The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to provide up to $328m to Clover Biopharmaceuticals for the development of Covid-19 vaccine candidate.
Clover will use the funding to conduct the global pivotal phase 2/3 efficacy clinical trial of the protein-based S-Trimer Covid-19 vaccine candidate. It will also use the funds to get a licence for the vaccine in China and across the globe.
The investment also includes earlier announced commitments of $69.5m, which have been used for studies and Phase 1 clinical trials, preparations for the global pivotal phase 2/3 efficacy study, and initial manufacturing scale-up activities.
S-Trimer, which uses advanced Trimer-Tag technology, is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. S-Trimer is generated through a rapid mammalian cell-culture based expression system.
The expanded partnership of CEPI is based on Clover’s successful early-stage clinical development of the S-Trimer vaccine candidate.
The funding will be used for a global pivotal phase 2/3 efficacy clinical trial of S-Trimer, which is expected to commence by the end of this year. Data from the trial will be used to secure a licence for the vaccine candidate.
Clover will also use funds to conduct additional clinical studies in special populations such as people with autoimmune conditions, immunocompromised individuals, pregnant women and children.
The programme will also focus on scaling up the manufacturing process to facilitate the production of more than one billion doses per annum, in parallel to the clinical development process.
After proving to be safe, S-Trimer vaccine will be provided through the COVAX Facility, a global initiative that helps to procure and distribute two billion doses of Covid-19 vaccine by the end of 2021.
CEPI CEO Dr Richard Hatchett said: “The clinical development and manufacturing progress of Clover’s S-Trimer vaccine candidate are very promising so far, so I am pleased to extend our partnership with Clover through to potential licensure of the vaccine.”
In February this year, GlaxoSmithKline (GSK) collaborated with Chinese firm Clover Biopharmaceuticals to assess coronavirus vaccine candidate with the pandemic adjuvant system.