FDA OKs Vaxart's IND Application For S-Only Oral Tablet SARS-CoV-2 Vaccine Candidate - Quick Facts

Biotechnology company Vaxart, Inc. (VXRT) announced Monday 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.

The vaccine candidate expressing S-only protein produced higher serum antibodies than the one expressing both S and N proteins in a Non-Human Primate study. The Phase II clinical trial with the S-only construct is expected to start in the second half of 2021.

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.

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