Biotechnology firm Inovio has dosed the first participant in a Phase II segment of its Phase II / III INovio INO-4800 Vaccine Trial for Efficacy (INNOVATE) trial analysing its Covid-19 vaccine candidate, INO-4800.
INO-4800 is a prophylactic DNA vaccine candidate that is stable at room temperature for over a year and requires no freezing during transport or storage.
The randomised, blinded, placebo-controlled INNOVATE trial analysing safety and efficacy of INO-4800 is taking place in the US.
The US Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) are funding the INNOVATE trial, along with the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) and the Defense Health Agency (DHA).
The Phase II part will enrol approximately 400 adults at up to 17 sites in the US to analyse safety and immunogenicity to ascertain the dose(s) for the subsequent efficacy analysis as part of the Phase III segment.
Researchers will evaluate a two-dose regimen, 1mg or 2mg, of INO-4800 throughout the trial.
Participants randomised in a three-to-one ratio will receive either INO-4800 or placebo to confirm the more appropriate dosing level(s) for each of three age groups, 18-50, 51-64 and 65 years and above, at increased risk of SARS-CoV-2 exposure for the Phase III efficacy analysis.
Inovio intends to complete enrolment in the Phase II segment of the trial by the end of the month.
Inovio president and CEO Dr Joseph Kim said: “We’re pleased to move into the Phase II segment of our II / III 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.”
The DoD will provide funding for both segments of INNOVATE trial.
In June, DoD agreed to give funds worth $71m for the large-scale manufacture of Inovio’s smart device CELLECTRA 3PSP and procurement of CELLECTRA 2000 devices.
Last week, Inovio entered an agreement with Kaneka Eurogentec to manufacture INO-4800 at the latter’s leading GMP plasmid production scales.