Vaxart's oral RSV candidate protects in preclinical challenge

While working to catch up with other vaccine developers in the race for a respiratory syncytial virus (RSV) vaccine, South San Francisco-based Vaxart unveiled data this week demonstrating its candidate's ability to create a "substantial" immune response in a preclinical challenge model.

The news comes as the privately held company is preparing for a Phase I trial next year. Other companies are further along in the development of their own RSV vaccine candidates, but Vaxart is pursuing a different route than most.

Vaxart's tablet vaccines--Courtesy of Vaxart

In contrast to many vaccine developers, Vaxart is working to develop vaccines that are administered via a tablet rather than an injection, making distribution easier because the tablets are heat stable. Vaxart CEO Wouter Latour said in a statement that the new results, plus previous preclinical results for vaccine candidates against influenza and norovirus, further validate the company's platform.

Vaxart trails other companies in the contest for an RSV vaccine, though. Novavax initiated a Phase III trial earlier this month of its candidate, which was fast-tracked by the FDA last November, and prior to starting the trial received an $89 million grant to support development from the Gates Foundation.

Also racing to develop vaccines against the virus are Bavarian Nordic and AstraZeneca's ($AZN) MedImmune unit. Bavarian Nordic started a Phase I study of its candidate in August, and AstraZeneca--which recently lost patent protection for its blockbuster monoclonal antibody treatment for some RSV cases--earned FDA fast-track status in April for its candidate.

According to CDC figures, RSV, which infects the lungs and breathing passages, leads to 177,000 hospitalizations and 14,000 deaths among adults aged 65 and older in the U.S. each year

Vaxart received $14 million last month from the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) unit to develop its oral flu vaccine candidate. Since its founding in 2004, the company has rounded up financing of $20 million in 2013 and $12.5 million in 2010 to work on its technology.

- here's the release

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