Dynavax Technologies Corporation, a US-based commercial-stage biopharmaceutical company focused on developing and commercialising innovative vaccines, has entered into an exclusive worldwide license and collaboration agreement with American biotechnology firm Vaxart, which is developing a range of oral recombinant vaccines using its proprietary delivery platform. The partnership centres on Vaxart’s investigational oral COVID-19 vaccine candidate.

Vaxart’s oral vaccine candidate features a novel mechanism of action and delivery method compared with currently available COVID-19 vaccines. Designed to be administered as a pill, the vaccine aims to induce mucosal immunity at respiratory entry points, potentially reducing infection, transmission and disease severity. In addition, the oral vaccine delivery format has the potential to significantly improve patient acceptance, simplify distribution without cold chain requirements, and expand the accessibility and public health impact of COVID-19 vaccination.

Under the terms of the agreement, Dynavax will pay Vaxart an upfront license fee of USD 25 million and make a USD 5 million equity investment. In return, Dynavax will receive exclusive, worldwide rights to develop and commercialise oral COVID-19 vaccines based on Vaxart’s delivery platform.

Vaxart will retain full operational and financial responsibility for the oral COVID-19 vaccine programme through the completion of the ongoing Phase 2b clinical trial and the subsequent End of Phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA). Following review of the Phase 2b data, Dynavax will have the right – but not the obligation – to assume future clinical development of Vaxart's oral COVID-19 vaccine programme.

If Dynavax elects to advance the programme, it will make an additional payment to Vaxart and also pay potential regulatory and commercial milestones payments and royalties on potential future net sales.  

"The agreement provides us with an exclusive license to a novel programme 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,” said Ryan Spencer, Chief Executive Officer of Dynavax.  

Vaxart's oral COVID-19 vaccine programme is powered by its proprietary VAAST (Vector-Adjuvant-Antigen Standardized Technology) platform, designed to deliver vaccines in a room-temperature stable pill. These vaccines are designed to generate broad and durable immune responses, including systemic, mucosal and T cell responses, which may enhance protection against certain infectious diseases, such as COVID-19.

Steven Lo, Chief Executive Officer of Vaxart, commented, "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.”

"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,” he added.

Vaxart’s ongoing Phase 2b clinical trial is a randomised, double-blind, multi-centre study comparing its oral COVID-19 vaccine candidate with an FDA-approved mRNA vaccine in previously immunised adults. The study’s primary goal is to assess the candidate’s efficacy in preventing symptomatic disease, with safety, tolerability and immune responses also being evaluated over a 12-month follow-up. Enrolling around 5,400 participants, the trial is funded through Project NextGen under a BARDA-supported contract, with topline results expected in late 2026.