Four years after near-death experience, PhIII data bring good news for Novavax
Novavax is celebrating trial results again four years after a Phase III failure in RSV sent their stock price off a cliff.
The company announced that their recombinant flu vaccine NanoFlu met all primary and secondary endpoints in a Phase III study of 2,652 adults older than 65. The numbers, Novavax suggested, should allow them to clear regulatory hurdles and snag the biotech’s first approval since its founding in 1987.
“With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” CEO Stanley Erck said in a statement. “We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.”
The study was a non-inferiority trial testing NanoFlu head-to-head with Sanofi’s best-selling Fluzone. The company, though, did not release the statistics for the primary endpoints. Instead, they released the secondary endpoints, which tests in part how the vaccine performs against a wild-type virus that has drifted from the previous year, arguing that those numbers better reflect the real world. They showed NanoFlu induced patients to build more antibodies against the wild-type virus than Fluzone.
The company said the safety profiles were similar but acknowledged NanoFlu brought “a modest increase in local adverse events.”
The readout comes nearly four years after an RSV readout popped the industry’s expectations for Novavax and its nanoparticle vaccine platform. The biotech had received an $89 million grant from the Bill and Melinda Gates Foundation to develop the vaccine for respiratory syncytial virus, which remains a leading hospitalizer for babies in Europe and other parts of the globe and is a frequent target for vaccine makers. Moderna, CureVac and Sanofi each have programs.
That trial didn’t meet any primary or secondary endpoints and triggered an 84% one-day drop in the stock price, from $155 per share to $24. The stock fell again after another RSV failure last February. Once at $2 billion, its market cap hovers around $550 million.
The flu is the main program outside of RSV, although the company has recently received outside backing for an emergency coronavirus vaccine effort.
Social image: Stanley Erck (Cindy Bertaut, Glogau Photography)