Vaxart’s Oral COVID-19 Vaccine Candidate Induces Potent Systemic and Mucosal Immune Responses in Preclinical Studies - Seite 2
Study Design
The study was designed to assess the relative immunogenicity of four candidate vaccines expressing multiple combinations of the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus in a
standard mouse model. While all candidates demonstrated the ability to elicit a strong immune response, the most successful candidate contained the full length S and N proteins. While the S protein
is responsible for receptor binding, membrane fusion, and tissue tropism and a major target for neutralizing antibodies, targeting full length S protein in combination with N protein may prevent
future vaccine-driven escape due to the accumulation of mutations in the S protein. The inclusion of N protein in the vaccine candidate provides additional conserved T epitopes. Further, the
induction of polymeric IgA at mucosal surfaces may be superior for generating neutralizing antibodies against divergent viruses.
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 administered using convenient room
temperature-stable tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart has demonstrated 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. Its
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 immuno-oncology indication. Vaxart has filed broad domestic and international patents covering its proprietary technology and creations for oral
vaccination using adenovirus and TLR3 agonists.
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regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are
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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 preclinical or clinical
results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations regarding the timing and nature of future announcements including, those related to
clinical trials; Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for coronaviruses; the
potential applicability of results seen in a mouse model to those that may be seen in human studies or clinical trials; the expected role of mucosal immunity in blocking transmission of COVID-19;
and Vaxart’s expectations with respect to the effectiveness of its products or product candidates, including Vaxart’s potential role in mitigating the impact of COVID-19 globally. 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, including the recent outbreak of COVID-19; 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 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.