Dynavax Announces Exercise of Additional CpG 1018 Reservation Option to Produce 40 Million Doses of Valneva’s Inactivated and Adjuvanted COVID-19 Vaccine Candidate for the UK Government
EMERYVILLE, California., February 1, 2021 / PRNewswire / – Dynavax Technologies Company (Nasdaq: DVAX), a biopharmaceutical company focused on the development and commercialization of novel vaccines, today announced Valneva SE informed him that the UK government has exercised its option to order an additional 40 million doses of the adjuvanted SARS-CoV-2 vaccine candidate from Valneva, VLA2001. This option exercise triggers the reservation of additional quantities of Dynavax Advanced Adjuvant CpG 1018 to support the production of 40 million doses of Valneva’s SARS-CoV-2 adjuvanted vaccine candidate, VLA2001. As part of its contract with the British government, Valneva has now reserved for delivery in 2021 CpG 1018 in sufficient quantities to support the production of 100 million doses of VLA2001.
In September 2020, the companies announced a commercial partnership for the supply of Dynavax’s CpG 1018 adjuvant for use in VLA2001, to support Valneva’s agreement with the UK government to deliver up to 190 million doses of VLA2001 over a period of five years. Dynavax plans to supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase additional quantities of CpG 1018 to support production of an additional 90 million doses of VLA2001 through 2025 .
“Our commercial supply agreement with Valneva confirms our strategy of leveraging CpG 1018 as an advanced vaccine adjuvant for use in the development of safe and effective vaccines, including against COVID-19,” commented Ryan spencer, Chairman and CEO of Dynavax, “As part of this agreement, we are currently manufacturing, and expect to deliver, an adjuvant for 100 million doses of VLA2001 which would generate CpG 1018 sales of up to $ 230 million in 2021, subject to the delivery of materials and the continued success of the program. We believe the emerging portfolio of CpG 1018 opportunities has the potential to spur the next stage in Dynavax’s growth, adding to the substantial opportunity of HEPLISAV-B, our US FDA approved adult hepatitis B vaccine. . “
This commercial supply partnership follows the initial collaboration of Valneva and Dynavax to advance the development of the COVID-19 vaccine, announced in april 2020.
VLA2001 entered Phase 1/2 clinical studies in december 2020 and recently completed registration. Initial safety and immunogenicity data are awaited in April 2021.
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 United States Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an enhanced vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides well-developed technology and a large safety database, potentially accelerating the development and large-scale manufacture of a COVID-19 vaccine.
Dynavax is a commercial-stage biopharmaceutical company that develops and markets new vaccines. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following US FDA approval for the prevention of infections caused by all known subtypes of the hepatitis B virus in adults 18 years of age and older. Dynavax is also continuing the development of CpG 1018 as an advanced vaccine adjuvant through collaborations and research partnerships. Current collaborations focus on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information visit www.dynavax.com and follow the company on LinkedIn.
Dynavax forward-looking statements
This press release contains “forward-looking” statements, including statements regarding the potential development of a COVID-19 vaccine containing CpG 1018 and the commercial sale of CpG 1018 for use in the vaccine. Actual results may differ materially from those presented in this press release due to the risks and uncertainties inherent in vaccine research and development, including timing for completion of development, results of clinical trials, if and when the vaccine containing CpG 1018 will be approved for use, if and when purchases of CpG 1018 will take place, and the ability to manufacture a sufficient supply to meet purchasing needs, as well as other risks detailed in section “Risk Factors” of our Annual Report on Form 10-K for the Year Ended December 31, 2019 as well as discussions of potential risks, uncertainties and other important factors in our other filings with the United States Securities and Exchange Commission. We assume no obligation to revise or update the information contained in this document to reflect events or circumstances in the future, even if new information becomes available. Information on the Dynavax website at www.dynavax.com is not incorporated by reference into our current periodic relationship with the SEC.
Nicole arndt, Senior Director, Investor Relations
Derek cole, President
Investor Relations Consulting Solutions
SOURCE Dynavax Technologies