Emerging Drug Developer: VaxInnate

 VaxInnate breaks a new path in vaccine development

The global alarm sounding over the outbreak of a new strain of H1N1 has once again highlighted just how inefficient the vaccine industry is.

Using traditional, egg-based vaccine development methods, it can take months to start generating the supplies needed to begin to guard the world's population. And health experts were quick to point out the likely disparity that would swiftly emerge in a competition for stockpiles between the developing world and more affluent industrialized nations--which already have supply contracts with the globe's top manufacturers.

But a small developer in Cranbury, NJ believes it may have the answer to one of the world's most complex challenges.

VaxInnate takes flu virus protein antigens--the basic building block in existing vaccines--and combines them with the bacterial protein flagellin, which interacts with toll-like receptors, heightening the potency of the vaccine. In essence they're the body's policeman and garbage man, explains VaxInnate CEO Alan Shaw, PhD. They pick up pathogens and then chew them up. And by producing the fusion flagellin-antigen in bacteria, they can brew up vast stockpiles in weeks at a significantly reduced cost.

VaxInnate's science originated at the Yale University lab of Charles Janeway, who had concentrated on the role of toll-like receptors, or TLRs. Yale immunologist Richard Flavell helped arrange to spin out the work into VaxInnate, with investors coming together for the first round in 2002.

CHL Medical Partners provided the company's first round, and they brought on board HealthCare Ventures, Oxford Bioscience Partners and MedImmune Ventures in the second round in 2004. A little more than a week ago VaxInnate announced that The Wellcome Trust took the lead on its latest round, $30 million, bringing its total haul to $95 million.

"It should take us for a good couple of years or more," says Shaw, who had worked at the Merck Vaccine Research Division before moving to VaxInnate. "And we're in a position where we'll see some partnership revenue and things like that appear."

Much of the money is being spent on clinical trials for a universal and a seasonal vaccine.

"For the universal vaccine we have a study to show efficacy," says Shaw. "We'll have data at the end of spring next year," he says. A number of studies are being done on a seasonal flu vaccine. "We're looking to go into the elderly next," he says, a group that has the highest risk of death from seasonal flu and the lowest response rate to existing vaccines. 

Says Shaw: "We'll have that data toward the end of the year."

VaxInnate's platform technology can be pointed in a variety of directions, including dengue fever. And other developers have expressed an interest in licensing the technology for targets that VaxInnate doesn't have the time or resources to aim at.

"We're 52 people," explains Shaw. "We have to focus on a few things we can accomplish. We can't do everything all at once."

Swine flu, though, proved too compelling to overlook. VaxInnate launched a special program for the new flu soon after the virus appeared in Mexico.

But while the developer is making progress in its field, the CEO sees a long road ahead before the company can reach an approval for seasonal flu. That's a goal VaxInnate likely won't reach on its own until 2014.

But Shaw isn't discouraged or surprised.

"In 2004, I was on an [Institute of Medicine] panel and they were talking timelines for drugs and vaccines," says Shaw. "The guys at Roche talked timeline for Tamiflu. From start to finish it took 13 years." And that's the same amount of time it took to go from start to approval for Gardasil, a program--which Shaw worked on--that stretched from 1993 to 2006.

Both types of development programs are perilous journeys, he adds, but the "risk and failure points for drugs and vaccines come at different points. The pitfalls in vaccine development are in coming up with the right antigen."

Theoretically, though, a pandemic could change that timeline dramatically.

"The FDA has a guidance on producing pandemic vaccines," says Shaw. "We are working on a swine flu prototype right now. We're on our way. We can have a clean protein to put in animals six weeks from the start of the exercise. And then we'll see what goes on and decide what to do next. The point is you can turn these around quickly."

VaxInnate believes that it can use its approach to produce two billion doses over a very short period. E coli doubles quickly, says the CEO. The flagellin technology makes it potent. And the production can be done by existing contractors. You don't need to build a special facility to start supplying vaccine.

If they can make their case, VaxInnate might overtake the cell-based approach to vaccine production before it becomes established as the primary successor to egg-based work.

"I wouldn't be surprised," says Shaw. "If you look at the economics of cell-based production, it doesn't really make commercial sense to a lot of people."

Emerging Drug Developer: VaxInnate
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