Dynavax Technologies Corporation (NASDAQ:DVAX) announced topline results from Part 1 of its randomized, observer-blinded, and active-controlled Phase 1/2 clinical trial of Z-1018, a shingles vaccine candidate, head-to-head versus Shingrix in participants aged 50 to 69 years on Thursday.
In Part 1 of the trial, at one month after the second vaccine dose, Z-1018 demonstrated antibody and CD4⁺ T cell vaccine responses similar to those observed in the comparator arm receiving GSK Plc’s (NYSE:GSK) Shingrix, the currently licensed shingles vaccine, with a favorable tolerability profile. In the second quarter of 2025, Shingrix sales reached 853 million pounds, up 3% year-over-year.
At the dose formulation and regimen chosen for advancing to Part 2 of the trial, Z-1018 achieved a 100.0% humoral vaccine response rate (antibody production) compared to Shingrix at 96.9%, and an 89.7% cellular immune vaccine response rate (CD4+ T-cell response) compared to Shingrix at 93.5%, resulting in a composite vaccine response rate of 89.7% for the Z-1018 group and 90.3% for Shingrix.
Z-1018 was also well-tolerated with a favorable safety profile in the study. Z-1018 exhibited low rates of grade 2 and 3 solicited local and systemic post-injection reactions (PIRs) in all dose, formulation, and dosing regimen arms.
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At the dose formulation and regimen chosen for advancement to Part 2 of the trial, 12.5% of participants receiving Z-1018 reported grade 2 or 3 local PIRs, and 27.5% reported grade 2 or 3 systemic PIRs, compared to 52.6% and 63.2% for Shingrix, respectively.
No safety concerns have been identified in this ongoing blinded study.
Z-1018 is an investigational shingles vaccine utilizing the Dynavax-manufactured glycoprotein E (gE) antigen and is adjuvanted with CpG 1018, Dynavax’s proprietary vaccine adjuvant.
"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," Dynavax CEO Ryan Spencer said in a statement on Thursday.
Based on these results, Dynavax intends to advance Z-1018 into Part 2 of the Phase 1/2 program in adults 70 and older, which is expected to initiate in the second half of 2025.
Based on these results, Dynavax has selected the 100 mcg dose of gE antigen, adjuvanted with CpG 1018 and alum, and using an 8-week dosing interval, to advance into Part 2 of the Phase 1/2 trial.
This study will evaluate adults aged 70 and older to generate clinical proof-of-concept head-to-head versus Shingrix in this key population, ahead of advancing into the pivotal program.
Dynavax reported second-quarter earnings of 14 cents, beating the consensus of 9 cents per share, with sales of $91.87 million, beating the consensus of $85.91 million.
Price Action: DVAX stock is up 8.78% at $11.34 at the last check on Thursday.
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