New Preclinical Data Demonstrate Two of Vaxart’s COVID-19 Vaccine Candidates Protect Against Omicron
June 03 2022 - 08:00AM
GlobeNewswire Inc.
Vaxart, Inc. (NASDAQ: VXRT) today reported positive preliminary
preclinical data demonstrating that two COVID-19 vaccine candidates
targeting either the SARS-CoV-2 spike (S) protein for Wuhan or S
protein for Omicron protected hamsters when challenged with the
Omicron BA.1 variant.
“Approved COVID-19 vaccines afford less protection against
infection from new SARS-CoV-2 variants compared with the original
parental strain against which they were developed. A broadly
cross-reactive vaccine may be the most effective way to protect
against current and future variants,” said Dr. Sean Tucker,
Vaxart’s SVP and Chief Scientific Officer. “We developed an Omicron
specific vaccine candidate and compared it with our original Wuhan
strain vaccine candidate that is currently in Phase II clinical
trials. The study showed both vaccines could protect against
Omicron challenge in a key preclinical model.”
The data reported today are from a study in which the S-only
Wuhan and Omicron vaccine candidates were compared in a hamster
challenge model.
- Animals were immunized mucosally on days zero and 28 and
challenged on day 56 with an Omicron variant of SARS-CoV-2
- Both vaccines produced antibody responses to the S protein of
Omicron, with the Omicron candidate slightly better at making serum
IgG antibodies to the matched protein
- Weight loss, lung viral titers, and viral shedding were reduced
in animals receiving either vaccine candidate compared to
unvaccinated animals
These findings demonstrate that in this preclinical model both
vaccine candidates protect against the Omicron variant.
Earlier this year, Vaxart announced that data from its non-human
primate study showed that the S-only candidate generated antibodies
to the original COVID-19 Wuhan strain and those antibodies also
react strongly with the Beta, Delta, Alpha and Gamma variants of
SARS-CoV-2 in the serum and nasal mucosa of non-human primates. In
May 2021, the Company announced Phase I clinical test results
demonstrating that its oral vaccine candidate, VXA-CoV2-1, which
targets both the S and N proteins, produced broad cross-reactive T
cell and IgA responses against other, non-COVID coronaviruses.
Vaxart continues to use pre-clinical and clinical data in
conjunction with information on the evolution of the pandemic to
make decisions on the COVID-19 vaccine candidates to move forward
in its clinical development path.
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 preclinical 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,"
“anticipate,” "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.ContactsVaxart Media
RelationsMark HerrVaxart, Inc.mherr@vaxart.com(203)
517-8957
Investor RelationsAndrew BlazierFINN
PartnersIR@Vaxart.com(646) 871-8486
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