Biosyn Inc. could receive up to $10 million through a private grant to develop a fusion inhibitor for HIV.

The International Partnership for Microbicides (IPM) agreed to provide the milestone-driven funding over four years to the Huntingdon Valley, Pa.-based company, which will apply the subsidy to its cyanovirin-N (CV-N) program. The product, which is being developed to prevent the transmission of HIV, was the subject of another $10 million grant awarded last November by the National Institutes of Health in Bethesda, Md.

"[These grants] are a huge validation, providing $20 million of funding for a very novel mechanism of action for preventing the transmission of HIV," Biosyn President and CEO Anne-Marie Corner told BioWorld Today. "IPM is more focused on product development, while the NIH is more focused on the research, so we're getting double validation from two different organizations."

Funding from the latest grant initially will be triggered as Biosyn develops scaled-up production capabilities with low manufacturing costs. Corner added that technical milestones include clearing preclinical research hurdles, such as animal studies and efficacy models, and eventually filing an investigational new drug application to begin clinical studies.

"It's still preclinical, and probably two years from an IND," she said. "Our goal now is to use this funding to really accelerate moving this toward that point."

CV-N, a fusion attachment entry inhibitor, is designed to stop HIV from fusing to cells the virus works to infect. Earlier this year, the FDA approved the first fusion inhibitor for HIV - Fuzeon (enfuvirtide, from Trimeris Inc. and F. Hoffmann-La Roche Ltd.). (See BioWorld Today, March 17, 2003.)

Assuming successful development, Biosyn said it would make its microbicide available to developing nations as part of its arrangement with the IPM, which was launched in the spring of 2002 and has since received contributions from the Rockefeller Foundation, the Bill & Melinda Gates Foundation, the World Bank, the United Nations Population Fund and five European governments.

As for CV-N's potential commercialization, Corner said the 25-employee company eventually would look to partner the product.

"Our goal is to find commercial partners for all the products in our pipeline - strategic partners who can bring marketing muscle to what we do," she explained. "Chop off discovery, we'll take a product all the way through and partner for commercialization. And under our model as a specialty pharma company, we'd like to have our own representatives out there in parallel with our partners."

Founded more than 10 years ago, privately held Biosyn has received venture capital backing and angel funding of $20 million. Other grant funding has defrayed research and development costs as well.

Beyond CV-N, Biosyn's lead candidate is another anti-HIV product that doubles as a contraceptive. Its C31G vaginal gel (1 percent) is in development for contraception and prevention of sexually transmitted diseases including HIV, chlamydia and herpes. The gel, which is entering Phase III trials to evaluate its ability in both roles, is the subject of partnering talks, Corner said. The company has shipped the drug to sites - both in and outside the U.S. - at which the two-year, 6,000-patient program will begin by the end of this year or early next.

"The idea is for a woman to use it as her contraceptive method, and it also takes away the worry about these big STDs," Corner said. "We've gotten tremendous feedback from market research, from both doctors and consumers, for this kind of product."

Other products in Biosyn's pipeline include UC-781, a non-nucleoside reverse transcriptase inhibitor in Phase I trials for the prevention of HIV transmission, and C31G oral rinse (0.5 percent), entering Phase II trials for management of oral infections associated with immune-suppression.

Its preclinical pipeline also includes programs in dermatology and vision.