Novavax reports PhII success for quadrivalent seasonal flu vax

Novavax ($NVAX) is making waves in the influenza space, reporting positive Phase II results for its quadrivalent seasonal flu vaccine on Thursday.

The candidate is a recombinant virus-like particle vaccine developed with funds from the U.S. government's Biomedical Advanced Research and Development Authority (BARDA). It was well-tolerated with no vaccine-related adverse events in a trial of 400 adults. The recombinant nature of the vaccine gives it an advantage over traditional flu vaccines, which are egg-based.

Dr. Greg Glenn, Novavax SVP of R&D

What differentiates it is that it reflects the circulating strain exactly, Greg Glenn, Novavax senior vice president of R&D, said in an interview. This could help combat strain drift, as happened this year, when the flu strains that health authorities predicted didn't match the strains that actually circulated.

"If it's known a strain change occurred … because we are recombinant, we can take it into account and manufacture (a vaccine targeting the new strain)," Glenn said. "It needs to be proven, but it is definitely a theoretical advantage."

Another advantage of the recombinant vaccine is the speed at which it can be manufactured.

Novavax CEO Stanley Erck

"We can download the genetic sequence (or the circulating strain) from the Internet and turn it into a protein," Glenn said. With recombinant technology, he added, you can move very quickly from a lethal virus to having a vaccine against it, which is how the company is working on jabs against Ebola, pandemic flu (H7N9) and MERS.

As for next steps, Novavax will review it with its partner, BARDA, and then create a strategy to bring both its seasonal and pandemic flu vaccines toward licensure, Novavax CEO Stan Erck told FierceVaccines.

"The next step for sure will be to go to the next level with the pandemic flu vaccine, … a dose-ranging trial at the beginning of next year," Erck said. In October 2014, Novavax nabbed a fast-track designation from the FDA for its H7N9 candidate.

Competitor VaxInnate is also working on a recombinant quadrivalent seasonal flu jab, which it is testing against Sanofi's ($SNY) Fluzone Quadrivalent in Phase II.

- here's the release