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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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