Company: DVAX
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001029142-25-000071
Chunk: 250

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 1
Chunk 250
---
N1 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 trial.

Lyme Disease Vaccine Program:

We are developing an investigational multivalent protein subunit vaccine for the prevention of Lyme disease, a bacterial infection that is the most common vector-borne illness in the Northern Hemisphere.

•There are currently no approved human vaccines for Lyme disease and current vaccine candidates in clinical development require three-dose primary series and annual boosters. We believe our investigational Lyme disease vaccine adjuvanted with CpG 1018, which has a demonstrated ability to amplify immune response and improve durability of protection, has the potential for a differentiated and best-in-class vaccine profile. 

•Our Lyme disease vaccine candidate has progressed into Investigational New Drug (IND)-enabling studies, with plans to initiate clinical development in 2027.

29

Table of Contents

HEPLISAV-B for Adults on Hemodialysis:

We are developing a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis.

•We plan to conduct an observational retrospective cohort study to support its sBLA filing for a HEPLISAV-B vaccine regimen for adults on hemodialysis. In the first quarter of 2025