INO-4800 is an advanced prophylactic DNA vaccine candidate, designed to work against the activity of SARS-CoV-2, the virus that causes Covid-19
Inovio, a biotechnology company focused on DNA therapies, has dosed the first subject in a Phase 2 study evaluating its Covid-19 vaccine candidate INO-4800, as part of the Phase 2/3 INNOVATE clinical trial programme.
INNOVATE (INovio INO-4800 Vaccine Trial for Efficacy) is a randomised, blinded, placebo-controlled clinical trial, designed to evaluate the safety and efficacy of INO-4800, administered in adults in the US.
INO-4800 is the company’s advanced prophylactic DNA vaccine candidate, developed to work against the activity of SARS-CoV-2, the virus that causes Covid-19.
The company said that its INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not need to be frozen during transport or storage, which are important considerations when preparing for mass immunizations.
INOVIO president and CEO J Joseph Kim said: “We’re pleased to move into the Phase 2 segment of our 2/3 trial on the pathway to establish our DNA technology as an integral component of the pandemic response given its potential for an outstanding safety profile and its demonstrable thermostability.
“I am particularly grateful for the confidence instilled in us by the U.S. Department of Defense, a partnership to ensure that healthcare workers, frontline responders, our elderly as well as our military servicemembers are protected from Covid-19.”
The Phase 2 part of the INNOVATE trial is planned to enrol around 400 participants, aged 18 years or older, at up to 17 sites in the US.
The study will evaluate safety and immunogenicity of INO-4800 in a 2-dose regimen, including 1.0mg and 2.0mg, to determine the appropriate dosing for people at high risk of SARS-CoV-2 exposure, to be studied in the Phase 3 part of the trial.
The Phase 3 part of the INNOVATE trial will be kept partially hold until the company resolves the US regulator’s remaining queries related to the CELLECTRA 2000 device, which will be used for delivery of INO-4800 into the skin cells.
Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the US Department of Defence have offered funding support to advance the manufacturing of INO-4800.
Also, the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and Laval University, have supported the company as R&D collaborators.