By NewsDesk  @infectiousdiseasenews

Biopharmaceutical company focused on developing and commercializing vaccines, Dynavax Technologies Corporation, 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.

Bipolar staining of a plague smear prepared from lymph aspirated from an adenopathic lymph node, or bubo, of a plague patient./CDC

Ryan Spencer, Dynavax’s Chief Executive Officer commented, “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.  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.”

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.

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. It is possible that Pneumonic plague bacteria could be released intentionally in a biological attack to sicken people.

CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.