Core Insights - Dynavax Technologies Corporation has presented positive topline data from Part 1 of its Phase 1/2 clinical trial for Z-1018, a novel shingles vaccine candidate, and has initiated Part 2 of the trial to evaluate Z-1018 against Shingrix in older adults [1][3] Company Overview - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines, including HEPLISAV-B for hepatitis B and the CpG 1018 adjuvant used in various vaccines [8] Clinical Trial Details - Part 1 of the Phase 1/2 trial was a randomized, observer-blinded, active-controlled, dose escalation study assessing the safety, tolerability, and immunogenicity of Z-1018 in healthy adults aged 50 to 69 years, evaluating three different dose levels of gE antigen and two adjuvant formulations [2][5] - The key safety endpoint was solicited local and systemic post-injection reactions measured for up to seven days post-injection, while key immunogenicity endpoints included vaccine response rates for anti-gE IgG antibodies and gE-specific CD4+ T cells [2] Part 2 Trial Initiation - Part 2 of the trial has been initiated, enrolling approximately 324 healthy adults aged 70 years and older, aimed at further characterizing immunogenicity, safety, and tolerability of Z-1018 compared to Shingrix [3][6] - The company anticipates reporting topline immunogenicity and safety data from Part 2 in the second half of 2026 [3] Vaccine Performance - Z-1018 demonstrated comparable antibody and CD4+ T-cell responses to Shingrix with a favorable tolerability profile, showing robust polyfunctional CD4+ T-cell responses [5][6] - The formulation selected for advancement in Part 2 consists of 100 mcg gE adjuvanted with CpG 1018 plus alum, administered at 0 and 8 weeks [6][7] Shingles Background - Shingles, caused by the reactivation of the varicella-zoster virus, affects approximately 1 in 3 people in their lifetime and can lead to serious complications, particularly in older adults [4]

Core Insights - Dynavax Technologies Corporation announced positive topline results from Part 1 of its Phase 1/2 clinical trial for Z-1018, a novel shingles vaccine candidate, showing comparable immune responses to Shingrix in adults aged 50 to 69 years [1][4] Group 1: Clinical Trial Results - Z-1018 achieved a 100.0% humoral vaccine response rate compared to Shingrix's 96.9%, and an 89.7% cellular immune response rate versus Shingrix's 93.5%, resulting in a composite vaccine response rate of 89.7% for Z-1018 and 90.3% for Shingrix [2][8] - The trial demonstrated Z-1018's favorable safety profile, with lower rates of grade 2 and 3 post-injection reactions (PIRs) compared to Shingrix, specifically 12.5% for local PIRs and 27.5% for systemic PIRs for Z-1018 versus 52.6% and 63.2% for Shingrix, respectively [3][10] Group 2: Future Development Plans - Dynavax plans to advance Z-1018 into Part 2 of the Phase 1/2 trial targeting adults aged 70 and older, expected to start in the second half of 2025, using the 100 mcg dose of gE antigen with CpG 1018 and alum [1][7] - The objective of Part 2 is to generate clinical proof-of-concept against Shingrix in the older population, which is crucial for further development [4][7] Group 3: Market Potential - The company aims to disrupt the multi-billion-dollar shingles vaccine market, currently dominated by Shingrix, by developing a product with a potential best-in-class profile [4][5] - Z-1018 is designed to address the age-related decline in immune responses, providing a new option for protection against shingles, a disease affecting approximately 1 in 3 people in their lifetime [11][12]