Vaxart Announces Additional Positive Pre-Clinical Data for its Oral COVID-19 Vaccine Program
April 30 2020 - 8:00AM
Vaxart, Inc., a clinical-stage biotechnology company developing
oral recombinant vaccines that are administered by tablet rather
than by injection, today announced that it has obtained positive
pre-clinical results for its COVID-19 vaccine candidates, with
several of the vaccine candidates generating immune responses in
all tested animals after a single dose.
“These pre-clinical results confirm that all constructs are
immunogenic as measured by IgG antibodies in serum, and we observed
a robust boosting effect after the second dose.” said Sean Tucker,
Ph.D., chief scientific officer of Vaxart. “This latest data set
will help to select the lead candidate for manufacturing, and we
remain on track to start a first phase 1 study in the second half
of this year.”
In January 2020, Vaxart initiated a program to develop a
COVID-19 vaccine based on its VAASTTM oral vaccines platform. The
Company is currently evaluating multiple vaccine candidates in its
preclinical models. In this second round of preclinical testing,
all animals received two doses of the Vaxart vaccines, two weeks
apart. Antibody responses in all vaccinated groups were
statistically significant compared to the untreated controls.
Vaxart plans to select one or more vaccine candidates for cGMP
manufacturing and clinical testing based on the magnitude and the
breadth of the immune response.
“Our oral vaccines have been shown to protect against
respiratory infection based on mucosal immunity, the first line of
defense for such infections, as recently published in the Lancet
Infectious Diseases,” said Wouter Latour, MD, chief executive
officer of Vaxart Inc. “This could be important for an effective
vaccine that protects the global population from COVID-19. In
addition, the Vaxart vaccine would be administered orally using a
room temperature-stable tablet, an enormous logistical advantage
over injectables in large vaccination campaigns.”
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, including Emergent’s ability to produce bulk cGMP
vaccine and the timing thereof; and Vaxart’s expectations with
respect to the important advantages it believes its oral vaccine
platform can offer over injectable alternatives, particularly for
mucosal pathogens such as norovirus, flu and RSV, as well as
coronaviruses such as SARS, MERS and SARS CoV-2. 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
3500IR@vaxart.com
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