prnasiaJune 30, 2021
Tag: Clover , Dynavax , SCB-2019
Clover Biopharmaceuticals, a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates to address the world's most life-threatening diseases and public health threats, and Dynavax Technologies Corporation, a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the execution of a commercial supply agreement of Dynavax's CpG 1018TM advanced adjuvant, for use in Clover's protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). The commercial supply agreement extends to the end of 2022. The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax.
Clover separately announced today an advanced purchase agreement with Gavi, the Vaccine Alliance, for supplying up to 414 million doses of SCB-2019 (CpG 1018/Alum) through 2022 for the COVAX Facility. The COVAX Facility is a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines, regardless of income level. Pending conditional regulatory approvals, Clover expects to commence product launch of SCB-2019 (CpG 1018/Alum) by the end of 2021, supplying the COVAX Facility and countries directly via government procurement and/or bilateral supply agreements.
"Throughout the development of our COVID-19 vaccine candidate, Dynavax has been an invaluable partner with a shared goal of maximizing our collective impacts in fighting the unprecedented COVID-19 pandemic. We look forward to the continued partnership as we accelerate large-scale production of SCB-2019 (CpG 1018/Alum) for potential commercial supply to communities in need around the globe," stated Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals.
Ryan Spencer, Chief Executive Officer of Dynavax commented, "Dynavax is excited for the opportunity to expand our partnership with Clover into an important commercial supply agreement to provide significant amounts of CpG 1018 for combatting the ongoing pandemic. We are proud to support the ongoing development and the potential near-term commercialization of SCB-2019 (CpG 1018/Alum)."
SCB-2019 (CpG 1018/Alum), Clover's COVID-19 vaccine candidate, is anticipated to be one of the first commercialized protein-based COVID-19 vaccines 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 interim data for vaccine efficacy around the middle of 2021. Pending positive interim 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.
Clover Biopharmaceuticals is a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates to address the world's most life-threatening diseases and public health threats. The Trimer-Tag© technology platform is a product development platform for the creation of novel vaccines and biologic therapies. We have leveraged the Trimer-Tag© technology platform to become a COVID-19 vaccine developer and potentially one of the first companies to commercialize a protein-based COVID-19 vaccine globally through the COVAX Facility.
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