Vaxart (NASDAQ: VXRT) stock surged during pre-market trading Friday after the biotechnology company received major funding for an oral COVID-19 vaccine trial.
Vaxart has secured up to $453 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to conduct a comparative study of its oral COVID-19 vaccine candidate against an FDA-approved mRNA vaccine.
Funding Details
The funding will primarily support a Phase 2b clinical trial. The company expects to commence enrollment for the trial by the summer of 2024.
BARDA will fund the Phase 2b trial in stages, allocating approximately $65.7 million immediately for initial study activities, with the release of the remaining funds contingent upon meeting specific milestones.
Study Details
The study will enroll around 10,000 adults in the U.S., with a minimum of 25% of the participants aged 65 years or older. The trial will evaluate the vaccine’s effectiveness in preventing symptomatic COVID-19 infections and asymptomatic COVID-19 infections and determine its safety profile.
Vaxart’s oral vaccine tablet, produced under Good Manufacturing Practice (GMP) standards, has demonstrated enhanced potency in preclinical studies compared to earlier vaccine versions. The tablet form of the vaccine offers significant logistical advantages, such as ease of administration, the elimination of needle-stick injuries, and the ability to be stored and shipped without refrigeration.
Dr. James F. Cummings, the Chief Medical Officer of Vaxart, expressed gratitude for the BARDA funding, emphasizing the importance of the upcoming trial. He stated,
“We are grateful to BARDA for this funding, enabling 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.”
Cummings highlighted previous research indicating that Vaxart’s earlier COVID-19 vaccine constructs elicited durable immune responses and cross-reactive immunity against various SARS-CoV-2 variants.
The Phase 2b study will include a head-to-head comparison of the oral vaccine with the mRNA comparator, with primary analysis scheduled 12 months post-vaccination. An independent Data and Safety Monitoring Board (DSMB) will oversee participant safety throughout the trial.
This initiative is part of Project NextGen, a $5 billion effort by the U.S. Department of Health and Human Services to accelerate the development of new COVID-19 vaccines and treatments.
Vaxart (NASDAQ: VXRT) has previously completed a Phase 2 trial for an oral vaccine and is advancing developments for norovirus and influenza vaccines.
Vaxart (NASDAQ: VXRT) Stock Movement
As of 05:30 a.m. (Eastern Time) Friday, VXRT stock traded at $0.9936, marking a 32.49% increase compared to the previous trading session.
