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Genocea Eyes Vaccines that Treat, Not Just Prevent, Infectious Diseases

Genocea Biosciences sees a big potential in high-speed technology for discovering vaccines—not only ones that prevent diseases, but also ones that treat them. Indeed, the Cambridge, MA-based biotech has decided to pursue an immune-boosting therapy for genital herpes as its lead product candidate.

Genocea (pronounced Jen-O-shuh) has been one of the biotech startups to watch in town since it raised $23 million in its Series A venture round in February; I profiled the company and its CEO Staph Bakali back in August. The startup’s technology is designed to mimic the human immune system in a lab dish, which helps researchers establish a high-speed process for identifying the best antigens to include in vaccines, Bakali says. These antigens-substances that spark an immune reaction-are supposed to help the body mount a T-cell based immune response in addition to the more traditional antibody response that traditional vaccines are known to provoke.

Vaccines that prevent disease, like flu, are notoriously difficult to develop because of the huge numbers of patients that typically need to enroll in long, expensive clinical trials. While Genocea still sees preventive vaccines as a core part of its strategy, it has picked a therapeutic vaccine for herpes simplex virus 2 (HSV2) as its lead candidate because it can generate evidence that it works in smaller clinical trials, potentially offering a faster path to the marketplace, Bakali says. An estimated 45 million people in the U.S. ages 12 and older have the infection, which causes blisters in the genital area. The market for antiviral medicines is already worth about $2 billion, Bakali says.

“It’s a large market, we think we can do better with a vaccine approach, and there’s a high unmet need,” Bakali says. “We also think we can retain more of the value ourselves until it’s time to find a partner. We’re very excited.” He adds that an initial, Phase I clinical trial of its therapeutic vaccine candidate is short enough that it’s “doable” for a little company like Genocea, which has 25 employees.

Genocea envisions starting a clinical trial of the herpes treatment by the end of 2010, Bakali says. He didn’t go into great detail about how much evidence Genocea has to support this product candidate, although he did say it has passed tests in mice, as well as guinea pigs, which are considered the most predictive animal model for success in clinical trials of herpes treatments.

Genocea is also moving ahead through animal tests with other more classic vaccine approaches for another sexually transmitted disease, chlamydia, as well as for pneumococcal infections in children, which can cause pneumonia, meningitis, ear infections, and other ailments. The pneumococcal program has made progress since it was financed by PATH, the global health nonprofit, to discover new antigens that might help provide broader protection against different strains of the bacterium than Pfizer’s pneumococcal vaccine (Prevnar) provides.

Meanwhile, Genocea’s ability to discover new antigens, and quickly test their ability to protect animals from infection, is drawing the attention of other potential partners, Bakali says.

“We have a lot of interest. We’ve been in discussions with a lot of partners for various programs,” Bakali says.