Biopharmaceutical companies, sooner or later, must get drug candidates moving through clinical trials where most of the value gets created for investors. VLST has spent eight long years working to get to that point, and now it has its first product ready to roll in tests of human beings.
The Seattle-based biotech company is announcing today it has obtained a license from New York-based Pfizer (NYSE: PFE) to an antibody drug for cancer. The product candidate has already completed five Phase I clinical trials that established the drug’s safety profile and maximum tolerable dose, says VLST CEO Marty Simonetti. As part of the deal, Pfizer will retain co-exclusive rights to the product in the oncology vaccine field.
The drug candidate, dubbed CP-870,893, is designed to bind with and stimulate a molecular target called CD40, which VLST hopes will help the body amplify an immune reaction against tumors. As part of this licensing deal, Pfizer is taking a 5 percent equity ownership stake in VLST, and the smaller company will be responsible for advancing the drug into Phase II clinical trials, Simonetti says.
Besides this latest addition to the VLST pipeline, the company has an internal drug candidate called AntiKine in late-stage preclinical testing for autoimmune conditions.
“We started the company as an idea, and from an evolutionary perspective, the company has been working on becoming a clinical stage company,” Simonetti says. “This leapfrogs us into that category.”
Pfizer, as has been well-documented, has been shedding all sorts of new drug candidates from its pipeline as it doesn’t have the financial or human resources to develop every program it obtained in the 2009 mega-merger with Wyeth. The CD40-directed antibody program ended up catching the eye of VLST’s chief scientist, Teresa Foy, because she did some of her postdoctoral work at Dartmouth Medical School on the CD40 target and its relationship to immune responses.
VLST is working on a clinical development plan, which will spell out the detailed next steps for this product, Simonetti says. Although results from the early clinical trials suggest the drug probably won’t work against cancer on its own, it does appear more promising when used in combination with a chemo agent like gemcitabine, Simonetti says. It’s also possible that it could be given in combination with another genetically engineered antibody drug, such as Bristol-Myers Squibb’s ipilimumab (Yervoy).
VLST raised $5 million in June from ARCH Venture Partners, OVP Venture Partners, WRF Capital and Versant Ventures, and has pulled in about $50 million total since its founding in 2004. The company is looking at options to get more money to push the new drug through clinical trials, which include the possibility of another equity financing, Simonetti says. It will also soon be looking to hire some more staff with expertise in clinical development, he says.
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