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Investing.com -- Dynavax Technologies Corporation (NASDAQ:DVAX) stock soared 8% Thursday after the company announced positive topline results from its Phase 1/2 clinical trial for Z-1018, its experimental shingles vaccine candidate.
The trial demonstrated that Z-1018 achieved comparable immune responses to GlaxoSmithKline (NYSE:GSK)’s Shingrix, the current market-leading shingles vaccine, while showing a significantly better tolerability profile. At the selected dose formulation, Z-1018 achieved a 100% humoral vaccine response rate compared to 96.9% for Shingrix.
Notably, Z-1018 exhibited substantially lower rates of adverse reactions. Only 12.5% of participants receiving Z-1018 reported grade 2 or 3 local post-injection reactions and 27.5% reported grade 2 or 3 systemic reactions, compared to 52.6% and 63.2% for Shingrix, respectively.
"These positive data mark an important inflection point for our novel shingles vaccine program as we strive to develop a product with a potential best-in-class profile with the aim to disrupt the multi-billion-dollar shingles vaccine market, which is currently dominated by one product," said Ryan Spencer, Chief Executive Officer of Dynavax.
Based on these results, Dynavax has selected the 100 mcg dose of glycoprotein E antigen, adjuvanted with CpG 1018 and alum, using an 8-week dosing interval, to advance into Part 2 of the trial. This next phase will evaluate adults 70 years and older, with initiation expected in the second half of 2025.
The company’s Z-1018 vaccine utilizes Dynavax’s proprietary CpG 1018 adjuvant, which is already used in its FDA-approved hepatitis B vaccine, HEPLISAV-B.
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