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Vaxart Reports Positive Clinical Data Demonstrating that its Second-Generation Vaccine Technology Produces Much Stronger Antibody Responses than its First-Generation Technology
- Second-generation norovirus constructs produce statistically significant increases in GI.1 and GII.4 norovirus blocking antibodies (141% and 94%, respectively) compared with first-generation constructs, supporting potential for improved protection against infection -
- Vaccine candidates were safe and well-tolerated across all dose groups with no vaccine-related serious adverse events reported -
- Conference call today at 8:30 a.m. ET -
SOUTH SAN FRANCISCO, Calif., June 11, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT), a clinical-stage biotechnology company developing a range of oral recombinant pill vaccines based on its proprietary delivery platform, today reported positive topline results from the Phase 1 clinical trial evaluating its second-generation oral pill norovirus vaccine constructs head-to-head against its first-generation constructs.
The open-label, Phase 1 trial was conducted in 60 healthy volunteers who were randomized to receive the first-generation constructs, an equivalent dose of the second-generation GI.1 and GII.4 constructs, or a lower dose of the second-generation constructs (n=20 for each group). The primary immunological endpoint was norovirus blocking antibody assay (NBAA) titer at Day 0 and Day 28. In a Phase 2 challenge trial of the first-generation vaccine constructs, these functional NBAA titers correlated with protection against norovirus infection. Although the study was not powered to determine superiority by statistical methods, the increase in NBAA titers with the second-generation constructs was sufficiently large (141% for the GI.1 construct and 94% for the GII.4 construct) to demonstrate statistical significance at the higher dose.
“Consistent with what we previously demonstrated in animal models, these clinical data prove that our second-generation constructs increased antibody titers in humans, providing additional compelling evidence of the potential of our oral pill vaccine candidates,” said Sean Tucker, PhD, Vaxart’s Founder and Chief Scientific Officer. “We previously demonstrated that our first-generation construct for the norovirus GI.1 genotype protected against infection and that protection correlated with increased antibody levels detected by our proprietary NBAA assay. The significant increases in NBAA titers reported today give us high confidence that our second-generation constructs will provide even greater protection against infection.”
Key findings from the study show:
Significantly increased GI.1 NBAA titers in the cohort receiving the high dose of the second-generation constructs compared with an equivalent dose of the first-generation constructs. A 141% increase in GI.1 NBAA titers was observed, which corresponds to a 3.2 increase in Geometric Fold Response (GMFR) from 2.2 to 5.4.
Significantly increased GII.4 NBAA titers in the cohort receiving the high dose of the second-generation constructs compared with an equivalent dose of the first-generation constructs. A 94% increase in NBAA titers was observed, which corresponds to a 1.8 increase in GMFR from 1.9 to 3.7.
The low dose of the second-generation constructs produced a numerical increase in NBAA titers compared with the first-generation constructs. 129% increase in NBAA titers for GI.1 was observed, which corresponds to a 2.9 increase in GMFR from 2.2 to 5.1.84% increase in NBAA titers for GII.4 was observed, which corresponds to a 1.6 increase in GMFR from 1.9 to 3.5.
With respect to safety, all norovirus vaccine candidates evaluated in this study were well-tolerated, with no vaccine-related serious adverse events.
Vaxart intends to publish the complete results of this study in a peer-reviewed journal.
“We are very pleased with these results, which exceeded our expectations. With no currently approved vaccine, norovirus causes millions of infections globally resulting in billions of dollars of economic burden,” said Steven Lo, Chief Executive Officer of Vaxart. “We believe that our second-generation norovirus oral pill vaccine candidate has the potential to provide first-in-class or best-in-class protection against this highly contagious virus where there is significant unmet need. We intend to incorporate these compelling new data into our ongoing discussions with potential partners.”
Assuming a partnership or other funding, Vaxart expects to conduct a Phase 2b safety and immunogenicity study that could potentially begin as early as the second half of 2025 followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026.
Vaxart’s oral pill technology works by inducing expression of antigen proteins in the cells of humans’ intestines. Vaxart’s second-generation technology was developed in 2023 and 2024 to achieve two purposes: first, to increase expression levels of the antigen proteins, and thus to greatly increase antibody titers; and second, to improve manufacturability. In pre-clinical experiments, the second-generation constructs substantially improved antibody responses in animal models. The trial reported today, for the updated norovirus vaccine candidate, is the first test in humans of the new technology. Vaxart has also adopted the new technology in its latest COVID-19 vaccine candidate and implemented these improvements throughout its portfolio.
