SOUTH SAN FRANCISCO, Calif., Aug. 2, 2021 /PRNewswire/ -- Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines administered by tablet, announced today that the U.S. Food and Drug Administration has cleared Vaxart's Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate.
"This is great news because it allows us to move forward with our first S-only vaccine construct," said Andrei Floroiu, Vaxart's Chief Executive Officer. "As we said at the end of the first quarter, we will explore multiple S-only constructs in clinical trials alongside the S+N construct that has already completed its Phase I trial.
"Together, the S-only and S+N constructs are part of our unique oral tablet COVID-19 vaccine candidate portfolio, which we believe could make a significant contribution to the fight against COVID-19 globally."
"Preliminary data from our current Non-Human Primate study indicates that the S-only vaccine produced much higher serum antibodies than the one expressing both S and N proteins," said Dr. Sean Tucker, Vaxart's Chief Scientific Officer. "Our Phase I results from the S+N vaccine candidate showed remarkable T-cell responses and a mucosal antibody response, but not as strong serum antibody responses.
"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 announced in February that it had completed a Phase 1 clinical trial for its oral S+N COVID-19 vaccine. The results from that study found that the investigational oral vaccine triggered multiple immune responses against SARS-CoV-2 antigens, while reaching primary and secondary endpoints of safety and immunogenicity, respectively.
The Phase II clinical trial with the S-only construct is expected to start in 2H21.