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Clover Biopharmaceuticals plans to initiate a global Phase II/III efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum in the first half of 2021.

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Published:2nd Feb 2021
Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company committed to developing transformative biologics as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation , a biopharmaceutical company focused on developing and commercializing vaccines, announced the plan to initiate a global Phase II/III efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to support the development of Clover's COVID-19 vaccine candidate and will fund the development, including the Phase II/III trial, through licensure. In its Phase 1 clinical trial, Clover's protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline plc both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles. Clover expects to produce hundreds of millions of vaccine doses in 2021 and up to 1 billion vaccine doses in peak annual production as required by global demand. Ryan Spencer, Chief Executive Officer of Dynavax, commented, "We are excited to be rapidly progressing to an efficacy trial to support filing for emergency use and approval. Clover's S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response." Clover and GSK also decided to discontinue their partnership to evaluate the S-Trimer COVID-19 vaccine candidate with GSK's pandemic adjuvant system. The companies all remain united in their missions to maximize their contributions to ending the current pandemic. All parties remain confident that their respective strategies and collaborations for COVID-19 vaccine development will be able to maximize their respective and overall impacts against the COVID-19 pandemic.
Condition: Coronavirus/COVID-19 Infection
Type: drug

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