There is no approved vaccine against norovirus, a leading cause of acute gastroenteritis (AGE) worldwide that is responsible for outbreaks of infection and illness globally. Each year there are approximately 685 million norovirus infections globally, with 20 million infections occurring annually in the United States. Due to these high rates of infection, norovirus is believed to cause nearly 20% of diarrheal disease globally. Additionally, the economic burden associated with norovirus infection and AGE is estimated at $60 billion worldwide and $10 billion in the United States.
Conference Call
The Vaxart senior management team will host a conference call to discuss the topline data from the norovirus Phase I trial today, beginning at 8:30 a.m. ET.
The conference call can be accessed using the following information:
Webcast: Click here
Date: Wednesday, June 11, 2025 – 8:30 a.m. ET
Domestic: (877) 407-0832
International: (201) 689-8433
Conference ID: 13754315
Investors may submit written questions in advance of the conference call to ir@vaxart.com.
A replay of the webcast will be available on the Company’s website at www.vaxart.com following the conclusion of the event.
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 and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applicati
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2年前
Vaxart Receives BARDA-Funded Project NextGen Award Valued Up to $453 Million to Conduct a Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate
June 13 2024 - 4:15PM
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Vaxart, Inc. (Nasdaq: VXRT) announced today that it received a project award valued at up to $453 million through the Rapid Response Partnership Vehicle (RRPV). The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).
The funds will be used to conduct a Phase 2b comparative study evaluating Vaxart’s oral pill COVID-19 vaccine candidate against a U.S. Food and Drug Administration (FDA)-approved mRNA vaccine comparator. In preparation for the trial, Vaxart created and manufactured under Good Manufacturing Practice (GMP) standards a next-generation oral COVID-19 vaccine tablet candidate that — based on preclinical data — is more potent than Vaxart’s prior COVID-19 vaccine constructs.
Funding under the award will be provided in two parts with approximately $65.7 million available immediately to continue study start-up activities, and the remainder of approximately $387.2 million provided when Vaxart and BARDA have determined that the study may further proceed and paid over the course of the study. Currently, Vaxart anticipates initiating enrollment as early as summer 2024. An interim analysis for vaccine efficacy compared to an approved mRNA comparator may occur as early as the first quarter of 2025.
“We are grateful to BARDA for this funding, which will enable Vaxart to conduct a Phase 2b trial for our COVID-19 oral pill vaccine candidate. This trial will evaluate whether our oral pill vaccine candidate compares favorably against an approved mRNA injectable vaccine,” said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “We are excited to explore the results of this head-to-head comparison. Previous research showed that our earlier COVID-19 vaccine constructs triggered long-lasting immune responses and induced a cross-reactive immunogenic response against all tested SARS-CoV-2 variants.”
“Vaccine delivery has relied primarily on injection for more than 150 years. This funding from BARDA will assist us in determining whether we can bring a transformational, next-generation approach to global vaccination,” said Steven Lo, Vaxart’s Chief Executive Officer. “We believe our oral pill vaccine platform can better meet societal needs not just for COVID-19, which is now in the endemic phase, but for other infectious diseases that present significant endemic and pandemic threats.”
Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19. In earlier clinical trials, Vaxart demonstrated its COVID-19 vaccine candidates generated robust cross-reactive mucosal IgA responses, boosted immune responses to existing COVID-19 vaccines, increased neutralizing antibodies against Omicron 4/5, and had a benign tolerability profile.
Funding for this award was received under Project NextGen, a $5 billion initiative by HHS to develop new, innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19 than the first generation COVID-19 vaccines and medicines. This project has been funded with federal funds from HHS; ASPR; BARDA, under Other Transaction (OT) number 75A50123D00005.
About the COVID-19 Phase 2b Trial
The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The study design anticipates enrolling approximately 10,000 healthy adults 18 years and older in the United States with 5,000 receiving Vaxart’s COVID-19 vaccine candidate and 5,000 receiving an approved mRNA comparator. At least 25% of the participants should be at least 65 years old.
The study will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events. The primary endpoint is relative efficacy of Vaxart’s COVID-19 vaccine candidate compared to an approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.
An independent Data and Safety Monitoring Board (DSMB) will review safety data of the participants.
Execution of this Phase 2b study will be funded by BARDA through the RRPV.
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 and influenza, 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, receipt of funding from BARDA for the Phase 2b study, results from preclinical and clinical trials and the timing of such trials and results, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words
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