Vaxart Shares Jump After FDA Clearance of Investigational New Drug Application
By Robb M. Stewart
Vaxart Inc.'s shares climbed in early trading Monday after the
U.S. Food and Drug Administration cleared its investigational new
drug application for a tablet Covid-19 vaccine candidate.
In morning trading, the shares were 11% stronger at $7.95,
widening the year-to-date gain to 39%.
The biotechnology company Monday said it will begin a Phase II
clinical trial of its S-only oral tablet vaccine candidate in the
second half of the year.
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, the company said. The planned
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, it said.
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
Write to Robb M. Stewart at email@example.com
(END) Dow Jones Newswires
August 02, 2021 10:13 ET (14:13 GMT)
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