Clover Biopharmaceuticals began phase 1 clinical trials in Perth, Australia, on its COVID-19 vaccine candidate, which is supported by the Coalition for Epidemic Preparedness Innovations (CEPI).
CEPI has provided up to $3.5 million for Clover to support the preparation and initiation of a trial with its protein-based candidate vaccine. For the Clover trial, 150 human volunteers are expected to be enrolled to test the safety and immunogenicity of its COVID-19 S-Trimer subunit vaccine candidate. The Phase 1 trial will also evaluate two adjuvants, produced by Dynavax and CEPI partner GSK, that look to enhance the immune response and reduce the amount of antigen needed per vaccine dose.
“Last week’s developments are indicative of the incredible and rapid work being undertaken by our partners, which is unprecedented in the field of vaccine development. We still have a long way to go, but with this level of collaboration and innovation, we are continuing to move as quickly as possible in the hope that we can reduce the time needed to bring an end to this devastating crisis,” CEPI CEO Richard Hatchett said.
Preliminary results are expected in August 2020. CEPI’s goal is to have at least three vaccine candidates that could be submitted to regulatory authorities for licensure within an accelerated 12-18 month period. Clover Biopharmaceuticals can rapidly scale-up the production of the vaccine using its in-house biomanufacturing facilities.
Clover is now the fifth CEPI-funded vaccine candidate to start clinical testing. The others are Moderna, Novavax, University of Oxford and AstraZeneca, and Inovio. Recently, CEPI partner CureVac received regulatory approval for its COVID-19 vaccine candidate. On June 17, CureVac received regulatory approval from German and Belgian authorities to initiate Phase 1 clinical trials of its mRNA COVID-19 vaccine candidate.
In building its portfolio of vaccine candidates, CEPI has focused on candidates that have the potential to be developed at speed, at scale, and made globally accessible.