Inovio Resumes COVID-19 Vaccine Late-Stage Study

Inovio has received the FDA go-ahead for a phase 3 trial of INO-4800, a DNA plasmid vaccine against COVID-19.

The agency lifted a prior clinical hold on the study after Inovio satisfied questions about the vaccine and its needleless electroporation delivery system, Inovio’s Joseph Kim said on an investor webcast.

Inovio and partner Advaccine Biopharmaceuticals Suzhou Co. (China) will conduct the INNOVATE study in Mexico, Brazil, Columbia and Thailand, in addition to the U.S. The trial will evaluate INO-4800 in healthy adults aged 18 years and older, who will get two 2-mg doses given one month apart. The primary endpoint is virologically confirmed symptomatic COVID-19.

“We are aiming to have the interim phase 3 data available by the first half of 2022,” after which Inovio will apply for an Emergency Use Authorization, Kim said.