Benzinga | Jul 14, 2020 08:18AM EDT

Dynavax Announces First Participants Dosed In Phase 1 Clinical Trial Evaluating Medicago's COVID-19 Vaccine Candidate With Dynavax's CpG 1018 Adjuvant

* Medicago expects to enroll 180 healthy adult participants

* Preliminary safety and immunogenicity results are expected in October 2020

* Dynavax is providing CpG 1018, the adjuvant contained in its U.S. FDA-approved adult hepatitis B vaccine, to enhance the immune response of Medicago's COVID-19 vaccine candidate

EMERYVILLE, Calif., July 14, 2020 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, announced today that the first participants have been dosed in the Phase 1 clinical trial evaluating Medicago's plant-derived vaccine candidate adjuvanted with CpG 1018 to prevent COVID-19.

The previously announced collaboration is evaluating the combination of Medicago's Coronavirus Virus-Like Particle (CoVLP) with Dynavax's CpG 1018, the adjuvant contained in Dynavax's U.S. FDA-approved adult hepatitis B vaccine. Adding CpG 1018 is intended to enhance the immune response of Medicago's COVID-19 vaccine which may reduce the amount of antigen required per dose, providing more doses to help protect a greater number of people.

"We are committed to supporting the development of an adjuvanted vaccine to prevent COVID-19," commented Ryan Spencer, Chief Executive Officer of Dynavax. "CpG 1018's ability to enhance the immune response, as successfully demonstrated in HEPLISAV-B, is expected to reduce the dose of antigen needed, helping ensure broader availability to patients. Additionally, the unique mechanism of action of CpG 1018 may provide important enhancements including increased protection in populations traditionally less responsive to vaccination such as older adults who are at greatest risk for severe disease from COVID-19."

The study is a Phase 1 randomized, partially-blinded, prime-boost, staggered dose-escalation study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 ?g, 7.5 ?g, and 15 ?g VLP) unadjuvanted or adjuvanted with either CpG 1018, or another company's adjuvant, in approximately 180 healthy subjects 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies. Preliminary safety and immunogenicity results are expected in October 2020. Medicago is also planning a Phase 2/3 trial to be initiated this October.

Medicago's innovative plant-based production platform will be used to manufacture the COVID-19 vaccine antigen. This platform uses plants as mini-factories which create proteins that self-assemble into the virus-like particles that are used in the CoVLP vaccine candidate. Combining Medicago's technology with Dynavax's CpG 1018 adjuvant, the companies expect to be able to deliver up to 100 million doses by the end of 2021. By the end of 2023, Medicago expects to complete the construction of a large-scale manufacturing facility in Quebec City, Canada that Medicago anticipates will have the capacity to produce up to 1 billion vaccine doses annually.