Dynavax Technologies Corporation ( 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 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 ( DVAX )-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 ( DVAX ) CEO Ryan Spencer said in a statement on Thursday.

Based on these results, Dynavax ( DVAX ) 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 ( DVAX ) 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 ( DVAX ) 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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