Dynavax’s Z-1018 shingles vaccine shows efficacy in Phase 1/2 trial

Dynavax (DVAX) 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, 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 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 vs. Shingrix at 96.9%, and an 89.7% cellular immune vaccine response rate vs. 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. No safety concerns have been identified in this ongoing blinded study that has oversight by a safety monitoring committee. Based on these results, Dynavax has selected the 100 mcg dose of gE antigen, adjuvanted with CpG 1018 and alum, and using an 8-week dosing interval, to advance into Part 2 of the Phase 1/2 trial.