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Vaxart's Second-Generation Oral Norovirus Vaccine Shows Up To 25-Fold Increase In Protective Fecal IgA In Phase 1 Trial

Author: Benzinga Newsdesk | September 10, 2025 05:03pm

- Second-generation constructs induce robust increases in fecal IgA, which was shown to be correlated with protection against infection in the company's previous Phase 2b challenge study -

SOUTH SAN FRANCISCO, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX:VXRT), a clinical-stage biotechnology company developing a range of oral recombinant pill vaccines based on its proprietary delivery platform, today reported additional positive data from the Phase 1 clinical trial evaluating its second-generation oral pill norovirus vaccine constructs head-to-head against its first-generation constructs. Dr. Sean Tucker, Vaxart's Founder and Chief Scientific Officer, presented the data at the 9th International Calicivirus Conference, which is taking place in Banff, Canada, September 7-11, 2025. Further, Dr. Becca Flitter presented data on Vaxart's norovirus challenge study at the same conference.

The data show a 25-fold increase in the GII.4 fecal IgA response and a 10-fold increase in the GI.I fecal IgA response over baseline with the high dose of the second-generation vaccine candidates after a single tablet administration for each strain. The data also show an 8-fold increase in the GII.4 fecal IgA response and a 7-fold increase in the GI.I fecal IgA response over baseline with the low dose of the second-generation vaccine candidates after a single tablet administration for each strain.

While the Phase 1 study was not powered to determine superiority by statistical methods, the fecal IgA increases observed with the second-generation constructs compared favorably to the increases observed with the first-generation constructs at the same high dose level and in the same study (13-fold GII.4 and 6-fold GI.1 over baseline). As previously reported, a Phase 2 challenge study of the first-generation constructs identified fecal IgA as a critical correlate to protection from norovirus infection.1

Posted In: VXRT

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