VXA

Vaxart Announces Positive Top-line Phase II Clinical Study Data Demonstrating Safety and Immunogenicity of Its Wuhan S-Only COVID-19 Pill Vaccine Candidate

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Thursday, September 1, 2022
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SOUTH SAN FRANCISCO, Calif., Sept. 01, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today reported positive top-line data from the first part of a planned two-part Phase II study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S. The data demonstrate that the trial met its primary safety and secondary immunogenicity endpoints and will inform ongoing development of new Omicron-based vaccine constructs.

Key Points: 
  • ET today
    SOUTH SAN FRANCISCO, Calif., Sept. 01, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today reported positive top-line data from the first part of a planned two-part Phase II study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S.
  • Vaxart is the first company to advance an oral pill COVID-19 vaccine to Phase II clinical development.
  • These Phase II data represent a very important milestone in the development of the worlds first COVID-19 pill vaccine, said Dr. James F. Cummings, Vaxarts Chief Medical Officer.
  • These data also demonstrate that a pill vaccine can induce strong serum antibody responses as well as mucosal and T cell responses.

New Preclinical Data Demonstrate Two of Vaxart’s COVID-19 Vaccine Candidates Protect Against Omicron

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Friday, June 3, 2022
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SOUTH SAN FRANCISCO, Calif., June 03, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today reported positive preliminary preclinical data demonstrating that two COVID-19 vaccine candidates targeting either the SARS-CoV-2 spike (S) protein for Wuhan or S protein for Omicron protected hamsters when challenged with the Omicron BA.1 variant.

Key Points: 
  • A broadly cross-reactive vaccine may be the most effective way to protect against current and future variants, said Dr. Sean Tucker, Vaxarts SVP and Chief Scientific Officer.
  • We developed an Omicron specific vaccine candidate and compared it with our original Wuhan strain vaccine candidate that is currently in Phase II clinical trials.
  • The data reported today are from a study in which the S-only Wuhan and Omicron vaccine candidates were compared in a hamster challenge model.
  • Both vaccines produced antibody responses to the S protein of Omicron, with the Omicron candidate slightly better at making serum IgG antibodies to the matched protein
    These findings demonstrate that in this preclinical model both vaccine candidates protect against the Omicron variant.

Vaxart Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results

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Thursday, February 24, 2022
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SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) issued its business update today for the fourth quarter and full year 2021, reporting forward momentum for the Company, including its oral norovirus and COVID-19 vaccine candidates.

Key Points: 
  • During the fourth quarter of 2021, Vaxart began Phase II clinical trials of its oral tablet COVID-19 vaccine in the U.S. Vaxart dosed its first subject in late October 2021.
  • The Companyreported a net loss of$20.8 millionfor the fourth quarter of 2021, compared to$13.9 millionfor the fourth quarter of 2020.
  • Research and development expenses were$15.5 millionfor the fourth quarter of 2021, compared to$8.6 millionfor the fourth quarter of 2020.
  • General and administrative expenses were$5.8 millionfor the fourth quarter of 2021, compared to$5.1 millionfor the fourth quarter of 2020.

Vaxart’s S-Only COVID-19 Vaccine Candidate Produces Strong-Cross Reactive Mucosal and Systemic Immune Responses in Non-Human Primates

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Thursday, February 24, 2022
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SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- A new study published on BioRxiv.org demonstrates that Vaxart’s S-only COVID-19 clinical vaccine candidate, now being studied by Vaxart in Phase II trials, generated antibodies to the original COVID-19 virus strain and to the beta, delta, alpha and gamma variants of SARS-CoV-2 in the serum and nasal mucosa of non-human primates (NHPs).

Key Points: 
  • Each candidate was administered intranasally to four animals 28 days apart; four other animals received an S protein vaccine via intramuscular injection followed by intranasal administration of ED88.
  • Key findings from the study include:
    Mucosal administration generated levels of IgG that were similar to data reported for other SARS-CoV-2 vaccines.
  • Vaxarts S-only vaccine, clinical candidate VXA-CoV2-1.1-S, induced the most potent antibody response of the three candidates tested, generating substantial nasal IgA and serum IgG to multiple variants.
  • Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Vaxart to Test Cross-Reactivity of its COVID-19 Oral Tablet Vaccine Against Omicron

Retrieved on: 
Thursday, December 16, 2021
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SOUTH SAN FRANCISCO, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) said today it plans to test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron SARS-CoV-2 variant in two different studies expected to begin next month.

Key Points: 
  • In the first study, Vaxart will test the activity of its Phase II COVID-19 oral vaccine candidate against Omicron by analyzing mucosal and serum samples from subjects to whom the vaccine was administered in Vaxarts current COVID-19 vaccine Phase II trials, Dr. Sean Tucker, Vaxarts Chief Scientific Officer and founder, said.
  • In May 2021, the Company announced Phase I clinical test results demonstrating that its vaccine candidate, VXA-CoV2-1, produced broad cross-reactive T cell and IgA responses against other, non-COVID coronaviruses.
  • Dr. Tucker also said that results from Vaxarts Phase I clinical testing and earlier preclinical testing support Vaxarts belief that its vaccine candidates should be reactive against Omicron.
  • As a result, we expect that this vaccine candidate should also be able to respond to the Omicron variant.

