Vaxart Announces Publication in Vaccines of Non-Human Primate Preclinical Data Demonstrating Its Next-Generation Vaccine Candidates Elicit Mucosal and Systemic Immunogenicity and Reduce Viral Shedding after SARS-CoV-2 Challenge
2024年2月5日 - 10:00PM
Vaxart, Inc. (Nasdaq: VXRT) today announced the publication of
preclinical non-human primate data demonstrating the potential of
its COVID-19 vaccine to protect against multiple SARS-CoV-2
variants of concern (VOC)s. The data, which were previously
presented at the International Congress of Mucosal Immunology 2022,
are reported in the current issue of Vaccines.
“Our preclinical and clinical research laid the
foundation for our next steps in testing our SARS-CoV-2 vaccine
platform against emerging viral variants,” said Dr. Sean Tucker,
Vaxart’s Founder and Chief Scientific Officer. “The data published
in Vaccines support the potential of our vaccine platform to
stimulate potent mucosal cross-reactive IgA responses to multiple
VOCs and reduce viral transmission. We believe this platform has
the potential to transform the landscape not only for COVID-19
vaccines, but for other infectious diseases that present
significant global public health challenges, such as norovirus and
influenza.”
The data included in this publication add to the
body of evidence that has guided the clinical development of
Vaxart’s COVID-19 oral vaccine program. Vaxart’s preparation for a
Phase 2b trial of its COVID-19 XBB vaccine candidate is supported
by a recent grant awarded by the United States Biomedical Advanced
Research and Development Authority (BARDA).
In the study published in Vaccines, non-human
primates were prime-boost immunized 29 days apart with vaccine
candidates either expressing the parental spike protein alone
(Wuhan-S), spike plus nucleocapsid (Wuhan-S+N), or the spike
protein from the beta variant (beta-S) of SARS-CoV-2. Key findings
from the study include:
- All three vaccines elicited strong
cross-reactive systemic immunity as evidenced by increases in serum
IgG and IgA responses.
- All three vaccines elicited robust
cross-reactive nasal and lung IgA following mucosal
vaccination.
- All three vaccines induced
neutralizing antibodies in both the peripheral and mucosal
compartments, which was enhanced with a boost immunization.
- Mucosal administration of the
vaccines elicited antigen-specific T-cells.
- Viral replication and infectious
particle shedding were significantly reduced in immunized animals
after challenge with beta variant SARS-CoV-2.
These results suggest that delivering rAd5
vaccines to a mucosal surface is an alternative immunization
approach that may generate both serum and mucosal responses, while
protecting against infection and reducing shedding. Vaxart believes
these data support the potential for its vaccines to enhance
mucosal responses and reduce community transmission, in addition to
preventing severe disease. Vaxart has previously shown its
room-temperature stable mucosal vaccines are easy to administer,
store and distribute, which could support vaccine equity and the
effectiveness of global public health responses to the continually
evolving COVID-19 pandemic.
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 and
the timing of such results, vaccine efficacy and safety,
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 the timing of receiving and reporting such 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
Relations:Mark HerrVaxart, Incmherr@vaxart.com(203)
517-8957
Investor Relations:Andrew BlazierFINN
PartnersIR@vaxart.com(646) 871-8486
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