FRIDAY, SEPTEMBER 30, 2016

Vaxart announces Phase I results of tablet influenza vaccine

Vaxart, Inc., a San Francisco-based vaccine development company, announced positive safety and immunogenicity data on Wednesday from Phase I clinical studies with its oral tablet H1N1 seasonal influenza vaccine candidate.

In a placebo controlled, double-blind, randomized, dose-escalation study, Vaxart's oral H1N1 influenza vaccine generated serum anti-hemagglutinin antibody responses and influenza HA-specific T-cell responses in 75 percent to 80 percent of subjects. After the success of the Phase I trial, Vaxart chose to accelerate the development of its oral vaccines for two influenza B strains and for H3N2 influenza.

"This human data along with substantial preclinical data confirms our tablet vaccines elicit protective immune responses and that the Vaxart oral vaccine platform can be used for a wide range of recombinant protein vaccines," Sean Tucker, Vaxart's founder and chief scientific officer, said. "We are now evaluating an optimized version of our oral H1N1 influenza vaccine in a follow-on phase Ib study and look forward to advancing the oral H3N2 and B-strain influenza vaccines into the clinic."

The H1N1 influenza vaccine candidate demonstrated no vaccine-related significant adverse effects. All adverse events were mild and were no more frequent than placebo. There were also no reactogenicity or tolerability issues.

"These studies show that we are closing in on an effective influenza vaccine that is administered using a simple user-friendly tablet," Wouter Latour, Vaxart's CEO, said. "Our vaccine tablets can be kept at room temperature for more than six months greatly simplifying the logistics of annual flu vaccination campaigns. In the event of a pandemic the Vaxart tablet vaccine could even be distributed by mail for self-administration at home. We are eager to make these public health benefits a reality."

Vaxart developed its influenza vaccine tablets through industry standard cell-culture and solid-dose manufacturing processes, which take much less time than egg-based vaccine manufacturing technologies.