn around dramatically for a company that has a product approved and underway" to get an IPO through, he says.