Company: DVAX
Filing Date: 2025-02-20
Form Type: 10-K
Source: 0001029142-25-000049
Chunk: 11

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-02-20
Form: 10-K
Item: Item 1
Chunk 11
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 evaluating the safety, tolerability, and immunogenicity in adults. At four weeks following the 2-dose regimen, the investigational shingles vaccine Z-1018 demonstrated high antibody and CD4+ T-cell vaccine response rates in all arms, which were similar to the licensed comparator. Robust increases in CD4+ T-cells were observed in all Z-1018 arms, although lower than the comparator. Total frequency of solicited systemic adverse events and local post-injection reactions and moderate and severe reactions were similar across the Z-1018 arms and lower than the comparator. 

In June 2023, we presented results from the Phase 1 trial at the National Foundation for Infectious Diseases’ 2023 Annual Conference on Vaccinology Research. These results demonstrate the opportunity to develop a shingles vaccine with improved vaccine tolerability and comparable efficacy to Shingrix and support the continued development of our shingles vaccine candidate. We received Type B meeting feedback from the FDA on the Z-1018 clinical development plan and submitted an IND to the FDA to support the initiation of a Phase 1/2 trial of Z-1018, upon IND clearance, in the first half of 2024. 

In June 2024, we initiated a Phase 1/2 clinical trial evaluating the safety, tolerability, and immunogenicity of Z-1018. Enrollment in the Phase 1/2 randomized, active-controlled, dose escalation, multicenter trial was completed in 2024, with approximately 440 healthy adults aged 50 to 69 years enrolled at trial sites in Australia. The trial will evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix. Key objectives of the trial include selecting the optimal glycoprotein E (gE) protein dose level and dosing schedule for further clinical development. The Phase 1/2 trial will be used to support validation of a Patient Reported Outcome measurement tool to differentiate Z-1018 on tolerability and to support potential label claims. We anticipate reporting top line immunogenicity and safety data in the third quarter of 2025.

Tdap Vaccine Program

In June 2017, we entered into an agreement with Serum Institute of India Pvt. Ltd. ("SIIPL") to collaborate on development and commercialization of certain potential vaccines including Tdap booster adjuvated with CpG 1018. Under the collaboration, we have exclusive worldwide rights to commercialize the vaccine, except that SIIPL