Vaxart Publishes Clinical Data Suggesting its Oral COVID-19 Pill Vaccine Candidate Induces Long-Lasting Mucosal Immune Responses that are Highly Cross-Reactive
July 20 2022 - 7:30AM
Vaxart (NASDAQ: VXRT) today reported additional phase 1 clinical
data published on medRixv.org, indicating that its
Spike/Nucleocapsid (S+N) oral tablet COVID-19 vaccine induced
long-lasting mucosal IgA antibodies against SARS-CoV-2 the virus
that causes COVID-19, and all tested coronaviruses. The
neutralizing activity of these IgA antibodies in responders was
higher than that measured in convalescent samples.
Vaxart had previously disclosed results from
this study showing its vaccine candidate was well-tolerated and
immunogenic. This additional data supports its potential to improve
immune responses at mucosal surfaces and improve public health
responses to the COVID-19 pandemic. Vaxart intends to publish the
complete data from the study in a peer-reviewed journal.
“One of the most important challenges with
current COVID-19 vaccine strategies is that injected vaccines
stimulate robust serum antibody responses against the Wuhan strain
of SARS-CoV-2, but these responses quickly decline, and they are
not as effective against the currently circulating viral variants.
This has resulted in breakthrough infections in many people who
have received injected vaccines,” said the article’s lead author,
Dr. Sean Tucker, Vaxart’s SVP and Chief Scientific Officer.
“Our clinical study results showed that our
vaccine candidate stimulates broadly cross-reactive mucosal IgA
responses that persist for at least 6 months in most responders,
and up to a year in a subset of them following just a single dose.
Two key observations in this study were that vaccination induced a
similar mucosal IgA response as seen in convalescent subjects, and
that the vaccinated subjects appeared to have better neutralizing
antibody potential in the mucosa than infected subjects. We are
excited to explore these aspects in depth in future studies,” he
said.
“These findings support our view that the
cross-reactivity of our vaccine candidates’ mucosal immune
responses could have a significant impact in the fight against
evolving SARS-CoV-2 variants,” Dr. James Cummings, Vaxart’s SVP and
Chief Medical Officer said. “We will continue to evaluate our
vaccine candidates in order to choose the best way forward for our
COVID-19 vaccine development program in the face of emerging
variant strains.”
About the Data
The data reported today are from a phase 1
dose-ranging, open-label clinical trial (NCT04563702) in which the
S+N vaccine candidate was evaluated in 35 healthy adult volunteers
who tested negative for SARS-CoV-2 by PCR and rapid antigen tests.
Subjects received a low dose with a boost at Day 29 or a single low
or high dose of the S+N oral tablet vaccine candidate.
Nasal samples were collected and analyzed for
SARS-CoV-2-specific IgA. In the study, 46% of subjects had at least
a 1.5-fold increase in SARS-CoV-2-specific secretory IgA compared
with pre-vaccination levels. In a separate study, nasal and saliva
samples were collected from individuals with prior SARS-CoV-2
infection. Analysis of nasal and saliva samples for neutralizing
activity (sVNT) against SARS-CoV-2 showed that 50% of the
vaccinated subjects had more neutralizing activity than those with
prior infections, and this enhanced neutralizing capacity persisted
6 months post vaccination.
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 pills that can be stored and shipped without refrigeration
and eliminate the risk of needle-stick
injury. Vaxart believes that its proprietary pill 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 pill
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
StatementsThis 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. Contacts
Vaxart Media
RelationsMark HerrVaxart, Inc.mherr@vaxart.com(203)
517-8957
Investor Relations Andrew
BlazierFINN Partners IR@Vaxart.com(646) 871-8486
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Apr 2024 to May 2024
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From May 2023 to May 2024