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Details:
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
Therapeutic Area: Infections and Infectious Diseases Product Name: HEPLISAV-B
Highest Development Status: ApprovedProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2023
Details:
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.
Lead Product(s): HEPLISAV-B
Therapeutic Area: Infections and Infectious Diseases Product Name: HEPLISAV-B
Highest Development Status: Phase IIIProduct Type: Vaccine
Recipient: National Institute of Allergy and Infectious Diseases
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2022
Details:
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
Therapeutic Area: Infections and Infectious Diseases Product Name: rF1V
Highest Development Status: IND EnablingProduct Type: Vaccine
Partner/Sponsor/Collaborator: US Department of Defense
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 05, 2021
Details:
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.
Lead Product(s): VLA2001,CpG 1018,Aluminium Hydroxide
Therapeutic Area: Infections and Infectious Diseases Product Name: VLA2001
Highest Development Status: Phase IIIProduct Type: Vaccine
Recipient: Valneva
Deal Size: $1.4 million Upfront Cash: Undisclosed
Deal Type: Termination September 13, 2021
Details:
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].
Lead Product(s): BECOV2D,CpG 1018
Therapeutic Area: Infections and Infectious Diseases Product Name: Corbevax
Highest Development Status: Phase II/ Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Biological E
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 06, 2021
Details:
Clover to procure CpG 1018 adjuvant from Dynavax for use in the commercial production of Clover's COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum)
Lead Product(s): SCB-2019 Antigen,CpG 1018,Aluminium Hydroxide
Therapeutic Area: Infections and Infectious Diseases Product Name: SCB-2019
Highest Development Status: Phase II/ Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Clover Biopharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 30, 2021
Details:
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
Therapeutic Area: Infections and Infectious Diseases Product Name: Heplisav B
Highest Development Status: ApprovedProduct Type: Vaccine
Partner/Sponsor/Collaborator: Bavarian Nordic
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 27, 2021
Details:
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.
Lead Product(s): VLA2001,CpG 1018,Aluminium Hydroxide
Therapeutic Area: Infections and Infectious Diseases Product Name: VLA2001
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2021
Details:
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
Therapeutic Area: Infections and Infectious Diseases Product Name: Heplisav B
Highest Development Status: ApprovedProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 19, 2021
Details:
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.
Lead Product(s): CpG 1018,COVID-19 vaccine
Therapeutic Area: Infections and Infectious Diseases Product Name: CpG 1018
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: CEPI
Deal Size: $99.0 million Upfront Cash: Undisclosed
Deal Type: Funding February 01, 2021