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Clover Biopharma completes enrollment in SPECTRA phase 2/3 trial of Covid-19 vaccine candidate, SCB-2019

Chengdu, China
Wednesday, July 7, 2021, 15:00 Hrs  [IST]

Clover Biopharmaceuticals, a global clinical-stage biotechnology company, announced the completion of targeted enrollment of adult and elderly participants in SPECTRA (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted Covid-19 Vaccine), a global pivotal phase 2/3 clinical trial evaluating the efficacy, safety and immunogenicity of SCB-2019 (CpG 1018/Alum), and Clover’s Covid-19 vaccine candidate.

SPECTRA is a double-blind, randomized, controlled study of SCB-2019 (CpG 1018/Alum) administered in a two-dose regimen, 21 days apart. Global enrollment surpassed 29,000 adult and elderly participants resulting in one of the most ethnically diverse Covid-19 clinical trials conducted to date, including over 45% of participants from Asia, 45% from Latin America and the remainder from Europe and Africa. Given the geographic diversity of SPECTRA, Clover expects to announce a robust dataset in Q3 2021 including an analysis of efficacy across the major currently circulating strains of SARS-CoV-2 (including variants of concern and variants of interest).

Pending positive data from SPECTRA, Clover plans to submit conditional regulatory approval applications to the NMPA, the EMA and WHO thereafter. Clover continues to plan to commence product launch of SCB-2019 (CpG 1018/Alum) by the end of 2021 and recently signed an advance purchase agreement with Gavi committing up to 414 million doses to the COVAX Facility. Clover also expects to supply doses to countries directly via government procurement and/or bilateral supply agreements.

“SPECTRA is the result of unprecedented cross-border collaboration across four continents and we extend our deepest gratitude to all of the participants, the investigators and our partners for their ongoing support in achieving this momentous event,” stated Joshua Liang, chief executive officer of Clover Biopharmaceuticals. “Covid-19 continues to impact many countries, and vaccine shortages continue to be a global challenge. We remain committed to the completion of SPECTRA, engaging with regulators, and making our Covid-19 vaccine candidate available to populations in need around the world.”

SCB-2019 (CpG 1018/Alum), Clover's Covid-19 vaccine candidate, is anticipated to potentially be one of the first protein-based Covid-19 vaccines commercialized globally through the COVAX Facility. Employing the Trimer-Tag technology platform, Clover developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein (S-Trimer) based on the original strain of the SARS-CoV-2 virus. Clover's Covid-19 vaccine candidate is the combination of SCB-2019 and two adjuvants, Dynavax's CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

Clover is currently advancing SPECTRA, a global pivotal phase 2/3 clinical trial evaluating the efficacy, safety, and immunogenicity of SCB-2019 (CpG 1018/Alum) and expects vaccine efficacy data in the third quarter of 2021. Pending positive data, Clover plans to submit conditional regulatory approval applications to the EMA, the NMPA and the WHO in the second half of 2021, and plans to commence product launch by the end of 2021.

 

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