Vaxart Announces Selection of its Oral COVID-19 Vaccine Lead Candidate
May 20 2020 - 8:00AM
Vaxart, Inc. (“Vaxart” or the “Company”) (NASDAQ: VXRT), a
clinical-stage biotechnology company developing oral recombinant
vaccines that are administered by tablet rather than by injection,
today announced that it has selected its lead COVID-19 vaccine
candidate and has contracted with KindredBio to manufacture bulk
vaccine under cGMP to complement the manufacturing capacity of
partner Emergent BioSolutions.
“All our COVID-19 vaccine constructs were highly immunogenic in
preclinical testing, and we are taking the candidate forward that
is expected to generate the broadest immune response in humans,”
said Sean Tucker, Ph.D., chief scientific officer of Vaxart. “In a
phase 2 efficacy study that was recently published in the Lancet
Infectious Diseases, we have demonstrated that our oral H1 flu
tablet vaccine protected against influenza infection after just one
dose. Based on these results, we believe our vaccines are
ideal to protect against mucosal respiratory viruses such as
SARS-CoV-2, the virus that causes COVID-19.”
In January 2020, Vaxart initiated a program to develop a
COVID-19 vaccine based on its VAASTTM oral vaccines platform. The
Company evaluated multiple vaccine candidates in its preclinical
models and has chosen the lead candidate for cGMP manufacturing and
clinical testing based on the magnitude and the breadth of the
immune response. Vaxart has contracted with Emergent BioSolutions
(“Emergent”) and Kindred Biosciences, Inc. (“KindredBio”) to
produce bulk vaccine under cGMP for upcoming clinical trials.
The vaccine tablets will be manufactured at Vaxart.
“We are very pleased to have an experienced partner such as
KindredBio to help us meet global demand for our COVID-19 vaccine,”
said Wouter Latour, MD, chief executive officer of Vaxart. “The
program with Emergent BioSolutions is progressing very well, and we
expect KindredBio will add additional capacity to help produce bulk
vaccine. An important benefit of our platform is that our
vaccines are produced in tablet form and we don’t need the sterile
fill and finish that is required for the production of injectable
vaccines. Manufacturing of our COVID-19 vaccine is on track
to start a first phase 1 study in the second half of this year,
possibly as early as the summer.”
About VaxartVaxart is a clinical-stage
biotechnology company primarily focused on developing oral
recombinant protein vaccines based on its proprietary oral vaccine
platform. Vaxart’s vaccines are designed to generate broad and
durable immune responses that protect against a wide range of
infectious diseases and may also be useful for the treatment of
chronic viral infections and cancer. Vaxart’s vaccines are
administered using a convenient room temperature-stable tablet,
rather than by injection. Vaxart believes that tablet vaccines are
easier to distribute and administer than injectable vaccines and
have the potential to significantly increase vaccination rates.
Vaxart’s development programs include oral tablet vaccines that are
designed to protect against coronavirus, norovirus, seasonal
influenza and respiratory syncytial virus (“RSV”), as well as a
therapeutic vaccine for human papillomavirus (“HPV”). For more
information, please visit www.vaxart.com.
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 (including plans with respect to the COVID-19 vaccine
product candidates); expectations relating to Vaxart’s relationship
with Emergent and KindredBio, including their ability to produce
bulk cGMP vaccine and the timing and capacity thereof; Vaxart’s
ability to manufacture vaccine tablets; the expected timing of the
first phase 1 study; expectations regarding Vaxart’s lead COVID-19
vaccine candidate; and Vaxart’s expectations with respect to the
important advantages it believes its oral vaccine platform can
offer over injectable alternatives. 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 trials, 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 may
experience manufacturing issues and delays due to events within, or
outside of, Vaxart’s control, including the recent outbreak of
COVID-19; 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 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.
ContactBrant Biehn Vaxart Inc 650 550 3500
IR@vaxart.com
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