First participants dosed in Phase I trial of SCB 2019 vaccine + TLT 9 for COVID-19. Dynavax + Clover Biopharmaceuticals.

Dynavax Technologies announced that the first participants have been dosed in the Phase I clinical trial to evaluate Clover Biopharmaceuticals’ vaccine candidate to prevent COVID-19 that contains the Company’s CpG 1018 adjuvant. In this previously announced collaboration, Clover is advancing its COVID-19 S-Trimer vaccine (SCB 2019), which is based on Clover’s proprietary Trimer-Tag vaccine technology platform, while Dynavax is providing the Company’s proprietary toll-like receptor 9 (TLR 9) agonist adjuvant, CpG 1018. The study is a Phase I randomized, double blind, placebo controlled, first-in-human (FIH) study to assess safety, reactogenicity, and immunogenicity of SCB 2019 at multiple dose levels, administered as 2 intramuscular (IM) injections in approximately 90 adult healthy subjects 18 to 54 years of age and approximately 60 elderly healthy subjects 55 to 75 years of age. The trial and Clover’s COVID-19 vaccine program are being supported by funding and collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). The Phase I study will evaluate SCB 2019 alone, SCB 2019 in combination with Dynavax’s CpG 1018 adjuvant combined with alum, and SCB 2019 in combination with a different adjuvant. Based on preclinical results demonstrating the ability of CpG 1018-adjuvanted SCB 2019 to elicit neutralizing antibodies in multiple animal species, the collaboration has been expanded to include clinical supply of CpG 1018 to Clover. Preliminary safety and immunogenicity results of the study are expected in August 2020.