Dynavax Highlights 2022 Priorities and Announces Initiation of Phase 1 Clinical Trial for Its Shingles Vaccine Candidate
"The transformative increase in value we saw in 2021 resulted from the strategic realignment of our company to focus on vaccines, driving growth in HEPLISAV-B® and advancing our CpG 1018® adjuvant supply strategy with a diverse portfolio of COVID-19 vaccine developers," said
Strategic Priorities to Drive Long-term Growth
Maximize Growth of HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]
- Recently upgraded recommendations from the
CDC's Advisory Committee on Immunization Practicesadvise that all adults aged 19-59 be vaccinated against Hepatitis-B, creating a significantly expanded market opportunity which the company estimates to be $800 millionin the U.S.by 2027. The Company believes that HEPLISAV-B is well-positioned to secure majority market share.
- With a proven clinical profile and strong commercial execution, the Company expects further market share gains and revenue growth in 2022.
Expand CpG 1018 Adjuvant Supply Business for COVID-19 Vaccines
- Recent Phase 3 clinical data from partnered programs consistently demonstrated the value of CpG 1018 adjuvant across multiple vaccine platforms.
- Additional regulatory authorization for partners' COVID-19 vaccines anticipated in the first half of 2022.
Dynavaxcontinues to expand manufacturing capacity to meet our partners' needs for adjuvant in 2022 and beyond.
Drive Innovation Through Clinical Pipeline Expansion and Discovery
- Topline data is expected in the first half of 2022 from the Company's ongoing Tdap-1018 phase 1 clinical trial evaluating the safety, tolerability, and immunogenicity in adults with adolescent data expected in the second half of 2022.
- Topline data from a phase 1 clinical trial evaluating the safety, tolerability, and immunogenicity of the Company's investigational shingles vaccine candidate adjuvanted with CpG 1018 is expected by the end of 2022.
- In collaboration with, and fully funded by, the
U.S. Department of Defense, the company will conduct a phase 2 clinical trial for a plague vaccine adjuvanted with CpG 1018 which is anticipated to initiate in the second half of 2022.
- Further advancement of product candidates with CpG 1018 adjuvant through pre-clinical and clinical collaborations and additional discovery efforts, including ongoing partnership with
Mount Sinaiinvestigating universal and seasonal influenza.
CpG 1018 Adjuvanted Shingles (Herpes Zoster) Vaccine Candidate Enters the Clinic
Shingles is an extremely painful consequence of the reactivation of a latent varicella zoster virus infection, with attacks leading to potential complications including chronic pain. The current shingles vaccine market is approximately
"Our CpG 1018 adjuvant has an established tolerability profile demonstrated in a wide range of clinical trials and real-world, commercial use," commented
CpG 1018 adjuvant has demonstrated its ability to enhance the immune response without excessive reactogenicity in both HEPLISAV-B and multiple COVID-19 clinical trials. Importantly, CpG 1018 has shown the ability to generate high levels of CD4+ t-cells which have been demonstrated to be key cell types in controlling latent VZV infection to avoid reactivation leading to shingles. The global phase 1 study is designed to evaluate safety, tolerability and immunogenicity of the vaccine candidate which is comprised of glycoprotein E (gE) plus CpG 1018 adjuvant. Data from this trial is expected to be available by the end of 2022.
This press release contains "forward-looking" statements, including statements regarding expected or anticipated financial performance, including market share, revenue and profitability, potential U.S. market for hepatitis vaccines, establishing CpG 1018 as a leading adjuvant, the development and potential approval of vaccines containing CpG 1018 by us or by our collaborators, potential market size and future sales of CpG 1018 or HEPLISAV-B or other product candidates, the timing of initiation and completion of clinical studies and the publication of results, the timing of our collaborators seeking conditional, emergency use or full authorization of COVID-19 vaccines containing CpG 1018 adjuvant, our ability to scale manufacturing capacity, our efforts to develop an improved pertussis and shingles vaccine, our collaboration partners' efforts to develop and commercialize a vaccine for COVID-19, entering into strategic relationships and expected results of such relationships and the potential for CpG 1018 to accelerate development and large scale manufacturing of COVID-19 or other vaccines. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that HEPLISAV-B may not become the standard of care adult hepatitis B vaccine in the
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