Dynavax and Vaxart have entered into a license and collaboration agreement to advance Vaxart’s investigational oral COVID-19 vaccine, with phase 2b data expected in late 2026.
Dynavax Technologies and Vaxart have formed an exclusive global partnership to advance the development and potential commercialization of Vaxart’s investigational oral COVID-19 vaccine, a candidate that uses a novel pill-based delivery platform designed to induce mucosal immunity. The collaboration aligns Dynavax’s strategic focus on expanding its vaccine portfolio with Vaxart’s push to validate its proprietary VAAST oral vaccine technology in a late-stage clinical setting. Unlike traditional injectable COVID-19 vaccines, Vaxart’s oral candidate aims to stimulate immune responses at the mucosal surfaces of the respiratory tract—the primary entry point for SARS-CoV-2.
This needle-free format may improve patient acceptance, reduce transmission, and simplify global distribution by eliminating cold-chain requirements. The vaccine is currently being evaluated in a randomized, double-blind phase 2b trial comparing its efficacy to an FDA-approved mRNA vaccine. Enrollment of approximately 5,400 participants is complete, and topline data are expected in late 2026.
Under the agreement, Dynavax will pay Vaxart a $25 million upfront fee and provide an additional $5 million equity investment. Vaxart will retain responsibility for the program through the phase 2b trial and upcoming end of phase 2 meeting with the FDA. Dynavax will then decide whether to assume clinical development and commercialization. Additional milestone and royalty payments may follow if Dynavax opts in and the program advances.
The deal grants Dynavax exclusive worldwide rights to develop and commercialize Vaxart’s oral COVID-19 vaccine, pending review of phase 2b data.
Vaxart’s oral pill vaccine aims to induce mucosal immunity and improve vaccine accessibility by eliminating needles and cold-chain requirements.
Topline results from the 5,400-participant phase 2b trial are expected in late 2026, after which Dynavax may choose to take over late-stage development.
“The agreement provides us with an exclusive license to a novel program while limiting our overall committed financial obligations. This gives Dynavax the opportunity to evaluate phase 2b data before further committing to invest in late-stage development. This phased approach complements the strong growth trajectory of HEPLISAV-B and aligns with our commitment to building a diversified, sustainable vaccine portfolio,” Dynavax CEO Ryan Spencer, said in a statement.
Under the terms of the license agreement:
“We are excited to partner with Dynavax. This agreement provides a clear and well-funded path forward for our oral vaccine platform in COVID-19,” Vaxart CEO Steven Lo, said in a statement. “Dynavax’s investment and late-stage expertise provide critical support for our technology. We are confident in our ability to complete the ongoing phase 2b trial, and look forward to delivering a robust data package that could unlock the full potential of this collaboration and demonstrate the value of our oral vaccine platform.”
