Company: DVAX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001628280-25-049536
Chunk: 253

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 1
Chunk 253
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 all doses and formulations evaluated in Part 1 of the trial, Z-1018 was well-tolerated and demonstrated a favorable tolerability profile, including lower solicited local and systemic post-injection reactions, versus Shingrix®. Z-1018 demonstrated robust immune responses in all dose arms, including a 100% humoral vaccine response rate at the dose selected for advancement, with comparable immunogenicity to Shingrix. 

•In October 2025, we announced that the first participants have been dosed in Part 2 of the Phase 1/2 trial evaluating Z-1018 head-to-head versus Shingrix in adults aged 70 years and older.  

•In support of establishing clinical proof-of-concept for Z-1018 as a differentiated, best-in-class shingles vaccine, we anticipate reporting both topline Part 2 results, along with 12-month follow-up data for Part 1, in the second half of 2026. 

Plague Vaccine Program:

We are developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018® in collaboration with, and fully funded by, the U.S. Department of Defense (DoD).

•In the fourth quarter of 2024, we and the DoD executed an agreement for approximately $30.0 million through the first half of 2027 to support additional clinical and manufacturing activities.

•In the third quarter of 2025, we executed an amendment to the agreement for approximately $14.0 million from the DoD to support additional non-human primate studies.

•We initiated Part 1 of the Phase 2 clinical trial evaluating the plague vaccine candidate and completed enrollment in the third quarter of 2025.

Pandemic Influenza Adjuvant Program:

We are evaluating CpG 1018 in an adjuvanted H5N1 influenza vaccine as a proof-of-concept for its potential use with pandemic influenza vaccines.

•During the second quarter of 2025, we completed Part 1 of the randomized, active-controlled Phase 1/2 study to evaluate the safety and immunogenicity of an investigational H5N1 influenza vaccine adjuvanted with CpG 1018 in 101 participants aged 18 to 49.  

•Based on the results from Part 1 of the study, we are advancing the optimal formulation of CpG 1018 adjuvant to evaluate in Part 2 of the Phase 1/2