COVID-19: Dynavax to supply substance for Biological E’s COVID-19 vaccine candidate

Hyderabad: Biopharmaceutical company Dynavax Technologies Corporation and city-based vaccine and pharma company Biological E. Limited (BE), today announced the execution of a commercial supply agreement of Dynavax’s CpG 1018 TM advanced adjuvant, for use in BE’s subunit COVID-19 vaccine candidate, CORBEVAX™.

The commercial supply agreement extends through 2022, and includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between the Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax. Pending conditional regulatory approvals in India, BE expects to commence product launch of CORBEVAX™ later this year, said a press release from BE on Tuesday.

Last month, India’s union Ministry of Health announced that it finalised arrangements with BE to
reserve 300 million doses of CORBEVAX™ to be manufactured later this year. The arrangement with BE
is part of the wider endeavor from the government of India to encourage indigenous vaccine
manufacturers by providing financial support.

Ryan Spencer, chief executive officer of Dynavax said, “Dynavax is proud to extend our
collaboration with Biological E with a commercial supply agreement and deliver significant amounts of
CpG 1018 in hopes that CORBEVAX™ will be an important COVID-19 vaccine protecting people globally
regardless of income level.”

CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an
adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA) and the European
Commission.

On occasion of the the announcement, Mahima Datla, managing director of Biological E. Limited said, “We are pleased to collaborate with Dynavax and our collaboration will produce yet another vital
vaccine against the spread of COVID-19. We believe CORBEVAX™ will play a critical role in eradicating
the global pandemic.”

Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The
company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in
the U.S. and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Biological E. Limited (BE) is a Hyderabad-based pharmaceuticals and biologics company founded in 1953 and is also the first private sector biological products company in India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.