Dynavax Unveils Positive Phase 1/2 Results for Innovative Shingles Vaccine Z-1018

Positive Phase 1/2 Results for Z-1018 Shingles Vaccine

Dynavax Technologies Corporation recently announced encouraging topline results from Part 1 of its Phase 1/2 clinical trial for Z-1018, an innovative shingles vaccine. This study involved healthy participants aged between 50 to 69 years and compared the safety, tolerability, and immunogenicity of Z-1018 against Shingrix, the currently licensed shingles vaccine. The results highlighted the potential of Z-1018 being a game-changer in the multi-billion-dollar shingles vaccine market.

In the Phase 1/2 trial conducted by Dynavax, Z-1018 demonstrated a robust immune response, achieving a 100% vaccination response rate with antibody production, while Shingrix recorded a 96.9% response rate. Moreover, when it came to CD4⁺ T-cell responses, Z-1018 maintained an 89.7% response rate, closely trailing Shingrix's 93.5%. The favorable results from the trial reinforce the vaccine’s potential as a leading contender in the vaccine landscape.

One of the most impressive aspects of Z-1018's research was its tolerability. Unlike the current market leader Shingrix, which has been associated with significant post-injection reactions, Z-1018 exhibited low rates of grade 2 and 3 local and systemic reactions. In this study, only 12.5% of participants experienced grade 2 or 3 local reactions, while 27.5% reported systemic reactions. In stark contrast, Shingrix had 52.6% and 63.2% respectively, showcasing Z-1018's improved safety profile.

The CEO of Dynavax, Ryan Spencer, emphasized the importance of these findings, suggesting that they could potentially disrupt the existing shingles vaccine market currently dominated by Shingrix. “These positive data mark an important inflection point for our vaccine program as we develop a product aiming for a best-in-class profile,” Spencer stated.

The study’s design involved various dose formulations and regimens, focusing on three different dose levels of glycoprotein E—that is, 50 mcg, 100 mcg, and 200 mcg—combined with two types of adjuvants, one being Dynavax’s proprietary CpG 1018. The outcomes indicate that the selected formulation and dose—the 100 mcg dose administered with CpG 1018 and alum—has presented the best immunogenic response and tolerability.

With its favorable results, Dynavax has set the stage for Part 2 of the Phase 1/2 trial, which will focus on older adults aged 70 and above. This demographic is crucial to target, as they are more susceptible to shingles due to the natural decline in immune responses with age. The clinical proof-of-concept study is expected to commence in the second half of 2025 and aims to further evaluate Z-1018's effectiveness versus Shingrix in this older population.

Shingles, caused by the reactivation of the varicella-zoster virus, affects roughly one in three adults at some point in their lives, leading to significant pain and potential complications particularly in the elderly. Despite available vaccinations, the demand for a more tolerable and effective solution persists.

In summary, Dynavax's Phase 1/2 results for Z-1018 have positioned the company as a frontrunner in developing a new shingles vaccine. As the clinical trials progress, there is cautious optimism that Z-1018 could provide a stronger immune response with fewer side effects over the current options available in the market.