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.
About Vaxart
Vaxart (www.vaxart.com) is a clinical-stage biotechnology
company developing a range of oral recombinant vaccines based on
its proprietary delivery platform. Vaxart vaccines are
designed to be administered using tablets that can be stored and
shipped without refrigeration and eliminate the risk of
needle-stick injury. Vaxart believes that its proprietary
tablet vaccine delivery platform is suitable to deliver recombinant
vaccines, positioning the company to develop oral versions of
currently marketed vaccines and to design recombinant vaccines for
new indications. Its development programs currently include tablet
vaccines designed to protect against coronavirus, Norovirus,
seasonal influenza and respiratory syncytial virus (RSV), as well
as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's
first immuno-oncology indication. Vaxart has filed broad
domestic and international patents covering its proprietary
technology and creations for oral vaccination using adenovirus and
TLR3 agonists.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. All statements, other
than statements of historical facts, included in this press release
regarding Vaxart's strategy, prospects, plans and objectives,
results from pre-clinical and clinical trials, commercialization
agreements and licenses, beliefs and expectations of management are
forward-looking statements. These forward-looking statements may be
accompanied by such words as "should," "believe," "could,"
"potential," "will," "expected," "plan" and other words and terms
of similar meaning. Examples of such statements include, but are
not limited to, statements relating to Vaxart's ability to develop
and commercialize its product candidates and clinical results and
trial data; Vaxart's expectations with respect to the important
advantages it believes its oral vaccine platform can offer over
injectable alternatives for SARS-CoV-2; expectations regarding
Vaxart's ability to develop effective vaccines against new and
emerging variant strains; and Vaxart's expectations with respect to
the effectiveness of its product candidates, including Vaxart's
potential role in mitigating the impact of
Covid-19. Vaxart may not actually achieve the plans,
carry out the intentions or meet the expectations or projections
disclosed in the forward-looking statements and you should not
place undue reliance on these forward-looking statements. Actual
results or events could differ materially from the plans,
intentions, expectations and projections disclosed in the
forward-looking statements. Various important factors could cause
actual results or events to differ materially from the
forward-looking statements that Vaxart makes, including
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical , regulatory submission dates,
regulatory approval dates and/or launch dates, as well as the
possibility of unfavorable new clinical data and further analyses
of existing clinical data; the risk that clinical trial data are
subject to differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from the clinical studies; decisions by
regulatory authorities impacting labeling, manufacturing processes,
and safety that could affect the availability or commercial
potential of any product candidate, including the possibility that
Vaxart's product candidates may not be approved by the FDA or
non-U.S. regulatory authorities; that, even if approved by the
FDA or non-U.S. regulatory authorities, Vaxart's product
candidates may not achieve broad market acceptance; that
a Vaxart collaborator may not attain development and
commercial milestones; that Vaxart or its partners may
experience manufacturing issues and delays due to events within, or
outside of, Vaxart's or its partners control, including the recent
outbreak of Covid-19; difficulties in production, particularly in
scaling up initial production, including difficulties with
production costs and yields, quality control, including stability
of the product candidate and quality assurance testing, shortages
of qualified personnel or key raw materials, and compliance with
strictly enforced federal, state, and foreign regulations;
that Vaxart may not be able to obtain, maintain and
enforce necessary patent and other intellectual property
protection; that Vaxart's capital resources may be inadequate;
Vaxart's ability to resolve pending legal matters; Vaxart's ability
to obtain sufficient capital to fund its operations on terms
acceptable to Vaxart, if at all; the impact of government
healthcare proposals and policies; competitive factors; and other
risks described in the "Risk Factors" sections of Vaxart's
Quarterly and Annual Reports filed with
the SEC. Vaxart does not assume any obligation to
update any forward-looking statements, except as required by
law.
Contact
Vaxart Media
Relations:
Mark
Herr
Vaxart,
Inc.
(203)
517-8957
mherr@vaxart.com
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SOURCE Vaxart, Inc.