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
- Promising preclinical non-human primate data supporting the potential of Vaxart's COVID-19 vaccine to protect against multiple SARS-CoV-2 variants of concern.
- Support for the vaccine platform's potential to stimulate potent mucosal cross-reactive IgA responses to multiple VOCs and reduce viral transmission.
- Preparation for a Phase 2b trial of its COVID-19 XBB vaccine candidate supported by a recent grant awarded by BARDA.
- All three vaccines elicited strong cross-reactive systemic immunity and robust cross-reactive nasal and lung IgA following mucosal vaccination.
- Reduced viral replication and infectious particle shedding in immunized animals after challenge with the beta variant of SARS-CoV-2.
- None.
Insights
The reported preclinical findings from Vaxart, Inc. regarding their COVID-19 vaccine candidates present a significant development in the field of vaccine research. The ability of the vaccine to elicit strong serum IgG and IgA responses suggests a robust systemic immune response. Moreover, the generation of neutralizing antibodies and the reduction of viral shedding in non-human primates after mucosal administration indicate a potential for effective mucosal immunity, which is crucial for blocking both infection and transmission of respiratory viruses.
The focus on mucosal vaccination is particularly noteworthy as it represents a shift from traditional intramuscular injections. Mucosal vaccines can stimulate local immunity in the respiratory tract, which is the primary entry point for many pathogens, including SARS-CoV-2. The potential for this vaccine to reduce community transmission could be a game-changer in managing outbreaks and pandemics. Additionally, the vaccine's stability at room temperature could greatly enhance distribution and accessibility, addressing a significant barrier in global vaccination efforts.
From an epidemiological standpoint, the ability of Vaxart’s vaccine candidates to protect against multiple variants of concern (VOCs) is of high importance. VOCs often exhibit mutations that can lead to increased transmissibility and escape from immune protection. The reported cross-reactive immunity is crucial for a vaccine to remain effective as the virus evolves. The reduction of viral shedding in vaccinated individuals is an important factor in controlling the spread of the virus within communities.
Furthermore, the transition to mucosal vaccines could have a profound impact on public health strategies. Traditional systemic vaccines are less effective at inducing mucosal immunity. A vaccine that effectively induces mucosal responses could improve protection against initial infection and reduce asymptomatic spread, a vital aspect in the containment of respiratory infectious diseases.
In the context of the market, Vaxart’s advancements could position the company as a notable player in the vaccine industry, especially if their oral vaccine candidates prove effective in Phase 2 trials. The company's innovative oral vaccine platform may attract attention from investors and partners looking for next-generation vaccine technologies. The support from the United States Biomedical Advanced Research and Development Authority (BARDA) further validates the potential of Vaxart's vaccine candidates.
The emphasis on a vaccine that is easy to administer, store and distribute aligns with the global need for more equitable vaccine solutions. Should the vaccine candidates succeed in clinical trials, Vaxart could see an increase in market share and interest from international health organizations seeking to diversify their vaccine portfolios, particularly for low-resource settings.
— Data served as foundation for current vaccine candidate for planned Phase 2 research
— Vaxart vaccine candidates elicited strong antigen-specific serum IgG and IgA with neutralizing activity against multiple variants of concern
— Vaccination reduced SARS-CoV-2 shedding following infectious challenge in both the upper and lower airway of non-human primates
SOUTH SAN FRANCISCO, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- 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 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 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 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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