Sichuan Clover Biopharma announced the Coalition for Epidemic Preparedness Innovations (CEPI) will underwrite clinical development of its protein-based S-Trimer COVID-19 vaccine with up to $328 million in backing. CEPI has already granted $69.5 million of the total to Clover for preclinical studies, Phase I clinical trials and set-up for the global Phase II/III trials and manufacturing scale up. In the Phase I trial, the vaccine was found to be safe and effective, though Clover has not yet released detailed data from the test.

Clover did say the vaccine produced "promising preclinical and preliminary Phase 1 data," indicating the S-Trimer is well-tolerated and produces strong neutralizing antibody and Th1-biased cell-mediated immune responses. Clover plans to publish data from the Phase I trial in a journal.

The company expects to start the Phase II/III trial before the end of 2020. It will also fund additional clinical studies in specific populations, including people with autoimmune conditions, immunocompromised individuals, pregnant women and children.

While the trial is underway, Clover will continue scaling up the manufacturing process with a goal of producing over one billion doses annually. The company expects to have a large inventory available for use by the time its vaccine is approved. Clover hopes to commercialize the vaccine in China and globally.

Dr Richard Hatchett, CEO of CEPI said, “The clinical development and manufacturing progress of Clover’s S-Trimer vaccine candidate are very promising so far, so I am pleased to extend our partnership with Clover through to potential licensure of the vaccine.”

Joshua Liang, CEO of Clover said, “We are honored to receive CEPI’s continued investment which is based on months of close collaboration and early preclinical, manufacturing scale-up, and clinical success in the development of a safe and efficacious vaccine for COVID-19.”

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Disclosure: none.