Dynavax and Mount Sinai Announce Collaboration to Develop a Universal Influenza Vaccine Candidate with CpG 1018 Adjuvant

• Development funded under contract award from NIAID/NIH as part of the CIVICs program
  
• Currently no approved universal influenza vaccine
• CDC estimates 35.5 million people were infected with influenza in U.S. during 2018-2019 season
• Collaboration will combine Dynavax’s CpG 1018 with influenza antigens designed to protect against all strains of influenza

NEW YORK and EMERYVILLE, Calif., July 16, 2020 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and the Icahn School of Medicine at Mount Sinai (“Mount Sinai”) today announced they have entered into a collaboration to develop a universal influenza (flu) vaccine. Mount Sinai’s current work in this area is funded under a contract award from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), as part of the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program established by NIAID.  The Mount Sinai CIVICs team will evaluate a novel approach they have developed called chimeric hemagglutinin (cHA) designed to protect against all strains of influenza in combination with Dynavax’s CpG 1018^TM adjuvant.

The development program will support an Investigational New Drug (IND) application for Phase I clinical trials. Drs. Peter Palese, PhD, Professor and Chair of the Department of Microbiology at Mount Sinai, Adolfo-Garcia-Sastre, PhD, Director of the Global Health and Emerging Pathogens Institute, and the Irene and Dr. Arthur M. Fishberg Professor of Microbiology and Medicine (Infectious Diseases) at Mount Sinai, and Florian Krammer, PhD, Professor of Microbiology at Mount Sinai will be leading the development of the program.

There are no approved universal flu vaccines.  The effectiveness of seasonal influenza vaccine ranges between 10% and 60%. A universal vaccine could eliminate the need to update and administer the seasonal flu vaccine annually and could protect against newly emerging flu strains, potentially including those that could cause a flu pandemic.

“We are focused on designing novel vaccine candidates and delivery platforms with an emphasis on cross-protective vaccine strategies that could be used in healthy adults as well as populations at high risk for the most serious outcomes of influenza, such as children, older adults, and pregnant women,” said Peter Palese, PhD, Professor and Chair of the Department of Microbiology at the Icahn School of Medicine at Mount Sinai. “Including CpG 1018 in these vaccines gives us an important tool to potentially improve the immune response, especially in populations that need it most like the elderly.”