Clover and Dynavax announce commercial supply agreement

Chinese clinical-stage biotech Clover Biopharmaceuticals and Nasdaq-listed Dynavax Technologies Corp, a biopharmaceutical company focused on developing and commercializing novel vaccines, announced on Wednesday 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 the Coalition for Epidemic Preparedness Innovations and Dynavax.

Clover separately announced on Wednesday 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.

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 European Medicines Agency, China's National Medical Products Administration and the World Health Organization in the second half of 2021. It also plans to commence product launch by the end of 2021.