Genocea, Attracting Merck and Wyeth Vaccine Gurus, Pushes New Immunizations to Clinic

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into immunology. It is analyzing biological samples from people who have been exposed to a pathogen but somehow remain naturally protected from the virus. Then it compares their immune system profiles to people who were exposed, then suffered from infection, to look for differences, Bakali says.

“This way we can get an understanding in man, very quickly and in an unbiased way,” Bakali says.

Under the traditional methods for vaccine discovery, researchers would pick out antigens that seemed likely to stimulate an immune reaction, run them through animal tests, and settle on the best candidates through trial-and-error. Many candidates failed, so it would usually take about 10 years to pick the best one, he says. “What Genocea is doing is accelerating that process from about a decade to as little as a few months,” he says.

OK, so where’s the proof? Genocea, which got the license to its technology from Harvard in March 2007, has settled on a lead vaccine candidate—against a still-undisclosed disease—which it intends to take into clinical trials as soon as the end of 2010, Bakali says. It has two more vaccine candidates in its pipeline, for Chlamydia and streptococcus pneumonia, which are a little further behind in development, Bakali says. “To go in under three years from the lab to the clinic is very impressive,” he says.

Still, these are early days for the company, and Genocea isn’t saying a whole lot about the data it’s getting on the effectiveness of its candidates. The company has identified novel antigens, formulated them into vaccine candidates, inoculated two different species of animals, and found they were protected after being directly exposed to infectious agents, Bakali says.

So far, the work is intriguing enough that it has drawn interest from a couple of prominent names in the vaccine business. George Siber, the former chief scientific officer of Wyeth Vaccines and the man who oversaw the development of Prevnar, is the company’s executive chairman. Adel Mahmoud, who was president of Merck Vaccines during the Gardasil development years (when Merck also undertook less-successful efforts with an HIV vaccine), is a scientific advisor to Genocea.

Bakali is himself a veteran of the vaccine business, most recently as chief operating officer of Vancouver, BC-based ID Biomedical, which was sold to GlaxoSmithKline in 2005 for $1.4 billion. There, he was part of a management team that focused on flu vaccines, and the company had the good fortune to acquire one of the few commercial flu vaccine factories in North America right before a contamination problem at Chiron caused a global shortage of the product. So he knows strategy is important, but so is timing.

This time, he sees major drugmakers like AstraZeneca building up an interest in vaccines, largely through its 2007 acquisition of MedImmune. Pfizer, another company that hasn’t done much in vaccines, is becoming a big player in the field through its pending takeover of Wyeth, Bakali also notes. For a 23-employee startup like Genocea, with some potentially valuable technology for discovering vaccines, the future will depend on whether Big Pharma companies remain interested enough to form partnerships.

Some of this, Bakali freely acknowledged, is beyond any one person’s control. The way he looks at it, a company needs a special technology, a great team, strong investors, and the ability to stay focused on a goal. Then, there are the outside forces that can’t be controlled, like whether vaccines remain hot five years from now. “The last thing you need,” Bakali says, “is good luck.”

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