Dynavax outlines its priorities for 2022 and announces the launch of a phase 1 clinical trial for its shingles vaccine candidate
EMERYVILLE, California.Jan. 10, 2022 / PRNewswire / – Dynavax Technologies Company (Nasdaq: DVAX), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative vaccines, today outlined its strategic priorities for 2022 and announced the new candidate in its clinical development portfolio – a vaccine candidate against the herpes zoster virus (shingles).
“The transformative increase in value we saw in 2021 is a result of the strategic realignment of our business to focus on vaccines, driving the growth of HEPLISAV-B® and advancing our CpG 1018 adjuvant sourcing strategy ® with a diverse portfolio of COVID-19 vaccine developers, “mentioned Ryan spencer, Managing Director of Dynavax. “We anticipate continued product revenue growth in 2022, which will allow further investment in our clinical pipeline by leveraging our proven adjuvant technology and help fuel our vision of building a leading vaccine company. ”
Strategic priorities to drive long-term growth
Dynavax expects continued profitability in 2022 through its business of supplying CpG 1018 adjuvants for COVID-19 vaccines and increased sales of HEPLISAV-B. To help it achieve its long-term growth strategy, the Company’s strategic priorities for 2022 include:
Maximize the growth of HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]
- The recently updated CDC Advisory Committee on Immunization Practices recommendations advise that all adults aged 19 to 59 be vaccinated against hepatitis B, creating a vastly expanded market opportunity that the company believes to be. $ 800 million in the United States by 2027. The Company believes that HEPLISAV-B is well positioned to achieve majority market share.
- With a proven clinical profile and strong business execution, the Company expects further market share gains and revenue growth in 2022.
To expand CpG 1018 adjuvant supply business for COVID-19 vaccines
- Recent Phase 3 clinical data from partner programs has consistently demonstrated the value of CpG 1018 adjuvant across multiple vaccine platforms.
- Additional regulatory clearance for partners’ COVID-19 vaccines expected in the first half of 2022.
- Dynavax continues to expand its manufacturing capacity to meet the admixture needs of our partners in 2022 and beyond.
Drive innovation through expansion and discovery of clinical pipelines
- First data expected in the first half of 2022 of the company’s ongoing Phase 1 Tdap-1018 clinical trial evaluating safety, tolerability and immunogenicity in adults with adolescent data expected in the second half of 2022 .
- The first data from a phase 1 clinical trial evaluating the safety, tolerability and immunogenicity of the Company’s investigational vaccine candidate against herpes zoster with CpG 1018 adjuvant is expected by the end of 2022.
- In collaboration with, and fully funded by, the US Department of Defense, the company will conduct a Phase 2 clinical trial for an adjuvanted plague vaccine with CpG 1018 scheduled to start in the second half of 2022.
- Further advancement of product candidates with adjuvant CpG 1018 through preclinical and clinical collaborations and additional discovery efforts, including an ongoing partnership with Mount Sinai to investigate universal and seasonal influenza.
CpG 1018 adjuvanted shingles (herpes zoster) candidate enters clinic
Shingles is an extremely painful consequence of reactivation of a latent infection with the varicella-zoster virus, with attacks leading to potential complications, including chronic pain. The current shingles vaccine market is approximately $ 2 billion and should grow over time.
“Our adjuvant CpG 1018 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 that it is the ideal adjuvant to maintain high levels of efficacy with significantly less reactogenicity, which makes it possible to improve the herpes zoster vaccine.”
CpG 1018 adjuvant has been shown to enhance the immune response without excessive reactogenicity in multiple HEPLISAV-B and COVID-19 clinical trials. Importantly, CpG 1018 has shown the ability to generate high levels of CD4 + t cells which have been shown to be key cell types in controlling latent VZV infection in order to avoid reactivation leading to shingles. The global phase 1 study is designed to assess the safety, tolerability and immunogenicity of a vaccine candidate that includes glycoprotein E (gE) plus adjuvant CpG 1018. Data from this trial are expected to be available by now the end of 2022.
Dynavax is a commercial-stage biopharmaceutical company that develops and markets new vaccines to help protect the world against infectious diseases. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the United States and the European Union for the prevention of infections caused by all known subtypes of the hepatitis B virus in adults 18 years of age and older. Dynavax is also advancing CpG 1018 adjuvant as the first vaccine adjuvant through collaborations and research partnerships. Current collaborations focus on adjuvanted vaccines for COVID-19, plague, Tdap, seasonal influenza, and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.
This press release contains “forward-looking” statements, including statements regarding expected or anticipated financial performance, including market share, revenues and profitability, the potential US hepatitis vaccine market, establishing the CpG 1018 as a leading adjuvant, the development and potential approval of vaccines containing CpG 1018 by us or our associates, the potential market size and future sales of CpG 1018 or HEPLISAV-B or other product candidates , when to initiate and complete clinical studies and when results are published, when our collaborators research conditions, emergency use or full authorization of COVID-19 vaccines containing the adjuvant CpG 1018, our ability to increase manufacturing capacity, our efforts to develop an improved vaccine against pertussis and herpes zoster, the efforts of our partners in c working together to develop and commercialize a vaccine for COVID-19, forge strategic relationships and the expected results of those relationships and the powerful ial for CpG 1018 to accelerate the development and large-scale manufacture of COVID-19 or other vaccines. Actual results may differ materially from those presented in this press release due to the risks and uncertainties inherent in our business, including the risk that HEPLISAV-B may not become the gold standard for adult hepatitis B vaccine in the States. United, the risks associated with whether and when prescribers and other key decision makers of potential purchasing entities will make the decision to switch to HEPLISAV-B, and the timing and quantity of actual purchases, the risks associated with when and ” impact of ACIP’s universal recommendation on hepatitis B, risks related to the timing of completion and the results of ongoing clinical studies conducted by us or our collaborators, the risks that our collaborators do not obtain the approval of their vaccine candidates, the risks associated with the development and preclinical and clinical testing of vaccines containing the adjuvant CpG 1018, and whether the use of CpG 1018 will prove beneficial in these vaccines, the risks associated with whether, when and how much CpG 1018 is being purchased by vaccine manufacturers, the risks associated with using contract manufacturers to deliver CpG 1018 in a timely manner and the financial commitments made to them, as well as other risks detailed in the “Risk Factors” and “Management’s Discussion of Financial Position and Results of Operations” sections of our quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2021 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other material factors in our other filings with the United States Securities and Exchange Commission. We assume no obligation to revise or update the information contained in this document to reflect future events or circumstances, even if new information becomes available.
Information on Dynavax’s website at www.dynavax.com is not incorporated by reference into our current periodic relationship with the SEC.
Nicole arndt, Investor Relations
Derek cole, President
Investor Relations Consulting Solutions
SOURCE Dynavax Technologies