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Dynavax Technologies Corporation

HQ: Emeryville, CA source · dynavax.com ↗ · West Coast

FDA-approved therapeutic company Clinical Phase 2

For the diagnostic market, we have used our vaccine production technologies to manufacture and supply recombinant antigens. Dynavax wholly owns, manufactures and holds worldwide commercial rights to HEPLISAV-B. From company website Source · Oct 12, 2026

Keywords: diagnostic vaccine Vaccine-Preventable Diseases Hepatitis B rheumatoid arthritis skin inflammation lupus Shingles Herpes Zoster Chronic Kidney Disease Rhinitis, Allergic, Seasonal autoimmune diseases influenza Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia Pestis Pneumonic Plague Plague End Stage Renal Disease on Hemodialysis (Diagnosis) Pregnant Metastatic Melanoma Head Neck Cancer B-cell Lymphoma Advanced Non Small Cell Lung Cancer Chronic Hepatitis B Chronic Hepatitis C Colorectal Neoplasms End Stage Renal Disease hepatic fibrosis cirrhosis respiratory allergy Z-1018 SD-101 Engerix-B HEPLISAV-B® HEPLISAV-B DV281 DV281 (RP2D) DV-601 1018 ISS immunostimulatory oligonucleotide

Location: Emeryville, CA · source · Oct 15, 2026

Profile checked Oct 10, 2026

25Trials (company is sponsor)37NIH grants

Timeline

  1. Trial start Phase 2: Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age source ↗
  2. Trial start Phase 1/Phase 2: Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over source ↗
  3. Trial start Phase 2: Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age source ↗
  4. Trial start Phase 1: Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers source ↗
  5. Trial start —: DV2-HBV-27: Observational Pregnancy Registry source ↗
  6. Trial start Phase 1: HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis source ↗
  7. Trial start 1: Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC source ↗
  8. Trial start Phase 1/Phase 2: A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma source ↗
  9. Trial start Phase 1/Phase 2: Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma source ↗
  10. Trial start Phase 3: Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine source ↗
  11. Trial start Phase 1: A Study of the Immune Response to Heplisav in Healthy Older Adults source ↗
  12. Trial start Phase 3: Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis source ↗
  13. Trial start —: Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease source ↗
  14. Trial start Phase 3: Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine source ↗
  15. Trial start Phase 3: Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients source ↗
  16. Trial start Phase 1: A Study to Assess DV-601 in Subjects With Chronic Hepatitis B source ↗
  17. Trial start Phase 1: Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection source ↗
  18. Trial start Phase 1: Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males source ↗
  19. Trial start Phase 2: An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber source ↗
  20. Trial start Phase 2: A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease source ↗
  21. Trial start Phase 2: Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine source ↗
  22. Trial start Phase 3: Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine source ↗
  23. Trial start Phase 1: A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer source ↗
  24. Trial start Phase 2: Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults source ↗
  25. Trial start Phase 1: Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 25

RecordTitlePhaseStatusStartPrimary completion
NCT07207408Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of AgePhase 2Active, not recruitingSep 11, 2025Jan 29, 2027 (estimated)
NCT06569823Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and OverPhase 1/Phase 2Active, not recruitingJun 17, 20242027-11 (estimated)
NCT05506969Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of AgePhase 2CompletedAug 9, 2022Oct 3, 2023 (actual)
NCT03934736HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing HemodialysisPhase 1CompletedApr 22, 2019Oct 23, 2020 (actual)
NCT03664648DV2-HBV-27: Observational Pregnancy RegistryNot listedUnknown status (ClinicalTrials.gov)Feb 21, 20212024-09 (estimated)
NCT05245838Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult VolunteersPhase 1CompletedJan 10, 2022Oct 20, 2022 (actual)
NCT02521870A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaPhase 1/Phase 2Terminated2015-092020-04 (actual)
NCT00985426Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) PatientsPhase 3Completed2009-092012-01 (actual)
NCT02266147Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell LymphomaPhase 1/Phase 2Terminated2014-102017-04 (actual)
NCT03326752Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC1CompletedSep 20, 2017Sep 19, 2019 (actual)
NCT00511095Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus VaccinePhase 2Completed2007-062007-10 (actual)
NCT01023230A Study to Assess DV-601 in Subjects With Chronic Hepatitis BPhase 1Completed2009-092011-05 (actual)
NCT00537355An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure ChamberPhase 2Completed2007-092008-03 (actual)
NCT00823862Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) InfectionPhase 1Completed2008-102009-12 (actual)
NCT00403052A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal CancerPhase 1Terminated2006-112007-12 (actual)
NCT00599001Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal MalesPhase 1Completed2008-012008-03 (actual)
NCT00387738Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic AdultsPhase 2Terminated2006-042007-05 (actual)
NCT00498212A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal DiseasePhase 2Terminated2007-072008-08 (actual)
NCT02117934Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® VaccinePhase 3Completed2014-042015-10 (actual)
NCT01999699A Study of the Immune Response to Heplisav in Healthy Older AdultsPhase 1Completed2013-112015-02 (actual)
NCT01005407Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B VaccinePhase 3Completed2010-022011-01 (actual)
NCT00435812Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® VaccinePhase 3Completed2006-122008-02 (actual)
NCT01195246Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on HemodialysisPhase 3Completed2010-122012-02 (actual)
NCT01282762Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney DiseaseNot listedCompleted2010-122013-08 (actual)
NCT00426712Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure PatientsPhase 1Completed2006-012008-03 (actual)

NIH awards 37

Annual award amounts. Total $35.2M.

Raises and investors new

Form D raises come from the company’s own SEC filing (last 2 years).

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