SOUTH SAN FRANCISCO, Calif., April 30, 2020 (GLOBE NEWSWIRE) -- Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that it has obtained positive pre-clinical results for its COVID-19 vaccine candidates, with several of the vaccine candidates generating immune responses in all tested animals after a single dose.
“These pre-clinical results confirm that all constructs are immunogenic as measured by IgG antibodies in serum, and we observed a robust boosting effect after the second dose.” said Sean Tucker, Ph.D., chief scientific officer of Vaxart. “This latest data set will help to select the lead candidate for manufacturing, and we remain on track to start a first phase 1 study in the second half of this year.”
In January 2020, Vaxart initiated a program to develop a COVID-19 vaccine based on its VAASTTM oral vaccines platform. The Company is currently evaluating multiple vaccine candidates in its preclinical models. In this second round of preclinical testing, all animals received two doses of the Vaxart vaccines, two weeks apart. Antibody responses in all vaccinated groups were statistically significant compared to the untreated controls. Vaxart plans to select one or more vaccine candidates for cGMP manufacturing and clinical testing based on the magnitude and the breadth of the immune response.
“Our oral vaccines have been shown to protect against respiratory infection based on mucosal immunity, the first line of defense for such infections, as recently published in the Lancet Infectious Diseases,” said Wouter Latour, MD, chief executive officer of Vaxart Inc. “This could be important for an effective vaccine that protects the global population from COVID-19. In addition, the Vaxart vaccine would be administered orally using a room temperature-stable tablet, an enormous logistical advantage over injectables in large vaccination campaigns.”
Vaxart is a clinical-stage biotechnology company primarily focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform. Vaxart’s vaccines are designed to generate broad and durable immune responses that protect against a wide range of infectious diseases and may also be useful for the treatment of chronic viral infections and cancer. Vaxart’s vaccines are administered using a convenient room temperature-stable tablet, rather than by injection. Vaxart believes that tablet vaccines are easier to distribute and administer than injectable vaccines and have the potential to significantly increase vaccination rates. Vaxart’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (“RSV”), as well as a therapeutic vaccine for human papillomavirus (“HPV”). For more information, please visit www.vaxart.com.
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 pre-clinical and clinical trials, commercialization agreements and licenses, 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,” “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 and clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations relating to Vaxart’s relationship with Emergent, including Emergent’s ability to produce bulk cGMP vaccine and the timing thereof; and Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for mucosal pathogens such as norovirus, flu and RSV, as well as coronaviruses such as SARS, MERS and SARS CoV-2. 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 may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s control, including the recent outbreak of COVID-19; 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.
“In January we pivoted to COVID-19, and we are now on track to start a first Phase 1 study in the second half of this year with our oral tablet vaccine,” said Wouter Latour, MD, chief executive officer of Vaxart. “We are developing a state-of-the-art gene-based vaccine utilizing our proprietary...
Conspiracy theorists may suspect that this company is so well ahead in the field of immunisation that there are suspicions of complicity.
A natural reaction perhaps when the earnings about to be received will be in the billions.
Candidates: Five vaccines based on proprietary VAAST™ Platform Category: VAX Type: Oral recombinant vaccines administered by room temperature-stable tablet Status: Vaxart on April 30 said it obtained positive preclinical results for its COVID-19 vaccine candidates, with “several” of the candidates generating immune responses in all tested animals after a single dose. “These preclinical results confirm that all constructs are immunogenic as measured by IgG antibodies in serum, and we observed a robust boosting effect after the second dose,” Vaxart Chief Scientific Officer Sean Tucker, PhD, stated.
Tucker said Vaxart will use the data to select a lead candidate for manufacturing: “We remain on track to start a first phase 1 study in the second half of this year.”
Earlier in April, Vaxart reported positive preclinical results for its five COVID-19 vaccine candidates, saying that several of them generated immune responses in all tested animals after a single dose. Additional data will determine which of the candidates Vaxart advances into clinical trials, Chief Scientific Officer Sean Tucker, PhD, stated, adding: “We are particularly interested in vaccine candidates that can generate mucosal immune responses in addition to serum antibody responses.”
In March, Vaxart disclosed it had produced five COVID-19 vaccine candidates for testing in preclinical models. Each vaccine construct is based on a different coronavirus antigen combination, Vaxart said, adding that it expects to advance the best performing vaccine to manufacturing for clinical trials.
Vaxart has agreed to use the “molecule-to-market” contract development and manufacturing (CDMO) services of Emergent BioSolutions in preparation for cGMP production of a vaccine. Provided Vaxart elects to proceed with cGMP manufacturing, Emergent is expected to produce bulk cGMP vaccine for use in a Phase I study that Vaxart said could be launched in the second half of 2020. Vaxart also said it was prioritizing development of the COVID-19 vaccine by putting several vaccine programs on hold, including its therapeutic HPV vaccine program and a norovirus vaccine program for which the company completed a successful Phase I study, and was actively seeking a development partner.
Emergent has said it will provide development services out of its Gaithersburg, MD location and manufacture drug substance at its Bayview facility in Baltimore, designated a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services.
Vaxart disclosed plans in January to generate vaccine candidates based on the published genome of SARS-CoV-2, and evaluate them in preclinical models based on their ability to generate both mucosal and systemic immune responses. The company cited a study published in TheLancet Infectious Diseases, showing that the Vaxart oral H1 influenza tablet vaccine primarily protected against infection based on mucosal immunity, compared with the injectable flu vaccine that protected primarily through systemic immunity. COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
Candidate: VXA-CoV2-1 Category: VAX Type: Oral recombinant vaccine administered by room temperature-stable tablet, and based on proprietary VAAST™ Platform. The vaccine is designed to target both the spike protein (S) and nucleoprotein (N). 2021 Status: Vaxart said February 25 that it will...