Vaxart Announces IND Filed for COVID-19 Vaccine

SOUTH SAN FRANCISCO, CA, USA I August 10, 2020 I Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that its COVID-19 Investigational New Drug (IND) application has been filed with the US Food and Drug Administration (FDA).

“We are very excited to reach this important milestone in advancing our oral COVID-19 vaccine candidate towards the clinic,” said Andrei Floroiu, chief executive officer of Vaxart. “We expect our upcoming Phase I study to generate data that will further differentiate our oral vaccine from injectable vaccines by substantiating the importance of activating both systemic and mucosal immunity in protecting against COVID-19.  We believe that this mechanistic benefit combined with the significant advantages of oral administration to the patient while eliminating the need for cold chain distribution, could make our COVID-19 vaccine an ideal candidate for successful mass vaccination campaigns globally.”

“Filing the IND is the first major step of many we are taking to advance our oral vaccine in the prevention of COVID-19,” said Sean Tucker, Ph.D., chief scientific officer of Vaxart. “We are excited to be moving this project toward clinical trials, and potentially demonstrating similarly potent mucosal and systemic immune responses like we have seen with our other vaccine candidates using the same oral tablet vaccine platform.”

About Vaxart

Vaxart is a clinical-stage biotechnology company focused on developing oral tablet vaccines designed to generate mucosal and systemic immune responses that protect against a wide range of infectious diseases and have the potential to provide sterilizing immunity for diseases such as COVID-19. Vaxart believes that a room temperature stable tablet is easier to distribute, store and administer than injectable vaccines and may provide a significantly faster response to a pandemic than injectable vaccines, enabling a greater portion of the population to be protected. Vaxart’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV). For more information, please visit www.vaxart.com.

SOURCE: Vaxart

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