Press Release

Dynavax Announces Grant to Scale up CpG 1018 Adjuvant Capacity to Support the Global COVID-19 Response

Aug 13, 2020 at 8:00 AM EDT

EMERYVILLE, Calif., Aug. 13, 2020 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced a grant from the Bill & Melinda Gates Foundation of $3.4 million to scale up production batch size to allow for increased capacity of Dynavax’s CpG 1018 advanced adjuvant to support the global COVID-19 response. These efforts will support capacity of up to 750 million adjuvant doses annually, which can be further increased if needed.

“We are honored to receive this funding from the Bill & Melinda Gates Foundation to support development of a much-needed vaccine for COVID-19. This grant facilitates scale up of production capacity to ensure the availability of CpG 1018 for collaboration partners developing adjuvanted vaccines for COVID-19,” commented Ryan Spencer, Chief Executive Officer of Dynavax. “We believe adjuvants will play an important role in developing effective vaccines for COVID-19, including for those patients at greatest risk for severe disease. The ability of CpG 1018 to potentially provide an improved immune response and also reduce the amount of vaccine antigen necessary will help provide more vaccine doses to meet the global need.”

About Vaccine Adjuvants
An adjuvant is a pharmacological or immunological agent that modifies the effect of other agents. Adjuvants are added to a vaccine to boost the immune response to produce more antibodies and longer-lasting immunity, thus minimizing the dose of antigen needed. Adjuvants may also be used to enhance the efficacy of a vaccine by helping to modify the immune response by particular types of immune system cells.

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

About Dynavax
Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also further developing CpG 1018 as an advanced vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19 and pertussis. For more information, visit www.dynavax.com and follow the company on LinkedIn.

About the Novel Coronavirus SARS-CoV-2 (and COVID-19 Disease)
SARS-CoV-2 is a new coronavirus identified in late 2019 which belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus causes a disease named COVID-19. Since this outbreak was first reported in late 2019, the virus has infected over 19.9 million people and has caused over 732,000 reported deaths (as of August 11, 2020). It has been declared a pandemic by the World Health Organization (WHO). Currently there is no vaccine available for COVID-19.

Dynavax Forward-Looking Statements
This press release contains "forward-looking" statements, including statements regarding potential benefits of using CpG 1018 as an adjuvant in a COVID-19 vaccine and the ability to increase CpG 1018 manufacturing capacity. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, and whether the CpG 1018 manufacturing scale up activities will result in the ability to manufacture the number of CpG 1018 adjuvant doses projected, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

Nicole Arndt, Senior Manager, Investor Relations
narndt@dynavax.com
510-665-7264

Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com


dynavax_logo_notagline.jpg

Source: Dynavax Technologies Corporation