SOUTH SAN FRANCISCO, Calif.,
Oct. 26, 2021 /PRNewswire/ -- Vaxart,
Inc. (NASDAQ: VXRT) today announced that it has dosed the
first subject in its Phase II COVID-19 oral tablet vaccine clinical
trial, the only Phase II trial of an oral tablet COVID-19 vaccine
underway in the world.
Vaxart expects to enroll 96 subjects at four sites in
the United States in the first
part of its Phase II trial. The U.S. trial will be followed by an
international trial involving a larger pool of subjects. The U.S.
portion of the trial will be a randomized open-label dose and age
escalation lead-in segment in naïve and previously vaccinated
subjects, to be followed by an international placebo-controlled
efficacy trial. The full data set from the U.S. trial is
expected in Q1 2022.
"Dosing the first subjects with the most advanced oral tablet
COVID-19 vaccine candidate marks another important step forward
toward developing a transformative solution to the SARS-CoV-2
global pandemic," said Andrei
Floroiu, Vaxart's Chief Executive Officer.
"Vaxart's oral vaccine has the potential to transform public
health both in the United States
and globally by getting more people vaccinated faster while also
offering broader protection by triggering mucosal immunity. This
could help us fight emerging strains, break through the barriers to
herd immunity and move toward domestic and global vaccine equity,"
Floroiu said.
"A vaccine that can inhibit infection in the mucosal surfaces
provides potentially better protection against airborne viruses
because the mucosa is the body's first line of defense against
these pathogens," said Dr. Sean
Tucker, Vaxart's founder and Chief Scientific Officer. "The
mucosa is where the virus invades, and if we can stop it there, we
can keep people healthier and fight off this virus and its
variants."
Manufacturing Update
Vaxart has recently brought online its own GMP manufacturing
facility and is now producing vaccines at two GMP plants in
parallel. This allowed the company to manufacture all of the
COVID-19 vaccine oral tablets for the clinical trials planned to
start in 2021, and to start manufacturing vaccines for its upcoming
norovirus Phase II trials.
Recent Pre-clinical Data
A Duke University-led study
published earlier this month showed that Vaxart's vaccine candidate
reduced the airborne transmission of SARS-CoV-2 virus in an animal
model and suggested the vaccine candidate would support superior
mucosal protection.
The study's findings, published by bioRxiv, are
consistent with those from Vaxart's Phase II human flu challenge
study published in 2020. The flu study showed Vaxart's oral tablet
flu vaccine was better at reducing shedding than the injectable flu
vaccine competitor. The Duke and flu
studies' data support the thesis that mucosal vaccines may offer
better protection than injectable vaccines against airborne
viruses.
VXA-COV2-1.1-S Phase II Trial Design
The Phase II
study is designed to enroll 96 subjects aged 18-55 years old, and
then enroll subjects aged 56-75 years old, in eight subgroups.
Subjects will be randomized into eight cohorts stratified by age,
vaccination history, dose size and placebo. The study drug will be
an oral tablet administered on Days 1 and 29. The endpoints are
safety, immunogenicity and efficacy. For more information, refer
to ClinicalTrials.gov (NCT 05067933).
About Vaxart
Vaxart 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. Vaxart's 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 immune-oncology indication. Vaxart has filed broad domestic
and international patent applications 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, and 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, including its vaccine
booster products; Vaxart's expectations regarding clinical results
and trial data; and Vaxart's expectations with respect to the
effectiveness of its product candidates. 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 or its partners
may experience manufacturing issues and delays due to events
within, or outside of, Vaxart's or its partners' control;
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.
Contacts
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Vaxart Media
Relations:
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Investor
Relations:
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Mark Herr
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IR@Vaxart.com
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Vaxart,
Inc.
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mherr@vaxart.com
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(203)
517-8957
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SOURCE Vaxart, Inc.