Vaxart's Phase 2b COVID-19 trial progresses to 10,000 participants after positive safety review by independent DSMB.
Quiver AI Summary
Vaxart, Inc. announced that an independent Data Safety Monitoring Board (DSMB) has recommended continuing its COVID-19 Phase 2b trial without modifications after reviewing safety data from a cohort of 400 participants. The company plans to expand the trial to include 10,000 participants, pending a favorable review from the FDA and approval from the Biomedical Advanced Research and Development Authority (BARDA). This trial aims to compare Vaxart's oral pill COVID-19 vaccine with an approved mRNA vaccine in previously immunized adults. The research is funded under Project NextGen, a $5 billion initiative by BARDA and NIAID to advance innovative COVID-19 therapies and vaccines. Vaxart is recognized as a pioneer in oral vaccines, having completed the first U.S. Phase 2 clinical trial for an oral COVID-19 vaccine.
Potential Positives
- Independent Data Safety Monitoring Board (DSMB) recommended the continuation of the Phase 2b trial without modifications, indicating initial safety data is favorable.
- The company plans to expand the trial to include approximately 10,000 participants, which reflects confidence in the vaccine's safety and the trial's design.
- Funding from BARDA for the project, valued up to $460.7 million, demonstrates significant governmental support and validation for Vaxart's oral vaccine development.
- The trial aims to enroll participants aligned with U.S. demographics, including a substantial number of older adults, enhancing the study's relevance and applicability to the target population.
Potential Negatives
- The company's future success is highly dependent on favorable reviews from both the FDA and BARDA, introducing significant uncertainty regarding the progression of the trial.
- The trial is reliant on achieving enrollment of 10,000 participants, which may pose challenges and risks associated with participant recruitment and demographic alignment.
- Vaxart acknowledges the inherent risks and uncertainties in research and development, indicating potential issues that could arise during the clinical trial phases, which may impact timelines and outcomes.
FAQ
What did the DSMB recommend about Vaxart's trial?
The DSMB recommended proceeding with the trial without modifications after reviewing initial safety data from 400 participants.
How many participants will Vaxart enroll in the trial?
Vaxart plans to enroll approximately 10,000 participants in the Phase 2b trial pending FDA and BARDA approvals.
What is the focus of the Phase 2b trial?
The trial aims to determine the safety, efficacy, and immunogenicity of Vaxart's oral COVID-19 vaccine compared to an mRNA vaccine.
What is Project NextGen?
Project NextGen is a $5 billion initiative to accelerate the development of next-generation COVID-19 vaccines and therapeutics.
How does Vaxart's vaccine delivery platform work?
Vaxart's oral vaccines are designed to be administered using pills that require no refrigeration and eliminate needle-stick injuries.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$VXRT Hedge Fund Activity
We have seen 31 institutional investors add shares of $VXRT stock to their portfolio, and 42 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ALYESKA INVESTMENT GROUP, L.P. removed 1,250,000 shares (-100.0%) from their portfolio in Q3 2024
- SIO CAPITAL MANAGEMENT, LLC removed 1,156,747 shares (-7.8%) from their portfolio in Q3 2024
- SILVERARC CAPITAL MANAGEMENT, LLC added 1,000,000 shares (+inf%) to their portfolio in Q3 2024
- ADAR1 CAPITAL MANAGEMENT, LLC removed 945,568 shares (-100.0%) from their portfolio in Q3 2024
- RENAISSANCE TECHNOLOGIES LLC removed 847,631 shares (-100.0%) from their portfolio in Q3 2024
- MONACO ASSET MANAGEMENT SAM removed 437,366 shares (-72.7%) from their portfolio in Q3 2024
- GEODE CAPITAL MANAGEMENT, LLC added 346,725 shares (+15.8%) to their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Independent Data Safety Monitoring Board (DSMB) recommends study to proceed without modifications based on initial safety assessment of 400 participant 30-day data
The company plans to progress the trial to enrollment of 10,000 participants, upon favorable review from the U.S. Food and Drug Administration (FDA) and upon Biomedical Advanced Research and Development Authority (BARDA) approval
SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that an independent DSMB, which conducted a planned review of the 30-day safety data from a sentinel cohort of 400 participants in its COVID-19 Phase 2b trial, has recommended that the study continue without any modifications.
“We are pleased with the DSMB recommendation, an important step forward in conducting our head-to-head study versus an mRNA comparator,” said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “We look forward to the next steps of review of the safety data by the FDA and approval from BARDA before advancing the Phase 2b trial to the second part that will measure both safety and efficacy.”
The FDA is reviewing the 30-day safety data from the sentinel cohort, and, upon favorable review as well as BARDA’s approval, the study will progress by enrolling approximately 10,000 participants. The trial will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65.
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 compared to an approved mRNA COVID-19 injectable vaccine, in adults previously immunized against COVID-19 infection.
Funding for this award was received under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $460.7 million. This project has been funded with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); BARDA, under Other Transaction (OT) number 75A50123D00005.
As a pioneer of oral vaccines, Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19.
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, results from preclinical and clinical trials and the timing of such results as well as the outcome of the review of such results by regulatory authorities, 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.
Contact
Vaxart Media and Investor Relations
:
Matt Steinberg
FINN Partners
IR@vaxart.com
(646) 871-8481
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
