Vaxart announces the publication of studies in the Peer-Reviewed Journal of Translation Science Medicine that suggest that mucosal immunization could reduce SARS-CoV-2 transmission

Vaxart announces the publication of studies in the Peer-Reviewed Journal of Translation Science Medicine that suggest that mucosal immunization could reduce SARS-CoV-2 transmission


Vaxart, Inc.

A preclinical study in hamsters showed both a decrease in infectivity virus and in transmission

Phase 1 data measuring cross-reactivity is also included in the publication

SOUTH SAN FRANCISCO, Calif., May 19, 2022 (GLOBE NEWSWIRE) – Science, translational medicine published the results of a preclinical transmission study in hamsters conducted by Duke University, which found that the candidate oral vaccine COVID-19 only S from Vaxart (NASDAQ: VXRT) inhibited SARS-CoV-2 transmission. The report also describes updated results from a Vaxart phase I clinical trial, suggesting that another Vaxart vaccine candidate targeting both S and N proteins could be effective against a number of different coronaviruses.

The study compared different measurements of immunity and virus excretion in hamsters of hamsters immunized with the candidate vaccine Vaxart S alone (given orally and intranasally), intramuscular protein vaccine and placebo. Vaccinated hamsters were then infected with high doses of SARS-CoV-2 to break through the vaccine and exposed to naive animals during the breakthrough period. The study’s authors concluded that Vaxart’s S-construct only “reduced disease and reduced airborne transmission in the hamster model.”

The publication also reports the results of a phase I clinical trial of the Vaxart S + N vaccine, which showed that it stimulated SARS-CoV-2-specific IgA antibodies in saliva and nasal samples from human subjects and was cross-reactive with many different coronaviruses that are different from circulating variants of SARS-CoV-2.

“Publication of these results in a highly respected, peer-reviewed journal, such as Science, translational medicine underlines the potential value of Vaxart’s COVID-19 oral vaccine platform in addressing many aspects of the COVID-19 pandemic, “said Dr. Sean Tucker, Chief Scientific Officer of Vaxart and lead author.

S-only data from a preclinical study of hamster transmission were originally published last October in the non-peer-reviewed journal bioRxiv. Vaxart first announced the potential cross-reactive properties of its S + N vaccine candidate in May 2021. Science, translational medicine The publication provides further details regarding IgA antibody responses in human subjects.

Vaxart has entered Phase II clinical trials with only S vaccine candidate and expects to report these results later this year. Vaxart also completed and published preliminary Phase I results from its S + N vaccine candidate. As already mentioned, the company plans to compare vaccine candidates with only S and S + N and decide which approach offers the best way forward for its COVID-19 vaccine development program, especially in the face of emerging variant strains.

Hamster study
The results of a preclinical study conducted by Duke University, Lovelace Biomedical and Vaxart showed that the candidate vaccine Vaxart only S stimulates mucosal IgA and serum IgG antibodies and can reduce SARS-CoV-2 infection and airborne transmission. Reducing transmission is important to protect unvaccinated individuals, including nearly 34% of Americans who are not fully vaccinated.1

“The recent outbreak of COVID-19 variants has shown that vaccinated individuals who become infected with SARS-CoV-2 can transmit the virus to unvaccinated members of their family and community, which contributes significantly to public health threats,” said Dr. Stephanie Langel, Scientist and Medical Instructor at Duke University and first author of the publication. “A vaccine that protects against infection and limits transmission would provide significant benefits for personal and public health. In addition, the oral vaccine has the potential to address vaccination reluctance among individuals who refuse to inject, which could help increase overall vaccination coverage.

Phase I Study
In a phase I study, subjects with at least a two-fold increase in virus-specific IgA also showed an increase in IgA antibodies that cross-reacted with a number of other coronaviruses. This broad cross-reactivity has the potential to provide increased protection against COVID-19 variants compared to injectable vaccines, which largely stimulate serum IgG responses. Data from a phase I study also showed that Vaxart’s S + N vaccine candidate stimulated strong T cell responses, particularly CD8 + T cells.

