Cytiva supports Clover Biopharmaceuticals to scale up the output of its vaccine candidate
SHANGHAI: Cytiva, a global life sciences leader, is supporting Clover Biopharmaceuticals, a global clinical-stage biotechnology company, to help accelerate the development and manufacturing of a protein-based S-Trimer subunit vaccine candidate. With promising preliminary safety and immunogenicity results from the Phase 1 clinical study, Clover aims to quickly expand its current 2 x 2000L capacity of the Cytiva FlexFactory, which went into service in January 2020.
Cytiva will help Clover add two more 2000L bioreactors for a total of 4 x 2000L manufacturing capacity through the Cytiva FlexFactory, which will provide a total solution including process equipment, services, and consumables to ensure safety, efficiency, scaled-up capacity for vaccine development. In addition, this will meet Clover’s Phase 2/3 clinical production plan and commercial readiness once its vaccine candidate is approved.
Peng Liang, Founder and Chief Scientific Officer of Clover and inventor of the Trimer-Tag© technology, says, “A successful vaccine that can truly modulate the course of the COVID-19 pandemic must have four essential characteristics: safety, efficacy, scalability of manufacturing, and speed. Our continued work with Cytiva, using large scale single-use technology, will ensure that billions of doses of the advanced COVID-19 subunit vaccine could be produced once ready for commercial launch in 2021.”
Francis Van Parys, Commercial Vice President of Cytiva Asia Pacific, adds, “Developing vaccines to fight the COVID-19 pandemic is a mission to protect life and human health. With our advanced, proven track record in meeting global regulatory requirements and quality standards, the Cytiva team will work with Clover to accelerate the development and manufacturing scale-up for the vaccine candidate to ensure its full accessibility when it is ready to go to market.”
Clover’s COVID-19 S-Trimer vaccine was developed by combining the trimeric SARS-CoV-2 spike (S)-protein with the company’s proprietary Trimer-Tag© technology. As the first company in the world to produce a COVID-19 vaccine candidate that is successfully recognized by antibodies produced by previously-infected patients, Clover demonstrates that S-Trimer has preserved the native structure of the viral spike (S) protein and thus may elicit a protective-immune response as a vaccine.
Clover’s Phase 1 clinical study has completed enrollment of 150 adult and elderly participants. Based on positive preliminary results, an additional 280 participants will be enrolled in a Phase 1 dose-expansion study at a selected S-Trimer dose-level. The company intends to initiate a global Phase 2/3 vaccine efficacy study before the end of 2020.
The clinical trials and Clover’s COVID-19 vaccine program are supported by funding and collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). The agreement between CEPI and Clover anticipates that the vaccine – if proven to be safe and effective – will be made available for procurement and allocation through the COVAX Facility to those who need it most around the world.