Stanford Scientists First To Identify New Cellular Correlates of Protection Against Influenza for an Oral Flu Vaccine Developed by Vaxart

Retrieved on: 
Thursday, November 18, 2021
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Results of the Phase II study were the first to show that VXA-A1.1 offered greater protection against viral shedding than the injected IIV.

Key Points: 
  • Results of the Phase II study were the first to show that VXA-A1.1 offered greater protection against viral shedding than the injected IIV.
  • Random forest-based machine learning models were used to define high-dimensional cellular correlates between the immune profiling and viral shedding data.
  • Human influenza virus challenge identifies cellular correlates of protection for oral vaccination.
  • Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study.

Vaxart Provides Business Update and Reports Third Quarter 2021 Financial Results

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Thursday, November 4, 2021
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SOUTH SAN FRANCISCO, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) issued its business update today for the third quarter of 2021, reporting strong forward momentum in developing its oral vaccine platform consisting of tablet vaccines that it believes may revolutionize public health.

Key Points: 
  • Financial Results for the Three Months EndedSeptember 30, 2021
    Vaxartended the quarter with cash, cash equivalents and available-for-sale debt securities of$204.0 million, compared to$198.9 million as ofJune 30, 2021.
  • The Companyreported a net loss of$17.6 millionfor the third quarter of 2021, compared to$8.1 millionfor the third quarter of 2020.
  • Research and development expenses were$12.4 millionfor the third quarter of 2021, compared to$4.6 millionfor the third quarter of 2020.
  • General and administrative expenses were$5.0 millionfor the third quarter of 2021, compared to$4.2 millionfor the third quarter of 2020.

StrikeReady Recognized as a Technology Innovator for Advanced Virtual Assistants in 2021 Gartner® report

Retrieved on: 
Thursday, November 4, 2021
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StrikeReady , a cloud-based security operations and management company, announced today that it was named a Technology Innovator in Advance VAs by 2021 Gartner Emerging Technologies: Tech Innovators in Advanced Virtual Assistants report.

Key Points: 
  • StrikeReady , a cloud-based security operations and management company, announced today that it was named a Technology Innovator in Advance VAs by 2021 Gartner Emerging Technologies: Tech Innovators in Advanced Virtual Assistants report.
  • According to Gartner, this report highlights technology providers that advance and accelerate the use of virtual assistant technology.
  • The time has come for these security teams to leverage AI-powered cyber virtual assistants, think of highly skilled domain-centric Siri and/or Cortana," said Yasir Khalid, CEO of StrikeReady.
  • *Gartner, Emerging Technologies: Tech Innovators in Advanced Virtual Assistants, Annette Jump , Danielle Casey , Adrian Lee , September 22, 2021.

Vaxart Announces Positive Preliminary Data from Phase 1 Clinical Trial Evaluating Its Oral COVID-19 Tablet Vaccine Candidate

Retrieved on: 
Wednesday, February 3, 2021
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Our Phase I results highlight the importance of our differentiated vaccine design, as they suggest VXA-CoV2-1 could have broad activity against existing and future coronavirus strains.

Key Points: 
  • Our Phase I results highlight the importance of our differentiated vaccine design, as they suggest VXA-CoV2-1 could have broad activity against existing and future coronavirus strains.
  • These results, together with recent data from our peers, further raise our confidence in the success of VXA-CoV2-1 and the broad potential of our platform, continued Floroiu.
  • We previously showed that our oral tablet vaccine technology worked to protect against flu another airborne virus as well as the leading injectable, but through a different mechanism, in a Phase II trial sponsored by BARDA .
  • Sean Tucker, Ph.D., Vaxarts Chief Scientific Officer, 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 p.m.

Vaxart Announces Dosing First Subject in Phase 1 Clinical Trial of Its Oral Tablet COVID-19 Vaccine

Retrieved on: 
Tuesday, October 13, 2020
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We are eager to explore the clinical profile of VXA-CoV2-1 for effective protection against SARS-CoV-2 infection and transmission in healthy adults.

Key Points: 
  • We are eager to explore the clinical profile of VXA-CoV2-1 for effective protection against SARS-CoV-2 infection and transmission in healthy adults.
  • Enrollment is expected to be completed by early November 2020, with participants receiving the low or high dose of the VXA-CoV2-1 oral tablet at days 1 and 29.
  • Safety, reactogenicity and immunogenicity assessments will be performed at set times during the active phase.
  • We are very excited about our oral tablet vaccine entering the clinic because we believe that the COVID-19 pandemic needs an oral alternative to injectable vaccines, said Andrei Floroiu, chief executive officer ofVaxart.