Vaxart, Inc. (Nasdaq: VXRT) has announced key advancements in its oral vaccine programs targeting COVID-19, norovirus, and influenza. The company is progressing towards significant milestones with its proprietary oral pill vaccine platform.
COVID-19 Vaccine Program Update
The Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate is poised to initiate the 10,000-participant portion of the trial, pending a favorable review of the 30-day safety data from the sentinel cohort by the U.S. Food and Drug Administration (FDA) and approval from the Biomedical Advanced Research and Development Authority (BARDA). An independent Data and Safety Monitoring Board (DSMB) has already recommended the continuation of the Phase 2b study after reviewing the sentinel cohort's safety data, which compares Vaxart’s oral vaccine against an approved mRNA vaccine.
The primary efficacy analysis will be conducted after all participants have either completed or discontinued a study visit 12 months post-vaccination. This project is supported by funding received under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID). Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $460.7 million.
Steven Lo, Vaxart’s Chief Executive Officer, stated, “We believe that the favorable review of the 30-day sentinel cohort safety data of our Phase 2b trial by an independent DSMB has us well-positioned to initiate the 10,000-participant portion of the trial following a positive review from the FDA as well as approval from BARDA to proceed.”
Norovirus Vaccine Program Update
Vaxart is set to proceed with a Phase 1, open-label, dose-ranging clinical trial to evaluate its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. The trial will assess safety and immune parameters correlated with protection observed in a completed norovirus challenge study. The Phase 1 trial is expected to commence in the first half of 2025, with topline data anticipated as early as mid-2025.
James F. Cummings, MD, Vaxart’s Chief Medical Officer, noted, “Our second-generation constructs induced stronger immune responses in preclinical models. As a result, our next clinical study will evaluate these next generation constructs head-to-head against our first-generation constructs to verify this robust response.”
If the Phase 1 trial yields positive results, a Phase 2 safety and immunogenicity study could potentially begin as early as the second half of 2025, followed by an End of Phase 2 meeting with the FDA. A Phase 3 trial could then commence as early as 2026, contingent on partnership or additional funding.
Influenza Vaccine Program Update
Vaxart is also advancing its avian influenza program. The company previously published data demonstrating protection in a preclinical model against avian influenza following oral immunization (Clin Vaccine Immunol 2013). Vaxart has developed a new avian influenza vaccine candidate to cover the latest clade 2.3.4.4b and is currently conducting preclinical studies to evaluate the new construct, preparing for potential clinical use. The results of these preclinical studies will be published upon completion.
Financial Outlook
Vaxart anticipates that fees and reimbursements under its Project NextGen award, combined with existing cash, cash equivalents, and investments, will provide the company with a cash runway into 2026, supporting multiple key clinical and regulatory milestones. The company is also exploring business development partnerships and non-dilutive funding options to extend its cash runway further.
