SCB-2019 COVID-19 Vaccine Description
SCB-2019 COVID-19 vaccine candidate was developed by combining the trimeric SARS-CoV-2 spike (S)-protein with the company’s proprietary Trimer-Tag© technology.
Trimer-Tag is an innovative drug development platform that allows the production of novel, covalently-trimerized fusion proteins. Many major disease targets are trimerization-dependent such as the tumor necrosis factor (TNF) superfamily (involved in extrinsic apoptosis, immune co-stimulation, and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells.
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.
The protein-based SCB-2019 COVID-19 vaccine candidate in combination with adjuvants from either GSK or Dynavax induces a strong immune response and protection against SARS-CoV-2 in animal models.
Preclinical data as shown Clover’s protein-based adjuvanted COVID-19 vaccine candidate, S-Trimer, induces a strong neutralizing immune response in animals and protects nonhuman primates from a SARS-CoV-2 challenge. And strong immune response and protection were observed with adjuvant systems from GSK and Dynavax.
These positive preclinical data supported the decision to progress adjuvanted vaccine candidates using both adjuvants into Clover’s ongoing Phase 1 clinical study of S-Trimer in healthy adult and elderly participants, said the company on September 25, 2020.
Clover Biopharmaceuticals is a global clinical-stage biotechnology company focused on discovering and developing transformative biologic therapies and vaccines.
SCB-2019 COVID-19 Vaccine Indication
SCB-2019 COVID-19 is indicated to prevent SARS-CoV-2 infection which causes COVID-19 disease
SCB-2019 COVID-19 Vaccine News
September 25, 2020 - Clover Biopharmaceuticals Announces Positive Preclinical Data and Updates on Phase 1 Study for its Adjuvanted S-Trimer COVID-19 Vaccine Candidate.
July 8, 2020 - The Coalition for Epidemic Preparedness Innovations announced the expansion of its partnership with Sichuan Clover Biopharmaceuticals, Inc. to rapidly advance the development and manufacture of Clover’s protein-based COVID-19 S-Trimer vaccine candidate, which is based on Clover’s proprietary Trimer-Tag© vaccine technology platform.
SCB-2019 COVID-19 Vaccine Clinical Trials
Clinical Trial NCT04405908: SCB-2019 as COVID-19 Vaccine
- This is a 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 injections IM in healthy subjects.
- In June 2020, Clover announced the start of a Phase 1 clinical trial. The trial is a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine at multiple dose levels.
- The study has completed enrollment of 150 adult and elderly participants. Preliminary results show that the vaccine is likely to be safe and well-tolerated, with high levels of neutralizing antibodies observed. Based on these preliminary results, an additional 200 participants will be enrolled in a Phase 1 dose-expansion study at the selected S-Trimer dose-level and adjuvanted with either GSK’s pandemic adjuvant or Dynavax’s advanced adjuvant CpG 1018 plus alum.
- Clover intends to initiate a global Phase 2/3 vaccine efficacy study before the end of 2020. Detailed Phase 1 data will be made available in a peer-reviewed publication in the near future. The clinical trials and Clover’s COVID-19 vaccine program are being supported by funding and collaboration with the Coalition for Epidemic Preparedness Innovations.