Dynavax and Clover to collaborate for Coronavirus (COVID-19) Vaccine

Dynavax and Clover Biopharmaceuticals have announced a research collaboration to evaluate Coronavirus (COVID-19) Vaccine Candidate with CpG 1018 Adjuvant.

US biopharmaceutical organisation Dynavax Technologies Corporation (Nasdaq: DVAX) will supply CpG 1018, the adjuvant used in the U.S. FDA-approved hepatitis B vaccine HEPLISAV-B, to help accelerate the development of a coronavirus (COVID-19) vaccine developed by China-headquartered Clover Biopharmaceuticals. Clover is advancing assessment of the nominee for coronavirus protein dependent vaccine candidate (COVID-19 S-Trimer) in preclinical studies.

Dynavax and Clover collaboration for COVID-19 vaccine development

Dynavax is committed to the production and promotion of new vaccines, and Sichuan-based Clover, a multinational clinical-stage biotechnology firm, is committed to the production of innovative biological therapies. Today, Dynavax and Clover announced that they have joined a scientific partnership to create a vaccine candidate for the prevention of COVID-19.

Clover’s protein-based candidate for a coronavirus vaccine (COVID-19 S-Trimer)

In preclinical trials, Clover is advancing evaluation of its protein-based candidate for a coronavirus vaccine (COVID-19 S-Trimer). To help this effort, Dynavax provides technological skills and the patented toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018.

Upon learning the genomic DNA sequence of the recently identified SARS-CoV-2 virus, which triggers the COVID-19 disease, Clover’s scientists started designing the viral spike (S)-protein development in late January 2020 and achieved its genome synthesis.

Using its proprietary Trimer-Tag © technology, Clover has developed a subunit vaccine candidate COVID-19 S-Trimer that matches the native trimeric viral spike via a rapid expression mechanism centred on mammalian cell-culture. Owning one of China’s biggest in-house, commercial-scale cGMP bioproduction capabilities in China, Clover could theoretically scale-up very quickly to manufacture large quantities of a new coronavirus vaccine.

Joshua Liang, Chief Strategy Officer at Clover and co-inventor of COVID-19 S-Trimer vaccine said:

“At Clover, we are eager to begin evaluating the combination of our S-Trimer vaccine candidate and Dynavax’s CpG 1018 adjuvant, as we believe adjuvants could play an important role in developing a successful and widely-available vaccine for this pandemic.”
“Leveraging our proprietary© Trimer-Tag technology, S-Trimer is being rapidly developed to support global efforts in combating the current and any future coronavirus outbreaks.”

Dynavax’s CpG 1018 adjuvant

CpG 1018 is the adjuvant used in the U.S. Food and Drug Administration (FDA) approved adult hepatitis B vaccine HEPLISAV-B ® [Hepatitis B Vaccine (Recombinant), Adjuvanted]. Dynavax developed CpG 1018 to have an improved immune response to the vaccine, which has been demonstrated in HEPLISAV-B.

CpG 1018 includes advanced technology and a significant safety database, possibly speeding up the development and manufacture of a COVID-19 vaccine on a global scale.

Ryan Spencer, Chief Executive Officer of Dynavax commented:

“Successfully responding to this public health emergency will require a collaborative approach, combining technologies and sharing data, to rapidly develop a vaccine to prevent COVID-19.”
“We are proud to contribute to this global effort with the goal of supporting rapid development and enabling large-scale manufacturing through the utilization of CpG 1018 which has already been successfully implemented in an approved, marketed vaccine in the U.S.”

About the COVID-19 S-Trimer Vaccine

S-Trimer is a trimeric nominee for the SARS-CoV-2 spike (S)-protein subunit vaccine, utilising Trimer-Tag © technology. SARS-CoV-2 is also an RNA virus which has a trimeric spike (S) protein on its viral shell, identical to other enveloped RNA viruses such as HIV, RSV, and Influenza.

The SARS-CoV-2 trimeric S protein is responsible for attaching to the host cell surface receptor ACE2 and resulting in viral entry making it the predominant target antigen for the production of vaccines. S-Trimer copies the protein from the native trimeric viral spike and is generated by a rapid expression mechanism based on mammalian cell culture.

More About Clover Biopharmaceuticals

China-based Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology corporation concentrating on the exploration, production and commercialization of innovative biological drugs, centred on oncology, autoimmune disorders, and viral vaccines. Having received over 100 million US dollars in overall capital since 2016, Clover is utilising its patented development system Trimer-Tag © to build novel biologics that target trimerisation-dependent pathways. In addition, Clover is using its biomanufacturing technologies in-house to produce select biosimilars. For more information please visit www.cloverbiopharma.com.

More About Dynavax

Dynavax is a biopharmaceutical corporation that develops and manufactures and markets new vaccines at a commercial level.

In February 2018, after the United States FDA approval, the company released its first commercial drug, HEPLISAV-B ® [Hepatitis B Vaccine (Recombinant), Adjuvanted] for infection prevention from all identified subtypes of the hepatitis B virus in individuals 18 years of age and over.

Via scientific alliances and partnerships, Dynavax also develops CpG 1018 as an innovative vaccine adjuvant. To know more, visit www.dynavax.com.