Shares of Vaxart (Nasdaq: VXRT) rose on Monday after the biotech said the U.S. Food and Drug Administration (FDA) had cleared its Investigational New Drug (IND) application for its oral coronavirus vaccine. As of 2:20 p.m. EDT, Vaxart's stock price was up more than 12%.
Vaxart's S-only vaccine construct produced higher serum antibodies than its other vaccine candidate, which expresses both S and N proteins, in a non-human primate study. Vaxart plans to begin a phase II clinical trial for its S-only vaccine later this year.
"This new clinical trial will allow us to compare the S-only and S+N vaccine candidates and put us in a position to decide which approach offers the best way forward for our COVID-19 vaccine development program, particularly in the face of emerging variant strains," Vaxart's chief scientific officer Dr. Sean Tucker said in a press release.
If Vaxart's new vaccine construct can produce a stronger antibody response in human patients than its other oral vaccine did in prior studies, it could become a more legitimate competitor to the COVID-19 drugs developed by Pfizer and Moderna. As a tablet, Vaxart's oral vaccine would be easier to store, transfer, and administer. If Vaxart can demonstrate a comparable efficacy and safety profile to the leading vaccines currently on the market, there would likely be tremendous demand for its new drug.