By the end of 2021, the terms of a new supply agreement will see Dynavax Technologies Corporation deliver its CpG 1018 adjuvant to Clover Biopharmaceuticals for use in its COVID-19 vaccine candidate, SCB-2019.
SCB-2019 is a protein-based vaccine that, pending regulatory approvals, is expected to launch by the end of 2021. The new commercial supply arrangement assists this by providing doses of adjuvant through the end of 2022. Those supplies have already been manufactured as part of a previous funding agreement between the Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax.
“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,” Joshua Liang, CEO of Clover Biopharmaceuticals, said. “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.”
Separately, Clover signed an advanced purchase agreement with Gavi, the Vaccine Alliance, to supply up to 414 million doses of its vaccine candidate through 2022 for use by the global equitable distribution effort known as the COVAX Facility. A global Phase 2/3 clinical trial to determine the efficacy, safety, and immunogenicity of SCB-2019 is ongoing, with interim data expected later this year. Applications for regulatory approval abroad would then begin.
“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,” Dynavax CEO Ryan Spencer said. “We are proud to support the ongoing development and the potential near-term commercialization of SCB-2019 (CpG 1018/Alum).”