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The study reached primary and secondary safety and immunogenicity outcomes, respectively
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Potent CD8 induced by VXA-CoV2-1+ T cell responses
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VXA-CoV2-1 potentially protective against new and emerging COVID-19 strains
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Data to be presented today at the New York Academy of Sciences Symposium “The Quest for a COVID-19 Vaccine”
SOUTH SAN FRANCISCO, California, February 3, 2021 (GLOBE NEWSWIRE) – Vaxart, Inc., (NASDAQ: VXRT), a clinical biotechnology company that develops oral tablet-administered vaccines, today announced preliminary Phase 1 data study of VXA-CoV2-1 showing that its oral candidate vaccine COVID-19 in tablet was generally well tolerated and immunogenic as measured by various markers of immune response to SARS-CoV-2 antigens.
“Our Phase I results highlight the importance of our differentiated vaccine design, as they suggest that VXA-CoV2-1 may have broad activity against existing and future coronavirus strains. These results are timely, as we are seeing the emergence of new variants that are less responsive to first-generation vaccines, making potential cross-reactivity another important advantage of next-generation vaccines, ”said Andrei Floroiu, CEO of Vaxart.
Vaxart scientists recognized early the risk of the emergence of SARS-CoV-2 variants and developed a vaccine with potential protection not only against the prevalent strain, but also against emerging mutations of the Spike (S) protein, including both S Proteins and N. Virtually all other COVID-19 vaccines include only protein S.
“These results, together with recent data from our peers, further increase our confidence in the success of VXA-CoV2-1 and the broad potential of our platform,” continued Floroiu.
“We showed earlier that our oral tablet vaccine technology worked to protect against influenza – another airborne virus – as well as the leading injectable, but by a different mechanism, in a Phase II trial sponsored by BARDA. With COVID-19, we have now seen that many vaccine approaches – mRNA, protein and viral vector, including three adenovirus vaccines – are protective, and that all available positive COVID-19 hamster challenge studies, like ours, have translated in protection against COVID -19 in human testing, ”said Floroiu.
“This clinical data further differentiates our COVID-19 vaccine and allows us to significantly advance discussions with health officials in the US and around the world about how Vaxart can help them fight COVID-19 with a transformative solution – a sala – temperature-stable oral vaccine that is not only easier to distribute and administer, but can also be more widely protective, ”added Floroiu.
Sean Tucker, Ph.D., Vaxart’s Scientific Director, will present the Phase 1 data as part of a clinical trial update at the New York Academy of Sciences Symposium “The Quest for a COVID-19 Vaccine” today at 1:15 pm ET . Register here to participate in the symposium.
Preliminary results from the Phase 1 trial of a joint analysis of all cohorts include:
VXA-CoV2-1 was generally well tolerated:
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No serious adverse events have been reported
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Adverse events were generally mild and mainly gastrointestinal in nature
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Including this study, a total of 495 individuals were dosed with our platform, with no serious adverse events reported
VXA-CoV2-1 elicited multiple immune responses against SARS-CoV-2 antigens, including:
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CD8+ Cytotoxic T cell response to viral Spike (S) protein, required for long-lasting cross-reaction immunity, greater than we have seen in any previous Vaxart clinical trial
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An increase in the number of plasmoblastic cells and a positive regulation of the mucosal homing receptor, indicating the activation of B cells that will host in the mucosa
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An increase in pro-inflammatory Th1 cytokines, responsible for orchestrating the immune response to viral infection
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IgA responses in serum samples and / or nasal smears in 100% of individuals with 2 doses; neutralizing antibodies were not detected in the serum and IgG responses were not detected in most subjects
“Viral variants with altered S proteins are establishing themselves in the population before most people can be vaccinated. To end the pandemic, the world needs a vaccine that can provide lasting protection against emerging strains, ”said Dr. Tucker.
“T cells can provide long-term cross-reactive protection against current and emerging strains of the virus. Our vaccine induced a high percentage of CD8 response+ T cells against the proteins Spike (S) and Nucleoproteína (N), that can provide protection against variants with changes in the protein of faster change. We hope that our vaccine will be less affected by new variants than injectable vaccines, ”added Dr. Tucker.
