The United States Department of Defense (DoD) awarded an agreement worth approximately $22 million to the biopharmaceutical developer Dynavax Technologies Corporation this week, giving it two and a half years to develop an adjuvanted recombinant plague vaccine.
That vaccine will be adjuvanted with Dynavax’s own CpG 1018, which provides an increased vaccine immune response, as best demonstrated in the HEPLISAV-B hepatitis B vaccine. Now, Dynavax intends to apply it to the DoD’s rF1V vaccine in a Phase 2 trial beginning in 2022.
“We are honored to receive this award and to support the U.S. government in developing a plague vaccine to protect the U.S. military members who put their lives at risk every day in service to the country,” Ryan Spender, Dynavax CEO, said. “The development of a CpG 1018 adjuvanted plague vaccine is an important example of the broad utility of our adjuvant which we are leveraging to build our pipeline of new and improved vaccines. Our confidence in CpG 1018 is built on the successful development of our FDA-licensed 2-dose adult hepatitis B vaccine and the multiple late-stage COVID-19 vaccine candidates utilizing CpG 1018.”
The planned Phase 2 trial will be randomized, observer-blind and placebo-controlled across multiple clinical centers, during which researchers will evaluate the adjuvanted vaccines immunogenicity safety and tolerability. It will be tested on adults between 18 and 55 years old. After the trial, Dynavax will submit an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) and pursue any additional clinical trials needed to supplement existing clinical and non-clinical data.
What the current arrangement notably excludes is supply. If the adjuvanted vaccine is eventually approved, Dynavax and the U.S. government would need to create a separate commercial supply arrangement.