Clover’s Final SPECTRA Phase 2/3 Clinical Trial Efficacy Data Is Published in The Lancet
CHENGDU, China, Jan. 21, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced that final efficacy data from SPECTRA, a global Phase 2/3 clinical trial evaluating the efficacy, safety, and immunogenicity of its COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), has been published in the peer-reviewed journal, The Lancet. The paper, ‘Efficacy of the adjuvanted subunit protein Covid-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial,’ may be accessed here.
SCB-2019 (CpG 1018/Alum) achieved the primary efficacy endpoint and secondary efficacy endpoints. The COVID-19 vaccine candidate also demonstrated 100% efficacy against severe COVID-19 and hospitalization caused by any strain of SARS-CoV-2 in SPECTRA. SCB-2019 (CpG 1018/Alum) showed a favorable safety profile with no significant differences observed in systemic adverse events or severe adverse events when compared to placebo.
“We are pleased to have the SPECTRA pivotal Phase 2/3 trial results for Clover’s COVID-19 vaccine candidate peer-reviewed and selected for publication in The Lancet,” stated Dr. Ralf Clemens, Chairman of the Vaccine Scientific Advisory Board of Clover Biopharmaceuticals. “SCB-2019 (CpG 1018/Alum) demonstrated high efficacy in an environment where all of the sequenced strains were variants, and no cases of the original SARS-CoV-2 strain were observed. Combined with a favorable safety and reactogenicity profile, Clover’s vaccine candidate utilizing well-established protein-based technology may help to overcome vaccine hesitancy and also warrants its further evaluation as a potential universal COVID-19 booster vaccine. Clover remains committed to making SCB-2019 (CpG 1018/Alum) available as quickly as possible to populations in need around the world.”
Clover is in the process of submitting conditional regulatory approval applications to the NMPA, EMA and the WHO and plans to commence product launch post conditional approval.
Trials are currently ongoing to evaluate SCB-2019 (CpG 1018/Alum) as a universal COVID-19 booster vaccine. In January 2022, the SPECTRA trial was amended and began evaluating SCB-2019 (CpG 1018/Alum) as a homologous booster in approximately 4,000 adult participants. In November 2021, a Phase 2 investigator-led trial was initiated in Brazil to evaluate SCB-2019 (CpG 1018/Alum) as a booster dose in people previously vaccinated with CoronaVac (inactivated COVID-19 vaccine) or recombinant COVID-19 vaccine (AstraZeneca/Fiocruz). Initial results from these trials, including immunogenicity against the Omicron variant, are anticipated in the first half of 2022.
About SCB-2019 (CpG 1018/Alum)
SCB-2019 (CpG 1018/Alum), our 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 (referred to as S-Trimer™) based on the original strain of the SARS-CoV-2 virus. Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavax’s CpG 1018 advanced adjuvant and aluminum hydroxide (alum).
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates. The Trimer-Tag™ technology platform is a product development platform for the creation of novel vaccines and biologic therapies. Clover leveraged the Trimer-Tag™ technology platform to become a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to address the COVID-19 pandemic caused by SARS-CoV-2.
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