Vaxart hopes to expand its development plans for the COVID-19 vaccine, with efforts that may include:
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VXA-CoV2-1 in COVID-19 virgin individuals: phase II studies to assess the optimal dosing schedule and then assess effectiveness against COVID-19
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VXA-CoV2-1 in previously vaccinated or exposed individuals: investigating a single dose booster protocol to expand and strengthen immune responses
Clinical trial design
The Phase I study (NCT04563702) was designed to assess the safety and immunogenicity of the VXA-CoV2-1 vaccine with multiple dosing schedules. The individuals were divided into three cohorts. The first cohort (5 subjects) received two low doses of the vaccine 29 days apart. The remaining cohorts (15 subjects each) received a single low or high dose of the vaccine. Safety and tolerability were monitored after vaccination, as well as signs of immunogenicity, including general and specific immune responses to SARs-CoV-2.
About Vaxart
Vaxart is a clinical biotechnology company that develops a variety of oral recombinant vaccines based on its proprietary distribution platform. Vaxart vaccines are designed to be administered in tablets that can be stored and shipped without refrigeration and eliminate the risk of needle stick injuries. Vaxart believes its proprietary tablet vaccine delivery platform is suitable for delivering recombinant vaccines, positioning the company to develop oral versions of vaccines currently on the market 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-oncological indication. Vaxart has filed a large deposit of national and international patents covering its technology and proprietary creations for oral vaccination using adenovirus and TLR3 agonists.
Note on forward-looking statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, except statements of historical facts, included in this press release about Vaxart’s strategy, perspectives, plans and objectives, results of preclinical and clinical studies, marketing agreements and licenses, management’s beliefs and expectations are statements prospective. These forward-looking statements may be accompanied by words such as “should”, “believe”, “could”, “potential”, “will”, “expected”, “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements related to Vaxart’s ability to develop (including enrolling a sufficient number of individuals and manufacturing sufficient quantities of its candidate products) and marketing its candidate vaccine COVID-19 and pre-clinical or clinical results and trial data (including plans for candidate vaccines COVID-19); expectations regarding the timing and nature of future announcements, including those related to clinical trials and results of pre-clinical studies; Vaxart’s expectations regarding the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for coronavirus; the potential applicability of the results observed in our studies or pre-clinical trials to those that can be observed in human or clinical studies; the expected role of mucosal immunity in blocking COVID-19 transmission; and Vaxart’s expectations regarding 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 may differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Several important factors may 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 outcomes, start and / or completion dates for clinical trials or pre-clinical studies, regulatory submission dates, regulatory approval dates and / or launch dates, as well as the possibility of unfavorable new clinical data and additional analysis of existing clinical data; the risk that data from clinical and pre-clinical studies are subject to different interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design and results of clinical studies; decisions by regulatory authorities that affect the labeling, manufacturing processes and safety that may affect the availability or commercial potential of any candidate product, including the possibility that Vaxart candidate products will not be approved by the FDA or non-US regulatory authorities ; that, even if approved by the FDA or non-US regulatory authorities, Vaxart’s candidate products may not gain wide acceptance in the market; that a Vaxart employee cannot reach development and commercial milestones; that Vaxart or its partners may experience manufacturing problems and delays due to events within or outside the control of Vaxart or its partners, including the recent outbreak of COVID-19; difficulties in production, particularly in increasing initial production, including difficulties with production costs and yields, quality control, including stability of the candidate product and quality assurance tests, shortage of qualified personnel or essential raw materials and compliance with standards strictly enforced federal and state laws, and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce the necessary patent and other intellectual property protections; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to raise sufficient capital to finance its operations on terms acceptable to Vaxart, if any; the impact of government health 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 assumes no obligation to update any forward-looking statements, except as required by law.
Contacts:
relationship with investors
David R. Holmes
LifeSci Advisors, LLC
Tel: (646) 970-4995
[email protected]
Media relations
Gloria Gasaatura
LifeSci Communications
Tel: (646) 970-4688
[email protected]
Originally published