Oral vaccine generates robust immune response, including Palivizumab-like antibodies, and provides protection against RSV infection in cotton rat challenge model
Company on track to initiate RSV tablet vaccine Phase 1 study in 2016
November 19, 2015 08:00 AM Eastern Standard Time
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Vaxart, Inc., a privately held, clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced positive results demonstrating that the company's oral respiratory syncytial virus (RSV) vaccine candidate generated substantial immune responses and protection against infection in a preclinical RSV challenge model. The data were presented at RSV Vaccines for the World (RSVVW) 2015 in La Jolla, Calif.
"Oral immunization with the Vaxart RSV vaccine generated anti-F systemic antibodies and induced substantial protection against RSV infection in the cotton rat challenge model, the industry-standard animal model for RSV," said Sean Tucker, Ph.D., chief scientific officer at Vaxart. "The study further demonstrated that the vaccine produced RSV neutralizing antibodies, as well as antibodies that compete for binding of Palivizumab to the F protein. This study provides meaningful preclinical validation as we move towards the initiation of our Phase 1 clinical study in 2016."
RSV is a respiratory virus that infects the lungs and breathing passages. It is a significant cause of respiratory illness in adults with compromised immune systems and those 65 and older. According to the Centers for Disease Control and Prevention (CDC), RSV causes 177,000 hospitalization and 14,000 deaths among adults older than 65 in the United States each year. Currently, there is no vaccine on the market to protect against the virus. Palivizumab is a monoclonal antibody, licensed and sold by Medimmune as Synagis® that targets the RSV F protein and is used to prevent RSV disease in high risk infants.
Vaxart also presented data from a recent Phase 1 human clinical study demonstrating that its H1N1 influenza tablet vaccine generated both neutralizing antibodies as well as a robust mucosal immune response in 92 percent of subjects after a single dose.
"We now have obtained positive results for three important oral vaccine candidates – influenza, norovirus and RSV, further validating the Vaxart platform," said Wouter Latour, M.D., chief executive officer at Vaxart. "Our vaccines are administered by tablet, which would make it much easier to distribute and administer the vaccine, particularly in large vaccination campaigns such as for annual flu. In addition, in the Phase 1 clinical study that was recently published in The Lancet Infectious Diseases, our H1N1 influenza tablet vaccine generated both systemic and mucosal immune responses, suggesting our vaccine may also provide broader protection. Because our RSV vaccine is based on the same platform, we anticipate it will generate similarly broad responses, and we look forward to evaluating the RSV tablet vaccine Phase 1 clinic trials in 2016."
Vaxart is a privately held, clinical-stage company developing a range of tablet vaccines based on its proprietary oral recombinant vaccine platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration, are easy to administer, and eliminate risk of needle-stick injury and medical waste associated with injectable vaccines. For more information, please visit www.vaxart.com.
Vaxart's lead programs include tablet vaccine candidates for seasonal influenza and RSV, as well as norovirus.
Katie Hogan, 415-658-9745