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

Xconomy Boston — 

Vaccines get the credit for some of the biggest public health gains of the past century, but they are notoriously tough to develop. The required clinical trials take years, cost many millions, and even the slightest safety warning will attract droves of litigators. That’s all for a product that can’t usually command monopoly prices, like, say, a cancer drug.

So why exactly did Cambridge, MA-based Genocea Biosciences raise $23 million in venture capital earlier this year, before it even has a single vaccine candidate showing value in clinical trials? Why would people largely responsible for the two best-selling vaccines ever—Merck’s human papillomavirus vaccine (Gardasil) and Wyeth’s pneumococcal vaccine (Prevnar)—get involved with this startup in its early days? That’s what I delved into with Genocea CEO Staph Bakali when we talked the other day.

There are financial reasons why venture capitalists have suddenly gotten more interested in vaccines like those promised by Genocea, and it isn’t all about impulsive reactions to the latest scary headline on swine flu. Vaccines, which once languished in the pharma industry backwaters, made up a $13 billion market in 2007, according to Lehman Brothers. Sales of vaccines are expected to grow at an 18 percent annual clip through 2011, compared with 4.4 percent projected growth for the drug industry as a whole during that period, according to Lehman. Both Gardasil and Prevnar have proven that vaccines don’t have to be commodities anymore—they can garner high prices and create new billion-dollar markets.

“It’s the fastest growing segment of the pharmaceutical industry,” Bakali says.

Looking through that lens, the work of microbiologist Darren Higgins at Harvard Medical School suddenly appeared to have more than academic interest when the company was started in 2006. Genocea has built its foundation on a technology that’s supposed to mimic the human immune system in a lab dish, which helps researchers identify the most important antigens for inclusion in vaccines, Bakali says. These antigens—substances that spark an immune reaction—are supposed to help the body do more than just stimulate the production of the usual antibodies, or B-cell response, that traditional vaccines are known to provoke.

Staph Bakali

Staph Bakali

Instead, Genocea, with the help of proprietary computer algorithms, is looking for antigens that can stimulate the second major element of the immune system—T-cells—that are widely predicted to be necessary players if researchers hope to develop effective vaccines for major sexually transmitted diseases, or infectious agents like tuberculosis and malaria, Bakali says.

To uncover ways to alert these T-cells, Genocea is drilling deep 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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