Benzinga | Jul 16, 2020 08:47AM EDT

Dynavax Reports Collaboration With Mount Sinai To Develop Universal Flu Vaccine Candidate With CpG 1018 Adjuvant

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 1018TM 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."

"We are excited to partner with Mount Sinai on this important vaccine development effort that has the potential to significantly reduce the morbidity and mortality caused by influenza viruses every year," commented Ryan Spencer, Chief Executive Officer of Dynavax. "Having seen the benefit of incorporating CpG 1018 in our first commercial vaccine, we believe it has significant potential to enhance the immune response in a universal flu vaccine. This effort directly aligns with Dynavax's goal to leverage the value of CpG 1018 across multiple diseases and vaccine approaches through collaborations with world class researchers like Mount Sinai."

"Drs. Palese, Garcia-Sastre and Krammer are key global opinion leaders in virology. Their collective research programs have resulted in technologies that support the development of a universal flu vaccine," said Erik Lium, PhD, Executive Vice President and Chief Commercial Innovation Officer at Mount Sinai. "In collaboration with Dynavax, we look forward to advancing these technologies to create an effective vaccine that can reduce the 3-5 million severe cases of influenza each year."

Influenza is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness. Serious outcomes of flu infection can result in hospitalization or death. Some people, such as older people, young children, and people with certain health conditions, are at high risk of serious flu complications. There are 2 epidemiological forms of influenza, seasonal and pandemic. Seasonal influenza epidemics, caused by influenza A and B viruses, result in 3--5 million severe cases and 300 000--500 000 deaths globally each year. Influenza pandemics caused by influenza A virus emerge at unpredictable intervals. They cause significantly increased morbidity and mortality, compared with seasonal influenza.

The U.S. Centers for Disease Control (CDC) annually estimates the burden of flu to the U.S. health system. CDC estimates that the burden of illness during the 2018--2019 season included an estimated 35.5 million people getting sick with influenza, 16.5 million people going to a health care provider for their illness, 490,600 hospitalizations, and 34,200 deaths from influenza.