Dynavax reports results from Phase 1/2 clinical trial of Z-1018

Dynavax (DVAX) Technologies presented positive topline data from Part 1 of its randomized, observer-blinded, active-controlled Phase 1/2 clinical trial of Z-1018, the Company’s novel shingles vaccine candidate, in a late-breaker session at IDWeek 2025. Dynavax also announced it has initiated Part 2 of the trial evaluating Z-1018 head-to-head versus Shingrix in older adults. Part 1 of the Phase 1/2 trial was a randomized, observer-blinded, active-controlled, dose escalation, multicenter trial to evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix in healthy adult participants aged 50 through 69 years. A key objective of Part 1 was to evaluate three different dose levels of gE antigen with two different adjuvant formulations, as well as 8-week and 12-week dosing regimens. The key safety endpoint was solicited local and systemic post-injection reactions, or PIRs, measured for up to seven days following each dose. The key immunogenicity endpoints included vaccine response rates, or VRR, for anti-gE IgG antibodies and gE-specific CD4+ T cells, assessed four weeks after the second study injection. VRRs were defined as participants with greater than or equal to 4-fold increase in anti-gE IgG concentration and, separately, greater than or equal to 2-fold increase in CD4+ T-cell frequency over baseline. Key highlights of the data presentation included: Z-1018 adjuvanted with CpG 1018 favorable tolerability and strong humoral and cellular responses across a range of Dynavax-produced gE dosage levels and dosing intervals; Z-1018 groups elicited high anti-gE IgG concentrations, robust CD4+ T-cell frequencies, and VRRs comparable to Shingrix, at 4 weeks after dose 2. In new data presented at IDWeek, Z-1018 induced a high proportion of polyfunctional CD4+ T-cell responses exhibiting multiple gE-specific activation markers, supporting the quality and breadth of the cellular immune response; Formulation consisting of 100 mcg gE adjuvanted with CpG 1018 plus alum, administered at 0 and 8 weeks, was selected for advancement to Part 2 of the Phase 1/2 trial in which adults aged 70 years and older are being enrolled. Dynavax also announced today that the first participants have been dosed in Part 2 of the Phase 1/2 clinical trial. Part 2 of the Phase 1/2 trial is a randomized, active-controlled, multicenter study expected to enroll approximately 324 healthy adults aged 70 years and older at trial sites in Australia and New Zealand.