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Dynavax Highlights Positive Data and Next Steps for Shingles Vaccine Z-1018

During a recent session at IDWeek 2025, Dynavax Technologies Corporation (Nasdaq: DVAX) revealed encouraging topline results from the initial part of its Phase 1/2 trial assessing Z-1018, a new shingles vaccine candidate. This meeting not only showcased their innovative progress in vaccine development but also announced the commencement of Part 2 of the trial, specifically focusing on adults aged 70 and older.

Understanding Z-1018 and Its Significance

Shingles, medically known as herpes zoster, is a painful condition caused by the reactivation of the varicella-zoster virus. Statistically, around one third of individuals will encounter this illness during their life, often with severe complications, particularly among the elderly. Despite established vaccines such as Shingrix®, the medical community acknowledges a continuous need for improved access and tolerability in shingles prevention.

Z-1018 aims to answer this need. It is a recombinant subunit vaccine incorporating gE antigens and refined with Dynavax's proprietary adjuvant, CpG 1018, along with alum. This combination is hypothesized to counteract the immune response decline that naturally occurs with age, thus better serving adults over 50 years.

Clinical Trial Details

Part 1 of the clinical trial was structured as a randomized, observer-blinded, active-controlled study aimed at determining the safety and immunogenicity of three varying doses of gE antigen (50 mcg, 100 mcg, and 200 mcg) alongside two distinct adjuvant formulations. These dosages were administered through varying intervals of eight and twelve weeks.

The primary goal was to evaluate the immunogenic responses, gauging factors such as:

• - Vaccine response rates (VRRs) for anti-gE IgG antibodies
• - The frequency of gE-specific CD4+ T-cells in subjects aged 50-69

Results were promising, revealing that the Z-1018 formulation adjuvanted with CpG 1018 demonstrated not only a favorable response rate but also robust safety and tolerability across studied dosage levels. Moreover, a significant proportion of participants elicited polyfunctional CD4+ T-cell responses, signifying a broad and effective cellular immune reaction.

Advancements Towards Part 2 of the Trial

Dynavax has now initiated Part 2 of the Phase 1/2 study, aiming to involve approximately 324 healthy adults aged 70 and above. This segment of the trial will be conducted across various sites in Australia and New Zealand. The study is designed to further assess the immunogenicity and safety profile of Z-1018 while ensuring non-inferiority compared to Shingrix on critical immunogenicity endpoints.

Dr. Robert Janssen, Dynavax's Chief Medical Officer, expressed optimism regarding these developments, emphasizing their commitment to advancing Z-1018 towards clinical application. He stated, “Our belief that Z-1018 can achieve outstanding performance is reinforced with this data, particularly in this vulnerable age group.”

Expected updates regarding the immunogenicity and safety data from Part 2 are anticipated in the latter half of 2026.

Future Directions

The unveiling of these phase results marks a significant step towards ensuring effective vaccination strategies for shingles, especially in older adults who are the most susceptible to the virus. With the innovative approach undertaken by Dynavax through Z-1018, the potential exists not only for enhanced protection against shingles but also for providing a viable option with improved tolerability. As the healthcare community watches closely, Z-1018 could redefine standards in shingles prevention and treatment moving forward.

For further insights into Dynavax's product offerings and research initiatives, interested parties can visit Dynavax's official website.