The Coalition for Epidemic Preparedness Innovations (CEPI) has extended a partnership with Sichuan Clover Biopharmaceuticals, Inc. (Clover) to include funding for a global phase 2/3 efficacy clinical trial and licensure of its S-Trimer COVID-19 vaccine candidate.
S-Trimer is a protein-based vaccine previously funded by CEPI. The coalition assisted it with $69.5 million meant to get it through preclinical studies and phase one clinical trials. After this latest expansion of assistance, CEPI’s total investment in the candidate will be up to $328 million. As a result of that investment, the drug will be made available for procurement and allocation through the COVAX Facility, a global initiative to procure and distribute 2 billion doses of COVID-19 vaccine by the end of 2021.
“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,” CEPI CEO Richard Hatchett said. “CEPI’s expanded investment will fund critical late-stage clinical trials to establish the efficacy of the vaccine, in parallel to scaling up the manufacturing process with the goal of making potentially hundreds of millions of doses of this vaccine available to those who need it through COVAX, if it is proven to be safe and effective.”
The investment was made following promising preclinical and preliminary data from phase one, which indicated S-Trimer was well-tolerated and produced strong neutralizing antibodies and immune responses. The phase 2/3 trial will focus on safety and efficacy data that would allow it to gain licensure. That trial should begin before the end of the year.
Additional studies for special populations such as those with autoimmune conditions, immunocompromised individuals, pregnant women, and children will also be funded. At the same time, manufacturing will be scaled up to allow for the production of more than 1 billion doses annually.
“We look forward to continuing our partnership with CEPI as we stay committed to developing a safe and efficacious vaccine for communities in need around the globe,” Joshua Liang, CEO of Clover Biopharmaceuticals, said.