Vaxart Announces Favorable DSMB Review of Sentinel Cohort from COVID-19 Phase 2b Clinical Trial

Clinical Trial Progress - Vaxart's Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to evaluate the efficacy, safety, and immunogenicity of its oral pill COVID-19 vaccine candidate compared to an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 [1] - The company was the first U S company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19 [2] - An independent Data Safety Monitoring Board (DSMB) recommended the study to proceed without modifications based on the initial safety assessment of 400 participants' 30-day data [3] - The company plans to enroll 10,000 participants in the trial, pending favorable review from the FDA and approval from BARDA [3][5] Funding and Support - Vaxart received funding under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate the development of next-generation COVID-19 vaccines, therapeutics, and enablers [4] - The company's project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to$460 7 million, funded by federal funds from the U S Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), and BARDA [4] Company Overview - Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines using its proprietary delivery platform [6] - The company's vaccines are designed to be administered via pills that do not require refrigeration and eliminate the risk of needle-stick injuries [6] - Vaxart's development programs include oral vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [6] - The company has filed broad domestic and international patent applications covering its proprietary technology for oral vaccination using adenovirus and TLR3 agonists [6] Next Steps - The FDA is reviewing the 30-day safety data from the sentinel cohort, and upon favorable review and BARDA approval, the study will progress to enroll approximately 10,000 participants [5] - The trial aims to enroll participants in line with U S demographics, including at least 25% of participants over the age of 65 [5]