$328 Million For China’s S-Trimer COVID-19 Vaccine Development
The Coalition for Epidemic Preparedness Innovations (CEPI) based in Norway announced that it will fund the development of the protein-based S-Trimer COVID-19 vaccine candidate being produced by Sichuan Clover Biopharmaceuticals, Inc.
CEPI stated on November 3, 2020, its total investment in Clover’s S-Trimer vaccine candidate (SCB-2019) 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 in China and globally, and initial manufacturing scale-up activities.
Clover added ‘promising preclinical and preliminary Phase 1 data will be published in a peer-reviewed publication in the near future, which will indicate that S-Trimer is well-tolerated and produces strong neutralizing antibody and Th1-biased cell-mediated immune responses. This information merits ongoing evaluation of the vaccine candidate.’
CEPI and Clover stated in this press release they ‘are committed to ensuring equitable global access to the S-Trimer vaccine, and the agreement, therefore, anticipates that vaccine output funded by CEPI’s investment – potentially hundreds of millions of doses per year – will be made available for procurement and allocation through the COVAX Facility.
The expanded partnership 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 of this vaccine candidate, the program 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.
Joshua Liang, CEO of Clover added: “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. 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.”
Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development. S-Trimer resembles the native trimeric viral spike protein and is produced via a rapid mammalian cell-culture based expression system.
Trimer-Tag is an innovative drug development platform that allows the production of novel, covalently-trimerized fusion proteins.
CEPI, alongside Gavi and the World Health Organisation, co-leads the vaccines pillar of the ACT Accelerator – known as COVAX – which is working to accelerate research and development for promising vaccine candidates, manufacture doses at scale, and ensure rapid global access.
CEPI opened a Representative Office in Shanghai in April 2020. Through its Shanghai Representative Office, CEPI is seeking to cooperate broadly in China on COVID-19 vaccine development and build robust collaborations to prevent and control other potential infectious disease outbreaks in the future.
Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing, and commercializing transformative biologic therapies.
PrecisionVaccinations publishes research-based vaccine development news.