Company: DVAX
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001029142-25-000071
Chunk: 297

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 8
Chunk 297
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 Part 1, and we anticipate reporting top-line immunogenicity and safety data in the third quarter of 2025.

•We plan to advance the selected vaccine formulation and regimen from Part 1 into a Part 2 of the Phase 1/2 study in adults over age 70 years to generate clinical proof-of-concept in this key population, with key end points including tolerability and immunogenicity comparisons to Shingrix, ahead of advancement into a pivotal trial.

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 a new agreement for approximately $30 million through the first half of 2027 to support additional clinical and manufacturing activities, including a Phase 2 clinical trial expected to initiate 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

•Pandemic influenza remains one of the most persistent and unpredictable global health threats. Vaccine adjuvants play an essential role in pandemic preparedness, mostly due to their dose sparing capability, yet despite their critical importance, the global supply of proven adjuvants remains limited.

•Leveraging our expertise and capabilities as a global supplier of CpG 1018 adjuvant for the development of multiple COVID-19 vaccines, we intend to generate clinical proof-of-concept for CpG 1018-adjuvanted pandemic influenza vaccines to support the potential commercial supply of vaccine adjuvant needed for global pandemic preparedness and response efforts. 

•In the second quarter of 2025, we expect to initiate a randomized, active-controlled Phase 1/2 study to evaluate the safety and immunogenicity of an investigational H5N1 influenza vaccine adjuvanted with CpG 1018.

•In Part 1 of the Phase 1/2 trial, we expect to enroll approximately 98 participants aged 18 to 49 years to receive either single-dose or two-dose formulations of the investigational vaccine, with the intention to select the optimal formulations of CpG 1018 adjuvant for Part 2 of the Phase 1/2