Inovio Initiates Phase 1 Trial of COVID-19 Vaccine
Inovio announced yesterday that the FDA signed off on the company’s investigational NDA for its COVID-19 vaccine candidate INO-4800, clearing the way for a clinical trial.
The phase 1 trial will enroll up to 40 healthy adult volunteers in Philadelphia and Kansas City, Mo. Each participant will receive two doses of INO-4800 four weeks apart. Initial immune response and safety data are expected by late summer.
The company has manufactured thousands of doses to support phase 1 and phase 2 clinical trials and it plans to have 1 million doses of the vaccine available by the end of the year for additional trials and emergency use.
In January, the Coalition for Epidemic Preparedness Innovations (CEPI) awarded Inovio $9 million to support preclinical and clinical development of the potential vaccine (DID, Jan. 28). — Jordan Williams