INOVIO (NASDAQ: INO) has received approval from India’s Central Drugs Standard Control Organisation’s Drug Controller General of India to continue its phase 3 part for the global Phase2/3 INNOVATE study in India for the company’s DNA COVID-19 vaccine candidate INO-4800.
INOVIO collaborating with Advaccine on INNOVATE study
The company is collaborating with Advaccine Biopharmaceuticals Suzhou Co, ltd to carry out the Phase 3 segment of the study in several countries across Asia, Africa, and Latin America. The approval in India comes at the back of authorizations by health bodies of Columbia, Mexico, Brazil, and the Philippines.
INO-4800’s efficacy in a two-dose 2.0 mg per dosage regimen, administered one month apart, in 2-to-1 randomization in males and non-pregnant women 18 years of age and older will be evaluated in the global Phase 3 section of INNOVATE. Virologically verified symptomatic COVID-19 is the primary goal of this case-driven Phase 3 investigation.
INOVIO CEO J. Joseph Kim said, “As COVID-19 continues to threaten the health and safety of the global population, and many areas of the world are still awaiting sufficient access to safe and effective vaccines, INOVIO is pleased to receive regulatory authorization to proceed with our efficacy Phase 3 trial in India. INOVIO remains steadfast in its mission to fight COVID-19 through the development of INO-4800, which is designed to serve the needs of those in India and beyond, as both a primary series and a booster vaccine.”
INNOVATE Phase 2 study sponsored in the US
The study’s Phase 3 segment builds on the second phase segment conducted in the US and sponsored by the US Department Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense in conjunction with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency.
Preliminary phase 2 data from the study revealed in May 2021 in MedRxiv showed that INO-4800 was well tolerated and was immunogenic in adults above 18 years. Also, another study demonstrated that INO-4800 could offer a wide range of cross0reactive immune responses that include notable T cell responses and neutralizing antibodies against strains of concern.
