Dynavax and Vaxart Join Forces on Oral COVID-19 Vaccine Development

Dynavax and Vaxart's Innovative Collaboration on Oral COVID-19 Vaccine

In a groundbreaking development in the fight against COVID-19, Dynavax Technologies Corporation has announced its entry into an exclusive license agreement with Vaxart, Inc. This collaboration is set to utilize Vaxart's novel oral vaccine platform combined with Dynavax's expertise in commercializing vaccines. This partnership aims to address the ongoing demand for easily administered vaccination options, particularly in the wake of the pandemic.

The Unique Position of the Oral Vaccine

Vaxart’s investigational oral vaccine candidate differentiates itself from typical COVID-19 vaccines by employing a unique mechanism of action. By being delivered in pill form, this vaccine is designed to stimulate mucosal immunity at the entry points of the respiratory tract. This approach is anticipated to not only inhibit the infection but also lessen the transmission and severity of the disease, reducing the public health impact of COVID-19.

Moreover, the oral delivery mechanism simplifies distribution as it does not require cold chain logistics, which can often hinder the availability of vaccines, especially in remote or underserved regions. The easy administration of an oral vaccine is also expected to increase patient acceptance and compliance, a crucial factor in achieving widespread immunization.

Financial Aspects of the Agreement

Under the terms of the agreement, Dynavax will provide Vaxart with an upfront payment of $25 million. It will also invest an additional $5 million in equity. Furthermore, Dynavax will gain exclusive worldwide rights to develop and commercialize the oral COVID-19 vaccine once Vaxart completes the ongoing Phase 2b clinical trial and meets with the FDA for an End of Phase 2 assessment.

Following the conclusion of this trial, Dynavax can decide whether to take on further development responsibilities and, if it chooses to do so, may owe Vaxart an additional $50 million. In addition, Vaxart stands to earn up to $195 million in regulatory milestone payments and an expected tiered royalty on future sales.

Ongoing Development and Future Prospects

As for the current status of Vaxart's oral COVID-19 vaccine, the company is conducting a pivotal Phase 2b randomized, double-blind, multi-center trial. This trial aims to compare the efficacy of Vaxart's oral vaccine against an approved injectable mRNA COVID-19 vaccine. The primary goal will be evaluating the prevention of symptomatic COVID-19 in adults who have already received prior vaccinations. Topline results from this extensive study are expected to be disclosed in late 2026.

The trial is backed by funding from Advanced Technology International, through a contract supported by BARDA, as part of Project NextGen, which aims to enhance the nation's preparedness for future infectious disease threats.

Statements on the Collaboration

Ryan Spencer, CEO of Dynavax, expressed enthusiasm about the collaboration, highlighting not only the innovative nature of Vaxart’s oral vaccine candidate but also the importance of enhancing patient access to vaccines. He stated, "This collaboration exemplifies our disciplined approach to external innovation and long-term value creation. It addresses the pressing need for vaccine options that can reach more people, more efficiently."

On the other hand, Steven Lo, CEO of Vaxart, shared a positive outlook on the partnership, asserting that Dynavax’s investment significantly bolsters the clinical prospects of Vaxart's vaccine platform, facilitating a promising route ahead for oral vaccine technology.

Conclusion

As the world continues to adapt to life with COVID-19, collaborations like that between Dynavax and Vaxart are pivotal in devising solutions that ensure greater vaccine access and effectiveness. The anticipated oral COVID-19 vaccine has the potential not only to improve delivery and acceptance but also to transform public health approaches towards infectious disease control. With further results from the ongoing trials, this partnership is one to watch closely as it may redefine vaccine distribution worldwide.