Vaxart Gets BARDA Nod to Start Dosing in 10,000-Participant Phase 2b COVID-19 Trial

Vaxart, Inc., a biotechnology firm located in South San Francisco, has announced a significant development in its efforts to combat COVID-19. The company has received approval from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to commence dosing in the large-scale segment of its Phase 2b clinical trial. This trial will involve 10,000 participants and aims to test the efficacy of Vaxart's oral COVID-19 vaccine candidate. The first patient in this part of the study is expected to be dosed in the second quarter of 2025.

Steven Lo, the Chief Executive Officer of Vaxart, expressed his appreciation for the support received from HHS and BARDA. He emphasized the importance of this collaboration in advancing the clinical development of the company's vaccine candidate. The Phase 2b trial is designed as a double-blind, multi-center, randomized study, comparing Vaxart's oral vaccine candidate against an approved mRNA COVID-19 vaccine. The trial will focus on adults who have already been vaccinated against COVID-19, assessing the relative efficacy, safety, and immunogenicity of the oral vaccine.

This initiative is part of Project NextGen, a $5 billion program led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID). The project aims to accelerate the development of novel COVID-19 vaccines, therapeutics, and related technologies. Vaxart's involvement in this program includes a project award valued at up to $460.7 million through the Rapid Response Partnership Vehicle Consortium. The funding for this project has been allocated under Other Transaction number 75A50123D00005, with contributions from HHS, ASPR, and BARDA.

Vaxart specializes in developing oral recombinant vaccines using its proprietary delivery platform. These vaccines are designed to be administered as pills, which can be stored and transported without the need for refrigeration, eliminating the risk associated with needle-stick injuries. The company is working on developing oral versions of currently marketed vaccines as well as designing new vaccines for various indications. Vaxart's current development pipeline includes pill vaccines targeting coronavirus, norovirus, and influenza, alongside a therapeutic vaccine for human papillomavirus (HPV), marking its first venture into immune-oncology.

Vaxart has filed comprehensive domestic and international patent applications to protect its proprietary technology and innovations in oral vaccination, focusing on the use of adenovirus and TLR3 agonists. The company's pill vaccine platform is seen as a promising alternative to traditional vaccination methods, offering potential benefits in terms of ease of administration and distribution.

Overall, Vaxart's progress in developing an oral COVID-19 vaccine candidate represents a significant step forward in the global effort to enhance vaccine accessibility and effectiveness. The support from BARDA and the involvement in Project NextGen underscore the importance of innovative approaches in addressing the ongoing challenges posed by the COVID-19 pandemic. As the company moves forward with its clinical trials, it continues to explore new opportunities for its vaccine technology in various therapeutic areas.