Benzinga | Jan 10, 2022 08:06AM EST

Dynavax Announces Initiation Of Phase 1 Clinical Trial For Its Shingles Vaccine Candidate

Dynavax Technologies Corporation (NASDAQ:DVAX), a commercial stage biopharmaceutical company focused on developing and commercializing innovative vaccines, today outlined its strategic priorities for 2022, and announced the newest candidate in its clinical development portfolio -- a herpes zoster virus (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(r) and advancing our CpG 1018(r) adjuvant supply strategy with a diverse portfolio of COVID-19 vaccine developers," said Ryan Spencer, Chief Executive Officer of Dynavax. "We anticipate continued product revenue growth in 2022 which will further enable investment in our clinical pipeline leveraging our proven adjuvant technology and help fuel our vision to build a leading vaccine company."

Strategic Priorities to Drive Long-term Growth

Dynavax anticipates continued profitability in 2022 driven by its CpG 1018 adjuvant supply business for COVID-19 vaccines and increasing HEPLISAV-B sales. To help achieve its long-term growth strategy, the Company's strategic priorities for 2022 include:

Maximize Growth of HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

* Recently upgraded recommendations from the CDC's Advisory Committee on Immunization Practices advise that all adults aged 19-59 be vaccinated against Hepatitis-B, creating a significantly expanded market opportunity which the company estimates to be $800 million in 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.

* Dynavax continues 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 Sinai investigating 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 $2 billion and expected to grow over time.

"Our CpG 1018 adjuvant has an established tolerability profile demonstrated in a wide range of clinical trials and real-world, commercial use," commented Rob Janssen, Chief Medical Officer of Dynavax. "We therefore believe it is the ideal adjuvant to maintain high levels of efficacy with significantly less reactogenicity resulting in an improved shingles vaccine."

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.