Rockville Firm's Malaria Vaccine Moves to Trials

UPDATED, 3:40 P.M., with comments from Dr. Anthony Fauci of the National Institutes of Health.

A Washington area biotech said today that it won approval to test its malaria vaccine in healthy adults.

The vaccine, by Rockville-based Sanaria, is different than most, being made with a live, but weakened, malaria parasite. The unscientific version of how it works goes like this: Take infected mosquitoes and extract the malaria parasite from them. Then irradiate that so it's not as strong, and use that as a basis for a vaccine. This is how many vaccines, like polio, work. But most malaria vaccines are made from a smaller unit of the parasite and involve gene splicing.

"For many years, the malaria field has known that the best way to protect against malaria was immunizing by the bite of these infected mosquitoes," said Stephen L. Hoffman, chief executive of Sanaria. "But everyone in the field thought it was impossible to manufacture them, and even more impossible to get the FDA to approve it."

Hoffman is a specialist in tropical infectious diseases who has worked for the Naval Medical Research Center and Celera, which was founded to sequence the human genome. He started Sanaria out of his kitchen and applied for grants to come up with a malaria vaccine. He's gotten them, to the tune of about $60 million, including some that come from PATH Malaria Vaccine Initiative, funded by the Bill and Melinda Gates Foundation.

Kirsten Lyke, a malaria specialist at the University of Maryland School of Medicine, is running trials of the vaccine. The trials, at the university and at the Naval Medical Research Center, are also funded by the MVI, but independently of Sanaria. The tests are combining phases 1 and 2 of typical tests, meaning they're testing for both safety and efficacy. The next step would be field tests in Africa with a lot more people involved.

Lyke sees Sanaria's vaccine as a potential breakthrough for malaria.

"We're shooting for 100 percent protection, and there's nothing out there that approaches that," Lyke said.

One strain of malaria causes 99 percent of deaths, many of whom are children in Africa. But the disease also affects U.S. military operating in tropical and subtropical areas, U.S. and European travelers to those areas and the upper and middle classes in affected countries, which Hoffman sees as the vaccine's market.

For now, the company is relying on funding from nonprofits, though Hoffman said that he thought by this point Sanaria would be looking for equity funding.

"The timing is not great. The kind of money that we need and just what the market has done to the valuation of any company is not in our favor," he said. "So we're looking in other arenas still and hope to be able to keep carrying on until the investment situation gets better and money doesn't cost so much."

So they plan to move toward with the first tests of their vaccine. Hoffman declined to predict how long it would take to bring a vaccine to market, but he said he expects it to be faster than the 10 to 15 years (and cheaper than the $1 billion to $1.5 billion) vaccines generally take from this point.

"We feel that given how fast we've gotten to where we are that we can do that for a lot less money in a lot faster time," he said. He cautioned, though, that there's a lot the company doesn't know: how big the doses should be, how far apart should they be administered, and where on the body injections should be given.

Just getting to the tests, though, is significant, said Anthony Fauci, director of the National Institutes of Health's National Institute of Allergy and Infectious Diseases. People doubted that a live, attenuated vaccine could be made and that the FDA would approve it for tests. The NIH has give money to Sanaria, as well as other makers of malaria vaccines. Fauci said he has learned better than to use the word breakthrough, but, he said, "I do think I would characterize it as an important step, an important step for this product."

By Terri Rupar  |  April 23, 2009; 12:17 PM ET  | Category:  Biotech
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