DCGI approves Ph 3 trial of Inovio’s DNA vaccine candidate for COVID-19

US-based Inovio Pharma has received authorisation from the Central Drugs Standard Control Organisation (CDSCO)’s Drug Controller General of India (DCGI) to proceed with the Phase 3 segment of INOVIO’s global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), in India for INO-4800, its DNA vaccine candidate for COVID-19. Inovio is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) to conduct the INNOVATE Phase 3 segment in multiple countries in Latin America, Asia, and Africa. Regulatory authorisation in India follows authorisations from health authorities in Brazil, the Philippines, Mexico and Colombia. As one of the only nucleic-acid based vaccines that is stable at room temperature for more than a year, at 37°C for more than a month, has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage, INO-4800 is anticipated to be wellpositioned for a primary series immunization as well as a booster.