Dynavax (DVAX) Announces Exercise of Option to Reserve Additional CpG 1018 to Produce 40 Million Doses of Valneva's Inactivated, Adjuvanted COVID-19 Vaccine Candidate for the UK Government

February 1, 2021 7:07 AM EST

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Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced Valneva SE has informed it that the UK Government exercised its option to order an additional 40 million doses of Valneva's SARS-CoV-2 adjuvanted vaccine candidate, VLA2001. This option exercise triggers the reservation of additional quantities of Dynavax's advanced adjuvant CpG 1018 to support production of 40 million doses of Valneva's SARS-CoV-2 adjuvanted vaccine candidate, VLA2001. In connection with its contract with the UK Government, Valneva has now reserved for delivery in 2021 CpG 1018 in quantities sufficient to support 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 U.K. government to provide up to 190 million doses of VLA2001 over a five-year period. Dynavax expects 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 the production of up to an additional 90 million doses of VLA2001 through 2025.

"Our commercial supply agreement with Valneva substantiates 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, Chief Executive Officer of Dynavax, "Under this agreement, we are currently manufacturing, and scheduled to deliver, adjuvant for 100 million doses of VLA2001 which would generate CpG 1018 revenue of up to $230 million in 2021, contingent on delivery of material and the continued success of the program. We believe the emerging portfolio of CpG 1018 opportunities has the potential to drive the next leg of Dynavax growth, adding to the substantial opportunity of HEPLISAV-B, our U.S. FDA approved adult hepatitis B vaccine."

This commercial supply partnership follows Valneva and Dynavax's initial collaboration to advance COVID-19 vaccine development, announced in April 2020.

VLA2001 entered Phase 1/2 clinical studies in December 2020 and has recently completed enrollment. Initial safety and immunogenicity data are expected in April 2021.



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