Dynavax Announces First Participant Dosed in a Phase 2 Clinical Trial Evaluating an Adjuvanted Plague Vaccine

EMERYVILLE, CA, USA I September 12, 2022 I Dynavax Technologies Corporation ( Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, in collaboration with the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and supported by the DOD's Chemical and Biological Defense Program, today announced that the first participant has been dosed in a Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability of the JPEO-CBRND's Recombinant Plague (rF1V) vaccine combined with Dynavax's CpG 1018®adjuvant, in adults 18 to 55 years of age.

"We are proud to support the U.S. government in developing an effective adjuvanted plague vaccine that we believe will allow U.S. service members to be protected with fewer doses administered over a shorter period of time," commented Ryan Spencer, Chief Executive Officer of Dynavax. "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."

As previously announced, Dynavax and the DOD executed an agreement which provides for approximately $22 million in funding over two and a half years to develop an improved recombinant plague vaccine adjuvanted with CpG 1018 adjuvant.  Under the agreement, Dynavax will conduct a Phase 2 clinical trial combining its CpG 1018 adjuvant with the DOD's rF1V vaccine. The trial is assessing a two-dose regimen administered over one month. Previous clinical studies of the rF1V, not including CpG 1018 adjuvant, have evaluated a three-dose regimen over six months. Any future commercial supply agreements would be subject to a separate agreement between Dynavax and the U.S government.

About CpG 1018 Adjuvant

Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response with an improved tolerability profile, which has been demonstrated in HEPLISAV-B vaccine for adult hepatitis B and multiple COVID-19 vaccines that have received Emergency Use Authorization outside of the U.S. CpG 1018 adjuvant provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of novel or improved vaccines.

About Dynavax 

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S. and the European Union for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in multiple adjuvanted COVID-19 vaccines. Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant through global research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, seasonal influenza, universal influenza, plague, shingles and Tdap. For more information about our marketed products and development pipeline, visit www.dynavax.com and follow Dynavax on LinkedIn.

SOURCE: Dynavax Technologies

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