The Coalition for Epidemic Preparedness Innovations, an innovative partnership launched at Davos in 2017 between public, private, philanthropic and civil organizations to develop vaccines to stop future epidemics, announced Tuesday that it will fund the development of the protein-based S-Trimer COVID-19 vaccine candidate by China's Sichuan Clover Biopharmaceuticals Inc through to licensure, including a global pivotal Phase 2/3 efficacy clinical study beginning before the end of 2020, if the vaccine is proven to be safe and effective.
The coalition'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.
Clover said it is exploring development pathways for the S-Trimer vaccine to be made accessible to populations in China and globally, if it is proven to be safe and effective.
The company and the coalition are committed to ensuring equitable global access to the S-Trimer vaccine, and the agreement anticipates vaccine output funded by the coalition's investment – potentially hundreds of millions of doses per year – will be available for procurement and allocation through the COVAX Facility, which is a global initiative that aims to procure and fairly distribute 2 billion doses of COVID-19 vaccine by the end of 2021, to help protect the most at-risk groups in all participating countries.
The expanded partnership is a result of Clover's successful early stage clinical development of the S-Trimer vaccine candidate.
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, Clover said in a press release.
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 program will continue scaling up the manufacturing process to potentially allow the production of more than 1 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, the company said.