CpG 1018 adjuvant is Dynavax’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant contained in HEPLISAV-B®, the Company’s U.S. FDA-approved hepatitis B vaccine.
Adjuvants are a pharmacological or immunological substance that is combined with a specific protein (antigen) in a vaccine to help stimulate an immune response against the antigen. Some adjuvants work by stimulating specific immune pathways, such as toll like receptor 9 (TLR9), that promote stronger immune responses than with antigens alone. Others tend to stimulate multiple immune pathways. Adjuvants are typically used in vaccines where an antigen from a virus is not sufficient on its own to generate a protective immune response. Adjuvants are used with the aim to generate faster, stronger and longer-lasting protective vaccine responses.
CpG 1018® has been studied clinically and developed as a vaccine adjuvant for Dynavax’s hepatitis B vaccine, HEPLISAV-B. The pre-clinical and clinical studies demonstrate that the addition of CpG 1018 adjuvant increases antibody concentrations, stimulates helper (CD4+) and cytotoxic (CD8+) T cell populations and generates robust T and B cell memory responses.
Additionally, CpG 1018 adjuvant strongly favors development of the Th1 subset of helper T cells, the type of helper T cell that is essential for protection from infections with viruses and intracellular bacteria. CpG 1018® targets a single, well defined receptor (TLR9) expressed on only a few key cell types and the mechanisms of action as an adjuvant are quite well understood.
CpG 1018 adjuvant provides a well‑developed technology and a significant safety database, potentially accelerating the development of novel vaccines.
Based on the prior successful use of CpG 1018 adjuvant in vaccine clinical development and regulatory approval, Dynavax is making the adjuvant available to select research institutions and partners globally, to support development of adjuvanted vaccines using CpG 1018®.
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