CEPI, the Coalition for Epidemic Preparedness Innovations, will fund the development of the protein-based S-Trimer COVID-19 vaccine candidate by Sichuan Clover Biopharmaceuticals through a global pivotal Phase 2/3 efficacy clinical trial and to licensure in China and globally, if the vaccine is proven to be safe and effective.
CEPI’s total investment in Clover’s S-Trimer vaccine candidate will be up to $328 million, including previously announced commitments of $69.5 million which have funded preclinical studies and Phase 1 clinical trials, preparations for the global pivotal Phase 2/3 efficacy study, and initial manufacturing scale-up activities.
Promising preclinical and preliminary Phase 1 data – which will be published in a peer-reviewed publication in the near future – indicate that S-Trimer is well-tolerated and produces strong neutralizing antibody and Th1-biased cell-mediated immune responses, which merit ongoing evaluation of the vaccine candidate.
The expanded partnership is a result of Clover’s successful early stage clinical development of the S-Trimer vaccine candidate.
It will provide full funding for a global pivotal Phase 2/3 efficacy clinical trial of S-Trimer which is expected to begin before the end of 2020 and aims to generate the necessary safety and efficacy data to support licensure of the vaccine candidate.
It will also fund additional clinical studies in special populations, such as people with autoimmune conditions, immunocompromised individuals, pregnant women and children.
In parallel to the clinical development process, the programme will continue scaling up the manufacturing process to potentially allow the production of more than one billion doses annually, and build up vaccine inventory which – if the vaccine is proven to be safe and effective – could be deployed rapidly upon licensure.
“This expanded partnership enables Clover to advance our S-Trimer vaccine candidate into a global Phase 2/3 efficacy study by the end of this year and subsequently to Chinese and global licensure in 2021,” said Joshua Liang, CEO of Clover Biopharmaceuticals.