The U.S. Department of Health and Human Services (HHS) apparently likes what it's seen from a 5-year contract with VaxInnate. Its Biomedical Advanced Research and Development Authority (BARDA) has extended the contract's base period with the flu vaccine maker, a move that allows for the use of $53 million.
|VaxInnate CEO Wayne Pisano|
The New Jersey biotech will put the extra time and funding toward trials of its two flu vaccine candidates. For the further-along of the pair, a seasonal flu prospect, the plan is to initiate a Phase II study in healthy adults aged 18 to 64 by midyear, CEO Wayne Pisano told FierceVaccines.
The company is looking to bring the other prospect, a pandemic flu vaccine, into two separate studies, the first of which will combine the jab with an adjuvant in hopes of boosting immune response. A Phase II study will follow immediately, Pisano said, and he expects that to start by year's end.
"We are committed to identifying, wherever possible, nondilutive financing to drive our development programs forward," he said in a statement. "We appreciate the continued support of BARDA and look forward to advancing our seasonal and pandemic influenza programs."
For BARDA, VaxInnate's draw is its manufacturing speed. Unlike traditional egg-based vaccine production, which takes about 5 to 6 months, VaxInnate can produce bulk lots in 9 to 12 weeks using its recombinant protein technology--speed Pisano called "unsurpassable" by any other tech that's currently out there.
"It's the reason BARDA is funding VaxInnate," he told FierceVaccines. "They're concerned about pandemic, and 'how fast can you produce vaccine.'"
But swift manufacturing isn't just a valuable trait in a pandemic shot. Right now, thanks to the lengthy production process, health authorities are forced to make their recommendations for which strains to include in seasonal flu vaccines months before flu season hits--and if officials predict incorrectly, as they did this year, there's nothing vaccine makers can do about it.
In theory, VaxInnate will be able to solve that problem once it brings its jab to market. "We could have created a monovalent H3N2 that matched the strain that's circulating, and that vaccine could have been delivered in the October-November timeframe. It could have been used to immunize people at the greatest risk--like a booster shot for the seasonal vaccine," Pisano said. "We have the ability to go back in at a very late point in the season and still get a dose out."
With this season's vaccines registering a 23% effectiveness rate, researchers are on the lookout for other alternatives to the egg-based method. Right now, Novartis ($NVS) and Protein Sciences market cell-culture vaccines that take just weeks to produce, but those flu blockers currently hold only a small corner of the market.
- read VaxInnate's release