Dynavax Announces First Participants Dosed in Phase 1 Clinical Trial Evaluating Clover Biopharmaceuticals’ COVID-19 S-Trimer Vaccine Candidate with CpG 1018 Adjuvant
- Preclinical results demonstrated the ability of CpG 1018-adjuvanted SCB-2019 to elicit neutralizing antibodies in multiple animal species
- Clover expects to enroll 150 healthy adult and elderly participants in the Phase 1 study
- Preliminary safety and immunogenicity results expected in
August 2020 Dynavax is providing CpG 1018, the adjuvant contained in itsU.S. FDA-approved adult hepatitis B vaccine, to enhance the immune response of Clover’s COVID-19 vaccine
In this previously announced collaboration, Clover is advancing its COVID-19 S-Trimer vaccine (SCB-2019), which is based on Clover’s proprietary Trimer-Tag© vaccine technology platform, while
“We are proud to contribute CpG 1018 to this global effort to rapidly develop an adjuvanted vaccine to prevent COVID-19,” commented
The study is a Phase 1 randomized, double blind, placebo controlled, first-in-human (FIH) study to assess safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels, administered as 2 intramuscular (IM) injections in approximately 90 adult healthy subjects 18 to 54 years of age and approximately 60 elderly healthy subjects 55 to 75 years of age. The trial and Clover’s COVID-19 vaccine program are being supported by funding and collaboration with the
The Phase 1 study will evaluate SCB-2019 alone, SCB-2019 in combination with Dynavax’s CpG 1018 adjuvant combined with alum, and SCB-2019 in combination with a different adjuvant. Based on preclinical results demonstrating the ability of CpG 1018-adjuvanted SCB-2019 to elicit neutralizing antibodies in multiple animal species, the collaboration has been expanded to include clinical supply of CpG 1018 to Clover. Preliminary safety and immunogenicity results of the study are expected in
About the Novel Coronavirus SARS-CoV-2 (and COVID-19 Disease)
SARS-CoV-2 is a new coronavirus identified in late 2019 which belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus causes a disease named COVID-19. Since this outbreak was first reported in late 2019, the virus has infected over 8.2 million people and has caused over 445,000 reported deaths (as of
About COVID-19 S-Trimer Vaccine
Utilizing Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development. S-Trimer resembles the native trimeric viral spike protein and is produced via a rapid mammalian cell-culture based expression system.
About Clover Biopharmaceuticals
About Vaccine Adjuvants
An adjuvant is a pharmacological or immunological agent that modifies the effect of other agents. Adjuvants are added to a vaccine to boost the immune response to produce more antibodies and longer-lasting immunity, thus minimizing the dose of antigen needed. Adjuvants may also be used to enhance the efficacy of a vaccine by helping to modify the immune response by particular types of immune system cells.
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the
About
Forward-Looking Statements
This press release contains "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine and to do so on an accelerated basis. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of completing development, when clinical trial results will be obtained and what they will demonstrate, whether and when the vaccine will be approved for use, and whether the Company will be able to manufacture sufficient quantities of CpG 1018 to meet demand, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended
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Source: Dynavax Technologies Corporation