The Phase I clinical study was designed to evaluate the safety and immunogenicity of the Vaxart COVID-19 S + N oral vaccine candidate in 35 subjects. Participants received one high dose (n = 15), one low dose (n = 15), or two low doses (n = 5) of the vaccine. IgA levels in saliva and nasal samples were assessed 29 days after vaccination. More than half (54%) of the subjects had at least a 2-fold increase in IgA antibodies in either saliva or nasal samples. The responses were similar for the S and N proteins, as well as for the receptor-binding domain. Subjects with at least a 2-fold increase in virus-specific IgA in saliva or nasal specimens also showed an increase in cross-reactive IgA, which binds to spike proteins from four endemic coronavirus strains as well as coronavirus respiratory syndrome in the Middle East (MERS -CoV) and SARS-CoV-1. . The observed reactions did not differ between doses.

Link
1 US Centers for Disease Control and Prevention. COVID-19 vaccination in the United States. Available at: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total

About Vaxart
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its own delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and transported without refrigeration, eliminating the risk of needlestick injuries. Vaxart believes that its own tablet vaccine delivery platform is suitable for the delivery of recombinant vaccines, which allows the company to develop oral versions of currently sold vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include tablet vaccines to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncological indication. Vaxart has filed a wide domestic and international patent application covering its patented technology and creations for oral vaccination with adenovirus and TLR3 agonists.

Note on forward-looking statements
This press release contains forward-looking statements that involve significant 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 of preclinical and clinical studies, commercialization and licensing agreements, and management’s beliefs and expectations are forward-looking statements. These forward-looking statements may be accompanied by words such as “should”, “believe”, “could”, “potential”, “will”, “expected”, “anticipate”, “plan” and other words and conditions of similar meaning. Examples of such statements include, but are not limited to, statements regarding Vaxart’s ability to develop and commercialize its product candidates, including its enhancement products; Vaxart’s expectations regarding clinical results and study data; and Vaxart’s expectations with regard to the effectiveness of its product candidates. Vaxart may not actually achieve its plans, realize its intentions or meet the expectations or projections set forth in the forward-looking statements, and you should not rely too much on those forward-looking statements. Actual results or events may differ materially from plans, intentions, expectations and projections published in forward-looking statements. Various important factors could cause actual results or events to differ materially from Vaxart’s forward-looking statements, including research and development uncertainties, including the ability to meet expected clinical endpoints, clinical trial start and / or completion dates, regulatory submission dates, regulatory approval dates and / or launch dates, as well as the possibility of adverse new clinical data and further analysis of existing clinical data; the risk that data from clinical trials are subject to different interpretations and evaluations by regulatory authorities; whether regulatory authorities are satisfied with the design and results of clinical trials; regulatory decisions affecting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart candidates may not be approved by the FDA or non-US regulators; whereas, even if approved by the FDA or non-US regulators, candidates for Vaxart products may not gain widespread market acceptance; that a Vaxart associate may not reach development and commercial milestones; that Vaxart or its partners may experience production issues and delays due to events within or outside the control of Vaxart or its partners; production difficulties, especially in expanding initial production, including difficulties in production costs and revenues, quality control, including product candidate stability and quality assurance testing, lack of qualified personnel or key raw materials, and compliance with strictly enforced federal and state regulations; that Vaxart may not be able to obtain, maintain and enforce the necessary patents and other intellectual property protection; that Vaxart’s capital resources may be insufficient; Vaxart’s ability to resolve outstanding legal matters; Vaxart’s ability to raise sufficient capital to finance its operations under conditions acceptable to Vaxart, if at all; the impact of government proposals and health policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s quarterly and annual reports filed with the SEC. Vaxart assumes no obligation to update any forward-looking statements, except as required by law.

Contacts

Vaxart Media Relations
Mark Herr
Vaxart, Inc.
mherr@vaxart.com
(203) 517-8957

Investor relations
Andrew Blazier
FINN partners
IR@Vaxart.com
(646) 871-8486



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