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 norovirus vaccine candidate elicited substantial systemic and mucosal immune responses to norovirus in preclinical studies. The data were presented at the 16th Annual World Vaccine Congress in Madrid, Spain.
“We evaluated our oral vaccine in large and small animal studies, and compared it to an injectable VLP-based vaccine. The oral vaccine induced a robust systemic antibody response equivalent to that of the injectable vaccine, but only the Vaxart oral vaccine induced an intestinal mucosal immune response,” said Sean Tucker, Ph.D., chief scientific officer at Vaxart. “This suggests our oral vaccine may have advantages over injectable approaches, including the ability to neutralize norovirus at the site of infection.”
Norovirus is the leading cause of acute viral gastroenteritis, resulting in diarrhea and vomiting. According to the Centers for Disease Control and Prevention (CDC), norovirus causes an annual estimated 19 to 21 million illnesses and contributes to 56,000 to 71,000 hospitalizations and 570 to 800 deaths in the United States. Worldwide, norovirus causes 20 percent of diarrheal illness and as many as 100,000 deaths each year. Currently, there is no norovirus vaccine on the market.
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. “Our flu and norovirus vaccines are based on the same delivery platform, so we anticipate that our norovirus vaccine will generate systemic and mucosal immune responses in humans as well,” said Wouter Latour, MD, chief executive officer at Vaxart. “Having both responses may be critical for an effective norovirus vaccine, and really plays to the strength of the Vaxart vaccine, which is administered by tablet. Moreover, this data set further validates the value of the Vaxart platform across multiple indications, including seasonal flu, norovirus and RSV. We are looking forward to evaluating our norovirus tablet vaccine in the clinic in the coming months.”
Recently Vaxart was awarded a $13.98 million contract by the Office of Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response to support the advanced development of more effective and universal influenza vaccines to improve seasonal and pandemic influenza preparedness. The contract will primarily fund a Phase 2 challenge study in human volunteers, designed to evaluate whether the Vaxart tablet vaccine offers broader and more durable protection than currently marketed injectable vaccines. Additionally, through a series of preclinical and clinical studies, Vaxart will seek to demonstrate broad cross-protective immunity of its tablet vaccine against drifted and divergent influenza strains.
This contract will be funded in whole or in part with federal funds from the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority under Contract No. HHSO10020150034C.
Vaxart’s lead programs include tablet vaccine candidates for seasonal influenza, norovirus and Respiratory Syncytial Virus (RSV).
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.