Dynavax's Shingles Vaccine Candidate Z-1018 Shows Comparable Immune Response To Shingrix With Fewer Side Effects; Advancing To Next Trial Phase In 2025

Author: Benzinga Newsdesk | August 21, 2025 07:11am

• At all doses and formulations evaluated in Part 1 of the trial, Z-1018 was well-tolerated and demonstrated a favorable tolerability profile, including lower solicited local and systemic post-injection reactions, versus Shingrix
• Z-1018 demonstrated robust immune responses in all dose arms, including a 100% humoral vaccine response rate at the dose selected for advancement, with comparable immunogenicity to Shingrix
• Dynavax selects the optimal dose of Z-1018 for advancement to Part 2 of Phase 1/2 trial in adults 70 years of age and older, expected to initiate in 2H 2025

EMERYVILLE, Calif., Aug. 21, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced positive topline results from Part 1 of its randomized, observer-blinded, and active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, head-to-head versus Shingrix in participants aged 50 to 69 years. Based on these results, Dynavax intends to advance Z-1018 into Part 2 of the Phase 1/2 program in adults 70 years of age and older, expected to initiate in the second half of 2025.

In Part 1 of the trial at one month after the second vaccine dose, Z-1018 demonstrated antibody and CD4⁺ T cell vaccine responses similar to those observed in the comparator arm receiving Shingrix, the currently licensed shingles vaccine, with a favorable tolerability profile. At the dose formulation and regimen chosen for advancing to Part 2 of the trial, Z-1018 achieved a 100.0% humoral vaccine response rate (antibody production) compared to Shingrix at 96.9%, and an 89.7% cellular immune vaccine response rate (CD4+ T-cell response) compared to Shingrix at 93.5%, resulting in a composite vaccine response rate of 89.7% for the Z-1018 group and 90.3% for Shingrix.

Z-1018 was also well-tolerated with a favorable safety profile in the study. Z-1018 exhibited low rates of grade 2 and 3 solicited local and systemic post-injection reactions (PIRs) in all dose, formulation, and dosing regimen arms. At the dose formulation and regimen chosen for advancement to Part 2 of the trial, 12.5% of participants receiving Z-1018 reported grade 2 or 3 local PIRs and 27.5% reported grade 2 or 3 systemic PIRs, versus 52.6% and 63.2% for Shingrix, respectively. No safety concerns have been identified in this ongoing blinded study that has oversight by a safety monitoring committee.

Posted In: DVAX