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Dynavax and Sinovac Announce Collaboration to Develop a Coronavirus (COVID-19) Vaccine

  • The collaboration will combine Dynavax’s CpG 1018, the adjuvant contained in U.S. FDA-approved HEPLISAV-B vaccine, with Sinovac’s chemically inactivated coronavirus vaccine candidate

EMERYVILLE, Calif., April 16, 2020 (GLOBE NEWSWIRE) — Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that they have entered into a collaboration to develop a vaccine to prevent COVID-19. The collaboration will evaluate the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate, with Dynavax’s advanced adjuvant, CpG 1018.

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 of a coronavirus vaccine. Additionally, CpG 1018 is manufactured using a highly automated, robust, scalable process capable of producing the large quantities required in a pandemic.

“The breadth of the global healthcare community’s efforts to develop an effective vaccine to prevent COVID-19 has been enabled by the prior research and investment in infectious disease understanding and prevention,” commented Ryan Spencer, Chief Executive Officer of Dynavax. “A collaborative approach across multiple technology platforms enables us to demonstrate the potential for our adjuvant to lead to a safe and effective vaccine to prevent COVID-19.  We hope the prior clinical experience and significant safety database of CpG 1018 will enable a rapid development process for a coronavirus vaccine.”

About the Novel Coronavirus SARS-CoV-2 (and COVID-19 Disease)
SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of respiratory system.  The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported in late-2019, the virus has infected over 1.9 million people and has caused over 123,000 reported deaths (as of April 14, 2020). It has been declared a pandemic by the World Health Organization (WHO).  Currently there is no vaccine available for COVID-19.

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 expanding utilization of CpG 1018 as an advanced vaccine adjuvant through research collaborations and partnerships.  For more information, visit www.dynavax.com and follow the company on LinkedIn.

About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, a quadrivalent influenza vaccine and a SARS-CoV-2 (commonly referred to as COVID-19) vaccine. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is distributing its products in over 15 countries outside of China. For more information please see the Company’s website at www.sinovac.com.

Forward-Looking Statements
This press release contains “forward-looking” statements, including statements regarding the potential to develop a COVID-19 vaccine and to do so on an accelerated basis.  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, including the timing of completing development, the results of clinical trials, and whether and when the vaccine will be approved for use, 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.

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

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

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