VaxInnate, a Cranbury-based start-up, could become the first line of defense against the swine flu. “We’ve been speaking with the CDC and the NIH. We’re already begun working on a vaccine,” says spokesperson Janet Skidmore. “We started working on it more than a week ago. We hope to produce a prototype to test in animals in June, and could have the first doses in 12 weeks.”

VaxInnate’s hallmark is the ability to produce flu vaccine very quickly. The company uses molecular biology to produce vaccines in e. coli instead of eggs or cell culture, which enables it to produce a product in about six weeks.

“Six weeks is very, very fast,” says Skidmore. The traditional timeframe for producing flu vaccine is not only far longer, but it also includes a degree of guesswork. Vaccines are generally incubated in chicken eggs, a process that takes six to nine months. If vaccine manufacturers don’t include flu strains that are predominant in the year for which they are developed, there is no time to make more batches.

“The process does not allow for second chances,” says Skidmore. It also does not allow for protecting the public against a fast-spreading pandemic of a brand new strain of flu. VaxInnate’s bacteria-based method of developing flu vaccine, in contrast, could “produce enough vaccine for everyone in New Jersey in three weeks.” Enough to vaccinate the population of the entire country could be available in “a timeframe of weeks instead of months.”

VaxInnate already has tested a vaccine in clinical trials for Solomon Islands flu, which is an H1 flu like the swine flu.

The company has already gotten good Phase I results from tests of a universal flu vaccine, and, says Skidmore, it is possible that this vaccine could be effective against the new swine flu. A universal vaccine is meant to be given just once a lifetime, rather than each year, and is meant to provide protection from both seasonal and pandemic flu strains. If the swine flu now spreading around the globe is a good match with VaxInnate’s universal flu vaccine, it is possible that that vaccine could be used against the swine flu.

But both the universal vaccine and the vaccine being developed for the swine flu would require FDA approval before being used on humans, Skidmore says. She declines to speculate on whether or not the FDA might fast track approval should the swine flu pandemic worsen.

VaxInnate’s focus is on developing novel, proprietary vaccines for both pandemic and seasonal influenza. The company was founded by Ruslan Medzhitov and Richard Flavell, both of Yale University and Howard Hughes Medical Institute. The company started in 2002 with a research team in New Haven, Connecticut, where it still maintains a laboratory. It later added a 30,000-square-foot corporate headquarters in Cranbury, where it now has approximately 58 employees, most of them involved in research and development. The company’s funders include CHL Medical Partners, and HealthCare Ventures.

In an interview last fall (U.S. 1, October 29), when VaxInnate released news of its universal flu vaccine, Skidmore was proved right sooner than she may have imagined when she said of the probability of a flu pandemic: “It’s not a matter of if, it’s a matter of when.”

VaxInnate, 3 Cedar Brook Drive, Suite 1, Cranbury 08512; 609-860-2260; fax, 609-860-2290. Alan Shaw, CEO. www.vaxinnate.com.

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