- The Coalition for Epidemic Preparedness Innovations (CEPI) and Vaxxinity Inc (NASDAQ:VAXX) will co-fund the ongoing global Phase 3 trial of Vaxxinity's next-generation UB-612 COVID-19 vaccine candidate.
- The candidate is under development as a heterologous – or 'mix-and-match' – booster dose.
- CEPI will provide up to $9.25 million in funding.
- The Phase 3 trial, which began in the US earlier this year, is evaluating UB-612 to boost COVID-19 immunity against the original strain and multiple variants.
- The trial includes people aged 16 years or older who have been previously immunized with an authorized COVID-19 vaccine.
- Approximately 1,000 healthy adults will participate in the Vaxxinity-sponsored multi-center international trial.
- The primary immunogenicity analyses will be available in 2H of 2022.
- If successful, the study may support conditional approval of UB-612, as discussed with global regulators.
- UB-612 is the first multitope subunit protein/peptide-based vaccine candidate for SARS-CoV-2, which is designed to activate the immune system's B and T-cell arms.
- Phase 1 and Phase 2 trials of UB-612 conducted in ~4000 participants have shown UB-612 to be well tolerated with no vaccine-related serious adverse events.
- Price Action: VAXX shares closed 5.02% lower at $4.35 on Wednesday.
