Dynavax Technologies Corporation and the U.S. Department of Defense (DOD) today announced an agreement for approximately $22 million over two and a half years to develop a recombinant plague vaccine adjuvanted with CpG 1018.
Under the agreement, Dynavax will conduct a Phase 2 clinical trial combining its CpG 1018 adjuvant with the DOD’s rF1V vaccine. The Company anticipates the Phase 2 trial will commence in 2022.
Plague is a potentially deadly infectious disease caused by bacteria found in fleas and rodents or by handling an animal infected with plague. It is caused by the bacterium, Yersinia pestis, classified as a Tier 1 Biological Select Agent and Toxin.
Pending a successful trial outcome, the company will submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), and generate additional clinical trial results to add to the existing clinical and non-clinical data under the contract terms. Any future commercial supply agreements would be subject to a separate agreement.
The contract is part of the portfolio managed by the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical).
“Advancing the development of a recombinant plague vaccine supports the JPM CBRN Medical’s vision to deliver a full, layered medical countermeasure capability to enable a protected and unencumbered Joint Force to fight and win in any global CBRN battlespace,” noted COL Ryan Eckmeier, the Joint Project Manager for CBRN Medical. “Incorporating the CpG 1018 adjuvant to the DOD’s rF1V vaccine will hopefully allow us to protect our service members with fewer doses administered over a shorter time period.”
The planned Phase 2 randomized, placebo-controlled, observer-blind, multicenter clinical trial will evaluate the immunogenicity, safety, and tolerability of the rF1V vaccine antigens provided by the U.S. government combined with Dynavax’s CpG 1018 adjuvant in adults 18 to 55 years of age.
Sources: Adapted from Dynavax, JPEO-CBRND