With ‘promising’ preliminary safety and immunogenicity results from the Phase I clinical study, Clover aims to expand its current 2 x 2000 L capacity of the Cytiva FlexFactory, which went into service in January 2020
Cytiva is supporting Clover Biopharmaceuticals to help accelerate the development and manufacturing of a protein-based S-Trimer subunit vaccine candidate.
Cytiva will help Clover add two more 2000 L bioreactors for a total of 4 x 2000 L manufacturing capacity through the Cytiva FlexFactory, which will include process equipment, services, and consumables to ensure safety, efficiency, scaled-up capacity for vaccine development. This will meet Clover's Phase II/III clinical production plan and commercial readiness once its vaccine candidate is approved.
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. The vaccine candidate is recognised by antibodies produced by previously-infected patients, Clover says, indicating it may elicit a protective-immune response.
Clover's Phase I 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 I dose-expansion study at a selected S-Trimer dose-level. The company intends to initiate a global Phase II/III 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 anticipates the vaccine will be made available for procurement and allocation through the COVAX Facility to those who need it most around the world.
Peng Liang, founder and Chief Scientific Officer of Clover, said: "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 VP of Cytiva Asia Pacific, said: "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."