SCB-2019 SARS-CoV-2 Vaccine Description
SCB-2019 is a novel TPOR agonist being developed to treat Immune Thrombocytopenia (ITP) and Chemo-Induced Thrombocytopenia（CIT). SCB-2019 is a recombinant subunit vaccine candidate targeted for the prevention of SARS-CoV-2 coronavirus that causes COVID-19 disease.
Clover Biopharmaceuticals patented Trimer-Tag© technology has produced an S-Trimer subunit vaccine candidate that resembles the native trimeric viral spike via mammalian cell-culture production system.
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) and enveloped RNA virus antigens responsible for entry into host cells.
Clover uses Trimer-Tag technology to create trimerized fusion proteins that can effectively target these previously undruggable pathways.
Sichuan (Clover) Biopharmaceuticals is a China-based, global, clinical-stage, a research-based biotechnology company focused on discovering, developing, and commercializing transformative biologic therapies, focusing on oncology and autoimmune diseases, as well as viral vaccines. Founded by a team of world-class scientists returning to China, Clover Biopharmaceuticals is passionate about developing transformative biologic therapies for the millions of Chinese patients who currently do not have access to modern biological medicines.
SCB-2019 SARS-CoV-2 Vaccine Indication
SCB-2019 is indicated to prevent infection from SARS-CoV-2. Each SCB-2019 dose level will be evaluated with and without adjuvant.
The study initiation follows promising preclinical results, which demonstrated the beneficial effect of GSKs pandemic adjuvant for the SCB-2019 vaccine candidate, with high neutralizing antibody levels elicited in multiple animal species.
The use of an adjuvant is of particular importance in a pandemic situation since it can reduce the amount of protein required per dose, allowing more vaccine doses to be produced and made available to more people.
SCB-2019 SARS-CoV-2 Vaccine News
July 8, 2020 - CEPI announced it would make an additional investment of $66m upfront in S-Trimer, which will immediately fund preclinical studies, the execution of Phase 1 clinical trials, and preparation of sites globally for an efficacy trial. In parallel, this investment will support the scale-up of Clover’s manufacturing capacity to potentially allow the production of hundreds of millions of doses per year.
June 19, 2020 - GSK’s scientific collaboration with Clover Pharmaceuticals to develop an adjuvanted COVID-19 vaccine has entered into human clinical trials. Clover announced the initiation of Phase 1 clinical study evaluating the company’s COVID-19 S-Trimer vaccine (SCB-2019) combined with GSKs pandemic adjuvant system.
June 19, 2020 - Clover Biopharmaceuticals became the sixth Chinese developer of a potential SARS-CoV-2 vaccine, SCB-2019, to move into human trials. Clover is launching a study in Australia that will test its vaccine with two different boosters provided by GSK and Dynavax. Preliminary safety and immunogenicity results for this Phase 1 study were expected in August 2020. In parallel, the planning for a global Phase 2b/3 vaccine efficacy trial has begun, with initiation targeted by year-end 2020.
April 27, 2020 – The Coalition for Epidemic Preparedness Innovations announced it would invest an initial US$3.5 million in a partnering agreement with Clover Biopharmaceuticals AUS Pty Ltd (“Clover Australia”) a wholly-owned subsidiary of Sichuan Clover Biopharmaceuticals, Inc (China) (“Clover Biopharmaceuticals”), bringing the organization’s total investment in COVID-19 vaccine research & development to US$39.6m.
SCB-2019 SARS-CoV-2 Vaccine Clinical Trials
Clinical Trial NCT04405908 - The phase 1 trial will enroll adult and elderly patients in Australia. The study is being conducted at Linear Clinical Research in Perth, Australia, and will enroll approximately 90 healthy adult participants and 60 healthy elderly participants. Preliminary safety and immunogenicity results for the Phase 1 study were expected in August 2020.
This is a randomized, double-blind, placebo-controlled, first-in-human (FIH) study to assess the safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels, administered as 2 injections IM in healthy subjects. Each study vaccine dose level will be evaluated with and without adjuvant.
In parallel, the planning for a global Phase 2b/3 vaccine efficacy trial has begun, with initiation targeted later in 2020.