COMPANY
Dynavax Technologies Corporation
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
Timeline
- Trial start Phase 2: Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age source ↗
- 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 ↗
- 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 ↗
- 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 ↗
- Trial start —: DV2-HBV-27: Observational Pregnancy Registry source ↗
- Trial start Phase 1: HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis source ↗
- Trial start 1: Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC source ↗
- 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 ↗
- 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 ↗
- Trial start Phase 3: Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine source ↗
- Trial start Phase 1: A Study of the Immune Response to Heplisav in Healthy Older Adults source ↗
- Trial start Phase 3: Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis source ↗
- Trial start —: Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease source ↗
- Trial start Phase 3: Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine source ↗
- Trial start Phase 3: Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients source ↗
- Trial start Phase 1: A Study to Assess DV-601 in Subjects With Chronic Hepatitis B source ↗
- 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 ↗
- Trial start Phase 1: Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males source ↗
- Trial start Phase 2: An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber source ↗
- 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 ↗
- Trial start Phase 2: Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine source ↗
- Trial start Phase 3: Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine source ↗
- 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 ↗
- Trial start Phase 2: Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults source ↗
- Trial start Phase 1: Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients source ↗
Upcoming milestones
- Jan 29, 2027 (ESTIMATED) · Phase 2 · Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age · NCT07207408
- 2027-11 (ESTIMATED) · 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 · NCT06569823
Clinical trials (lead sponsor) 25
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07207408 | Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age | Phase 2 | Active, not recruiting | Sep 11, 2025 | Jan 29, 2027 (estimated) |
| NCT06569823 | Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over | Phase 1/Phase 2 | Active, not recruiting | Jun 17, 2024 | 2027-11 (estimated) |
| NCT05506969 | 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 | Phase 2 | Completed | Aug 9, 2022 | Oct 3, 2023 (actual) |
| NCT03934736 | HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis | Phase 1 | Completed | Apr 22, 2019 | Oct 23, 2020 (actual) |
| NCT03664648 | DV2-HBV-27: Observational Pregnancy Registry | Not listed | Unknown status (ClinicalTrials.gov) | Feb 21, 2021 | 2024-09 (estimated) |
| NCT05245838 | Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers | Phase 1 | Completed | Jan 10, 2022 | Oct 20, 2022 (actual) |
| NCT02521870 | 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 | Phase 1/Phase 2 | Terminated | 2015-09 | 2020-04 (actual) |
| NCT00985426 | Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients | Phase 3 | Completed | 2009-09 | 2012-01 (actual) |
| NCT02266147 | Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma | Phase 1/Phase 2 | Terminated | 2014-10 | 2017-04 (actual) |
| NCT03326752 | Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC | 1 | Completed | Sep 20, 2017 | Sep 19, 2019 (actual) |
| NCT00511095 | Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine | Phase 2 | Completed | 2007-06 | 2007-10 (actual) |
| NCT01023230 | A Study to Assess DV-601 in Subjects With Chronic Hepatitis B | Phase 1 | Completed | 2009-09 | 2011-05 (actual) |
| NCT00537355 | An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber | Phase 2 | Completed | 2007-09 | 2008-03 (actual) |
| NCT00823862 | 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 | Phase 1 | Completed | 2008-10 | 2009-12 (actual) |
| NCT00403052 | A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer | Phase 1 | Terminated | 2006-11 | 2007-12 (actual) |
| NCT00599001 | Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males | Phase 1 | Completed | 2008-01 | 2008-03 (actual) |
| NCT00387738 | Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults | Phase 2 | Terminated | 2006-04 | 2007-05 (actual) |
| NCT00498212 | A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease | Phase 2 | Terminated | 2007-07 | 2008-08 (actual) |
| NCT02117934 | Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine | Phase 3 | Completed | 2014-04 | 2015-10 (actual) |
| NCT01999699 | A Study of the Immune Response to Heplisav in Healthy Older Adults | Phase 1 | Completed | 2013-11 | 2015-02 (actual) |
| NCT01005407 | Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine | Phase 3 | Completed | 2010-02 | 2011-01 (actual) |
| NCT00435812 | Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine | Phase 3 | Completed | 2006-12 | 2008-02 (actual) |
| NCT01195246 | Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis | Phase 3 | Completed | 2010-12 | 2012-02 (actual) |
| NCT01282762 | Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease | Not listed | Completed | 2010-12 | 2013-08 (actual) |
| NCT00426712 | Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients | Phase 1 | Completed | 2006-01 | 2008-03 (actual) |
NIH awards 37
- NIH award 5R44AI100376-04 FY2017: $422,785 awarded for that fiscal year; activity R44 (SBIR); PI CANDIA, ALBERT F; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Developing small molecule inhib source ↗
- NIH award 2R44AI100376-03 FY2016: $589,482 awarded for that fiscal year; activity R44 (SBIR); PI CANDIA, ALBERT F; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Developing small molecule inhib source ↗
