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Find Clinical Drug Pipeline Developments & Deals by Dynavax Technologies
Heplisav-B (adjuvanted recombinant hepatitis B vaccine) combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
Lead Product(s):
Adjuvanted Recombinant Hepatitis B Vaccine
HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] Solution for Intramuscular Injection,B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus.
Under the agreement, Dynavax will conduct a phase 2 clinical trial combining its CpG 1018 adjuvant with the DOD's rF1V vaccine. CpG 1018 is the adjuvant used in HEPLISAV-B.
Lead Product(s):
Recombinant Plague Vaccine,CpG 1018
Under Dynavax's existing supply agreement for CpG 1018, purchase orders submitted by Valneva are cancellable if the UK Government reduces or terminates its order for VLA2001, in which case, Valneva would not be obligated to pay Dynavax the final portion of purchase order.
Biological E to purchase CpG 1018 adjuvant from Dynavax for use in the commercial production of Biological E's COVID-19 vaccine candidate, CORBEVAX™. CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted].
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to enhance the immune response.
Lead Product(s):
Recombinant Hepatitis B Surface Antigen,CpG 1018
VLA2001, an inactivated COVID-19 vaccine candidate with CpG 1018 adjuvant, was highly immunogenic and generally safe and well tolerated. 100% seroconversion rate for S-protein binding IgG antibodies in the high dose group.
The approval and CHMP recommendation were based on the positive benefit-risk for HEPLISAV B as demonstrated by the safety and immunogenicity results of three Phase 3 clinical trials.
Lead Product(s):
Hepatitis B Vaccine (Recombinant) Adjuvanted
Under the terms of the agreement, CEPI will provide Dynavax funding of up to $99 million through a forgivable loan for the manufacturing of CpG 1018 with the potential to support hundreds of million doses of COVID-19 vaccine for delivery in 2021 through COVAX.
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