On Oct. 4, 2021, Dynavax Technologies and the U.S. Department of Defense (DOD) announced Dynavax has executed 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.

This agreement, funded 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), enables Dynavax to conduct a Phase 2 clinical trial, 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. Any future commercial supply agreements would be subject to a separate agreement between Dynavax and the U.S government.

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.