Vaxart New Drug Application for S-Only Tablet Covid-19 Vaccine Candidate Cleared by FDA
August 02 2021 - 08:51AM
Dow Jones News
By Robb M. Stewart
Vaxart Inc. will begin a clinical trial of its S-only oral
tablet Covid-19 vaccine candidate in the second half of the year
after the U.S. Food and Drug Administration cleared its
investigational new drug application.
The biotechnology company on Monday said preliminary data from a
non-human primate study indicates that the S-only vaccine produced
much higher serum antibodies than the one expressing both S and N
proteins. A planned Phase 2 trial would allow Vaxart to compare the
S-only and S+N vaccine candidates to help decide which approach
offers the best way forward in its Covid-19 vaccine-development
program, particularly given emerging variant strains.
In premarket trading, Vaxart's shares were 14% higher after
ending Friday at $7.19, up 26% since the end of last year.
In February, Vaxart said it had completed a Phase 1 clinical
trial for its oral S+N COVID-19 vaccine, the results of which 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.
"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," said Sean Tucker, Vaxart's
chief scientific officer.
The company said the development of the S-only oral tablet and
other S-only constructs will proceed in parallel with the S&N
construct.
Write to Robb M. Stewart at robb.stewart@wsj.com
(END) Dow Jones Newswires
August 02, 2021 08:37 ET (12:37 GMT)
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