What's Happening?
Dynavax Technologies, a biotech company based in Emeryville, California, has announced promising results from a phase 1/2 clinical trial of its shingles vaccine candidate, Z-1018. The trial compared Z-1018 to GSK's Shingrix, a leading shingles vaccine with significant market share. The results showed that Z-1018 has comparable efficacy to Shingrix but with better tolerability. The study involved nearly 120 healthy participants aged 50 to 69 years, and the best performing dose of Z-1018 achieved a 100% antibody response, compared to 96.9% with Shingrix. Dynavax plans to proceed with a second stage of the study, focusing on a 100 mcg dose with its proprietary adjuvant CpG 1018 and alum, targeting an older age group of 70-plus. This stage is expected to begin before the end of the year and could lead to registration trials if successful.
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Why It's Important?
The development of a new shingles vaccine by Dynavax could significantly impact the multi-billion-dollar shingles vaccine market, currently dominated by GSK's Shingrix. With approximately 1 million cases of shingles annually in the U.S., there is a substantial demand for effective vaccines. Dynavax's Z-1018, with its strong immune response and favorable tolerability, could offer a competitive alternative to Shingrix, potentially improving patient outcomes and expanding vaccine options. The success of this vaccine could also enhance Dynavax's market position and drive innovation in vaccine development, particularly in addressing age-related immune decline.
What's Next?
Dynavax is set to advance to the next phase of clinical trials, focusing on an older demographic that is most at risk for shingles. If the results continue to be positive, the company will move towards registration trials, which are crucial for gaining regulatory approval. The outcome of these trials will be closely watched by stakeholders in the pharmaceutical industry, as well as healthcare providers and patients seeking new vaccination options. Additionally, other companies like Pfizer and BioNTech, which are developing mRNA-based shingles vaccines, may also influence the competitive landscape.
