Vaxart, Inc., a San Francisco biotechnology company developing oral-delivery vaccines, has begun dosing volunteers in a phase I clinical trial. This is the first clinical study evaluating a vaccine that uses the company's novel oral-vaccine platform technology. The trial site is in the United States.

"This first trial in humans is important, because if safety is demonstrated with one vaccine, we can expect that later vaccines using the same Vaxart technology will also be safe," said Vaxart founder and CSO Sean Tucker, Ph.D.

Vaxart's first oral vaccine candidate is designed to protect against H5N1 Avian Influenza. The company also has a pipeline of additional vaccines in development, all based on its oral-delivery technology.

Vaxart also announced the issuance of US patent no. 7,879,602, which provides broad protection for the company's oral-delivery technology. "This patent greatly increases the value of our portfolio because it covers all methods we know of for oral vaccination with a re-usable platform technology," said Vaxart CEO Michael Finney, Ph.D.

Vaxart leverages proprietary vaccine development and formulation approaches to quickly and efficiently produce oral delivery vaccines. Central to the company's approach is the incorporation of a unique adjuvant, the vaccine component that enhances immune responses, in the vector that delivers the vaccine antigen. Vaxart's adjuvant works by binding to Toll-Like Receptor 3 to stimulate a potent immune response when the vaccine is taken orally.

Vaxart's technology also enables all of the company's vaccines to use the same vector, or delivery vehicle. Until now, each time an individual received a vector vaccine, a new vector needed to be used. This is because after receiving a vector vaccine, people develop antibodies to the vector itself, and these anti-vector antibodies reduce the effectiveness of later vaccines using the same vector. Vaxart has overcome this issue and demonstrated robust immune responses against multiple targets following a series of oral vaccines, despite using the same delivery vehicle. Vaxart intends to harness its technology to produce new vaccines through a standardized process, with substantially reduced time lines and regulatory risk due to the common technology foundation.

The H1N1 flu pandemic of 2009 underscored the importance of being prepared for pandemic illnesses. H5N1 Avian flu is endemic in birds in various parts of the world, has repeatedly infected and killed humans, and remains a possible source of an influenza pandemic. Avian flu is an ideal first target for Vaxart's technology. If an outbreak occurs, a precisely-targeted vaccine can be developed and manufactured rapidly, and delivered without the cumbersome and costly logistics necessary for an injected vaccine.

Vaxart is a San Francisco-based clinical-stage biotechnology company developing oral-delivery vaccines. The vaccines incorporate a proprietary adjuvant, which boosts the immune response, enabling a vaccine to be effective when taken orally.