Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Z-1018
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Dynavax Initiates Phase 1/2 Study of Novel Shingles Vaccine Program
Details : Z-1018 is an investigational shingles vaccine candidate that uses Dynavax's CpG 1018 adjuvant to enhance the immune response. It ie being evaluated for prevention of shingles (herpes zoster).
Product Name : Z-1018
Product Type : Vaccine
Upfront Cash : Inapplicable
June 27, 2024
Lead Product(s) : Z-1018
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US FDA declines expanded use of Dynavax's hepatitis B vaccine on insufficient data
Details : Heplisav-B (adjuvanted recombinant hepatitis B vaccine) is a single-dose, prefilled syringe given intramuscularly. FDA in its CRL declines the expanded use of vaccine due to insufficient data.
Product Name : Heplisav-B
Product Type : Vaccine
Upfront Cash : Inapplicable
May 14, 2024
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Dynavax Updates On HEPLISAV-B sBLA For Hemodialysis Patients
Details : sBLA has been submitted to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults with hepatitis-B on hemodialysis.
Product Name : Heplisav-B
Product Type : Vaccine
Upfront Cash : Inapplicable
May 14, 2024
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Heplisav-B
Product Type : Vaccine
Upfront Cash : Inapplicable
February 28, 2023
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : SCB-2019,Aluminium Hydroxide,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II/ Phase III
Sponsor : Clover Biopharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
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)
Product Name : SCB-2019
Product Type : Vaccine
Upfront Cash : Undisclosed
June 30, 2021
Lead Product(s) : SCB-2019,Aluminium Hydroxide,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II/ Phase III
Sponsor : Clover Biopharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : BECOV2D,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II/ Phase III
Sponsor : Biological E
Deal Size : Undisclosed
Deal Type : Agreement
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].
Product Name : Corbevax
Product Type : Vaccine
Upfront Cash : Undisclosed
June 07, 2021
Lead Product(s) : BECOV2D,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II/ Phase III
Sponsor : Biological E
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : VLA2001,Aluminium Hydroxide,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : VLA2001
Product Type : Vaccine
Upfront Cash : Inapplicable
June 04, 2021
Lead Product(s) : VLA2001,Aluminium Hydroxide,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Bavarian Nordic
Deal Size : Undisclosed
Deal Type : Agreement
Dynavax Announces Agreement with Bavarian Nordic for Commercialization of HEPLISAV B®
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.
Product Name : Heplisav-B
Product Type : Vaccine
Upfront Cash : Undisclosed
May 27, 2021
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Bavarian Nordic
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Plague Vaccine Recombinant,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Study Phase : IND Enabling
Sponsor : US Department of Defense
Deal Size : Undisclosed
Deal Type : Collaboration
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.
Product Name : rF1V
Product Type : Vaccine
Upfront Cash : Undisclosed
May 10, 2021
Lead Product(s) : Plague Vaccine Recombinant,CPG ODN 1018
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Sponsor : US Department of Defense
Deal Size : Undisclosed
Deal Type : Collaboration
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Heplisav-B
Product Type : Vaccine
Upfront Cash : Inapplicable
February 19, 2021
Lead Product(s) : Hepatitis B Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable