Vaxart's Tablet Flu Vaccine Succeeds In Phase 1 Clinical Trial

San Francisco-based biotech Vaxart has announced results from a Phase 1 clinical study of its tablet vaccine candidate for H1N1 seasonal influenza demonstrating that the tablet form was just as effective at providing protective immunity when compared to currently licensed flu injections. The promising data was presented by Vaxart at the 15th Annual World Vaccine Congress in Brussels last week.

"A tablet vaccine for flu could significantly change the way we administer vaccines," said John J. Treanor, MD, Chief of Infectious Diseases at the University of Rochester Medical Center.

"Every year, more than 100 million Americans visit their pharmacy, clinic, or private practitioner to receive a flu shot. In contrast, a tablet vaccine could be brought directly to the user, such as in the workplace or at school, and avoids the need to worry about needles. A tablet vaccine might also be manufactured and distributed faster than current injectable vaccines, a factor that could be critical when responding to a pandemic or outbreak. These results look very promising and I am eager to hear more about the continued progress of Vaxart's programs."

The Phase 1 clinical study of Vaxart's H1N1 tablet vaccine was a randomized, double-blind, placebo-controlled study with 24 healthy volunteers who received either placebo or a single vaccine in tablet form. The protective immunity provided by the vaccine was determined using the established standard, hemagglutinin inhibition assay (HAI).

The results showed that:

• There was complete seroconversion, as measured by HAI, in 75 percent of the subjects with the tablet vaccine, with a response rate equivalent to that generated by injectable vaccines.
• In examining Microneutralization (MN) titers, researchers discovered four-fold increases in neutralizing antibody titers in 92 percent of subjects taking the tablet vaccine, which exceeds that observed with currently licensed influenza vaccines.
• In 92 percent of those taking the tablet vaccine, there were strong mucosal and cellular immune responses, thus offering broader protection than other influenza vaccines.
• The vaccine showed an excellent clinical safety profile

Based on the promising results, the company expects that this platform technology could be used to create vaccines for a wide variety of indications. Indeed, Vaxart plans to use the technology to explore its potential in the company’s non-flu programs and hopes to enter the clinic with at least two new indications in 2015.

Vaxart CEO, Wouter Latour, MD said, "We are seeing a safety-immunogenicity profile that could compete with that of any of the currently marketed vaccines, even without taking into account the convenience and logistical advantages of our room-temperature stable and user-friendly tablet. In addition, our tablet vaccine could significantly increase vaccination rates, currently at about 45 percent of the U.S. population."