- NIH award 5R21OD018317-02 FY2015: $198,117 awarded for that fiscal year; activity R21 (OTHER_NIH); PI GUIDUCCI, CRISTIANA; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Generation of a Transge source ↗
- NIH award 1R21OD018317-01 FY2014: $227,161 awarded for that fiscal year; activity R21 (OTHER_NIH); PI GUIDUCCI, CRISTIANA; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Generation of a Transge source ↗
- NIH award 1R41DK101221-01 FY2013: $223,390 awarded for that fiscal year; activity R41 (STTR); PI CANDIA, ALBERT F; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. The Development of TLR Antagoni source ↗
- NIH award 5R43AI100376-02 FY2013: $105,088 awarded for that fiscal year; activity R43 (SBIR); PI COFFMAN, ROBERT L; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Screening for Inhibitors of TL source ↗
- NIH award 5R43AI096641-02 FY2013: $299,508 awarded for that fiscal year; activity R43 (SBIR); PI GUIDUCCI, CRISTIANA; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Development of TLR8 inhibito source ↗
- NIH award 5R43AI092929-02 FY2012: $292,359 awarded for that fiscal year; activity R43 (SBIR); PI GUIDUCCI, CRISTIANA; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Inhibitors of PI3K-delta for source ↗
- NIH award 1R43AI100376-01A1 FY2012: $299,830 awarded for that fiscal year; activity R43 (SBIR); PI COFFMAN, ROBERT L; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Screening for Inhibitors of source ↗
- NIH award 1R43AI096641-01A1 FY2012: $299,508 awarded for that fiscal year; activity R43 (SBIR); PI GUIDUCCI, CRISTIANA; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Development of TLR8 inhibi source ↗
- NIH contract (government contract; not a grant and not an investment round) 272200800038C-5-0-1 FY2012: $2,248,871 awarded for that fiscal year; activity N01 (OTHER_NIH); PI LANGE, LAURA; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Ad source ↗
- NIH award 1R43AI092929-01 FY2011: $297,225 awarded for that fiscal year; activity R43 (SBIR); PI GUIDUCCI, CRISTIANA; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Inhibitors of PI3K-delta for source ↗
- NIH award 5R43CA154078-02 FY2011: $297,200 awarded for that fiscal year; activity R43 (SBIR); PI HILLEBRAND, ANNETTE; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Development of an L2-based H source ↗
- NIH contract (government contract; not a grant and not an investment round) 272200800038C-3-0-1 FY2011: $9,711,242 awarded for that fiscal year; activity N01 (OTHER_NIH); PI SEAMON, BRADFORD; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA source ↗
- NIH award 1R43CA154078-01 FY2010: $298,625 awarded for that fiscal year; activity R43 (SBIR); PI HILLEBRAND, ANNETTE; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Development of an L2-based H source ↗
- NIH award 5R43AI082839-02 FY2010: $360,909 awarded for that fiscal year; activity R43 (SBIR); PI BARRAT, FRANCK; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Inhibitors of Toll-like receptors source ↗
- NIH award 5R44AI066483-03 FY2009: $932,510 awarded for that fiscal year; activity R44 (SBIR); PI COFFMAN, ROBERT L; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Development of an inhibitory o source ↗
- NIH award 1R43AI082839-01 FY2009: $359,430 awarded for that fiscal year; activity R43 (SBIR); PI BARRAT, FRANCK; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Inhibitors of Toll-like receptors source ↗
- NIH contract (government contract; not a grant and not an investment round) 272200800038C-2-0-1 FY2009: $1,673,631 awarded for that fiscal year; activity N01 (OTHER_NIH); PI VAN NEST, GARY A; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA source ↗
- NIH award 5U01AI074578-02 FY2008: $1,616,687 awarded for that fiscal year; activity U01 (OTHER_NIH); PI VAN NEST, GARY A; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Production of an NP-ISS source ↗
- NIH award 2R44AI066483-02 FY2008: $878,519 awarded for that fiscal year; activity R44 (SBIR); PI COFFMAN, ROBERT L; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Development of an inhibitory o source ↗
- NIH contract (government contract; not a grant and not an investment round) 272200800038C-1-0-1 FY2008: $3,227,796 awarded for that fiscal year; activity N01 (OTHER_NIH); PI n/a; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Adjuvant De source ↗
- NIH award 1U01AI074578-01 FY2007: $1,600,000 awarded for that fiscal year; activity U01 (OTHER_NIH); PI VAN NEST, GARY A; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Production of an NP-ISS source ↗
- NIH award 1R43AI066483-01A1 FY2006: $207,278 awarded for that fiscal year; activity R43 (SBIR); PI COFFMAN, ROBERT L; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Development of an Inhibitory source ↗
- NIH award 5U01AI056447-04 FY2006: $1,767,169 awarded for that fiscal year; activity U01 (OTHER_NIH); PI VAN NEST, GARY A; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. ISS-linked NP vaccine to source ↗
- NIH award 5U01AI056559-04 FY2006: $2,098,735 awarded for that fiscal year; activity U01 (OTHER_NIH); PI VAN NEST, GARY A; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Advanced anthrax vaccine source ↗
- NIH award 5U01AI056435-03 FY2005: $202,329 awarded for that fiscal year; activity U01 (OTHER_NIH); PI COFFMAN, ROBERT L; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Immunostimulatory DNA Pri source ↗
- NIH award 5U01AI056447-03 FY2005: $534,847 awarded for that fiscal year; activity U01 (OTHER_NIH); PI VAN NEST, GARY A; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. ISS-linked NP vaccine to c source ↗
- NIH award 5U01AI056559-03 FY2005: $816,464 awarded for that fiscal year; activity U01 (OTHER_NIH); PI VAN NEST, GARY A; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Advanced anthrax vaccine m source ↗
- NIH award 5U01AI056435-02 FY2004: $759,577 awarded for that fiscal year; activity U01 (OTHER_NIH); PI COFFMAN, ROBERT L; recipient as written: DYNAVAX TECHNOLOGIES CORPORATION, BERKELEY, CA. Immunostimulatory DNA Pri source ↗
Raises and investors new
- InvestorListed in the portfolio of Bain Capital Life Sciences (captured Oct 12, 2026). portfolio page ↗