Dynavax Technologies is a biopharmaceutical company focused on developing and commercializing innovative vaccines aimed at preventing infectious diseases. Central to their approach is the use of proven adjuvant technology, specifically the CpG 1018 adjuvant, which enhances the immune response to vaccines. Their flagship product, HEPLISAV-B, is a two-dose hepatitis B vaccine that utilizes this adjuvant to improve immunogenicity and safety compared to traditional vaccines. The company has successfully launched HEPLISAV-B in the U.S. and Europe, and it is actively involved in various clinical trials to expand its vaccine pipeline, including candidates for tetanus/diphtheria/pertussis and herpes zoster.

The company’s commitment to advancing vaccine technology is reflected in its ongoing research and development efforts, which are supported by collaborations with organizations such as the U.S. Department of Defense. Dynavax emphasizes the importance of clinical trials in bringing new vaccines to market, relying on volunteer participation to evaluate the safety and efficacy of their investigational products. Their scientific contributions have been recognized in peer-reviewed publications, showcasing the effectiveness of their adjuvant technology in enhancing immune responses across different vaccine candidates.

United States

Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body’s innate and adaptive immune responses through Toll-like Receptor (TLR) stimulation. Dynavax develops, and commercializes novel vaccines.

Digestive System Diseases

Infectious Diseases

Dynavax Technologies

COVID-19

MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax plus aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by U.S. NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). &nbsp;Building upon the S-2P platform, MVC conducted large-scale &nbsp;screenings of various adjuvants and finalized the compositions of &nbsp;MVC-COV1901 vaccine to optimize safety and desired immunogenicity &nbsp;properties. MVC established the production platform of MVC-COV1901 and &nbsp;based on MVC's preclinical and phase 1 clinical study data, MVC-COV1901 &nbsp;showed robust safety and promising immunogenicity responses and as a &nbsp;result entered Phase 2 clinical trial in 2020.

MVC-COV1901

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 increases antibody concentrations, stimulates helper (CD4+) and cytotoxic (CD8+) T cell populations and generates robust T and B cell memory responses.
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.
Combining COVID-19 surface antigens with CpG 1018 for the vaccine to elicit a higher antibody titer.&nbsp;
(<a href="https://www.dynavax.com/science/cpg-1018/">Source</a>)

CpG 1018

Hepatitis B

Hepatitis B vaccine

Infectious disease

Unlike traditional 3-dose vaccines that use an alum adjuvant with no specific cellular response, HEPLISAV-B combines a yeast-derived recombinant hepatitis B surface antigen (HBsAg) with the proprietary adjuvant, 1018, to activate Toll-like receptor 9 (TLR9) expressed on first-responder immune cells for direct immune stimulation.
The proprietary antigen is taken up by the TLR9-expressing antigen-presenting cell to trigger a cascade of robust immunostimulatory responses. This may induce a highly specific, helper T-cell response to generate memory T and B cells.

Heplisav-B

Utilizing Clover's proprietary Trimer-Tag© technology, &nbsp;S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit COVID vaccine candidate. Similar to other enveloped RNA viruses such as HIV, RSV and &nbsp;Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) &nbsp;protein on its viral envelope. The trimeric S protein of SARS-CoV-2 is &nbsp;responsible for binding to host cell surface receptor ACE2 and &nbsp;subsequent viral entry, making it the primary target antigen for vaccine &nbsp;development. S-Trimer resembles the native trimeric viral spike protein &nbsp;and is produced via a rapid mammalian cell-culture based expression &nbsp;system. S-Trimer is intended to be adjuvanted.
SCB-2019 is a recombinant subunit vaccine candidate for COVID-19.&nbsp; Utilizing our patented Trimer-Tag© technology, Clover has produced a S-Trimer subunit vaccine candidate that resembles the native trimeric viral spike via mammalian cell-culture production system.

COVID-19 S-Trimer (with Clover Biopharmaceuticals)

Plague

(rF1V) vaccine (adjuvanted w/ CpG 1018)

Shingles

Viral infection

Z-1018 (adjuvanted w/ CpG 1018)

VLA2001 is Valneva’s COVID vaccine candidate against the SARS-CoV-2 virus. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high Spike protein (S-protein) density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the cellular immune response towards Th1. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. The process, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S protein. CpG 1018 is a component of the US FDA-approved HEPLISAV-B® vaccine.VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).
 
Adjuvant: 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 increases antibody concentrations, stimulates helper (CD4+) and cytotoxic (CD8+) T cell populations and generates robust T and B cell memory responses. Additionally, CpG 1018 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 provides a well‑developed technology and a significant safety database, potentially accelerating the development of novel vaccines.

Dynavax Technologies

Company Details