Inovio has secured approval from the US Food & Drug Administration (FDA) to begin phase 2 segment of its planned phase 2/3 clinical trial for its Covid-19 DNA vaccine candidate.
The phase 2 segment will evaluate the efficacy of Covid-19 DNA vaccine candidate called INO-4800 in adults in the US.
Inovio’s study will be financed by the US Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in correlation with the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) and the Defense Health Agency (DHA).
Inovio INO-4800 vaccine trial for efficacy (INNOVATE) is a randomised, blinded and placebo-controlled safety and efficacy study designed to assess the safety, tolerability and immunogenicity of INO-4800 in a two-dose regimen (1.0mg or 2.0mg) in a three-to-one randomisation.
The age groups, including 18-50 years, 51-64 years and 65 years and older, will secure either INO-4800 or placebo for each dose to confirm the more appropriate dose(s) for the subsequent phase 3 efficacy assessment.
The phase 3 segment of the INNOVATE trial will be on partial clinical hold until the company satisfactorily resolves the FDA’s remaining questions associated to the CELLECTRA 2000 device, which will be used to offer INO-4800 directly into the skin.
Inovio intends to address the remaining device questions during the conduct of Phase 2 segment and before starting the phase 3 segment of the trial.
The regulator’s authorisation is based on its assessment of INOVIO’s non-clinical data, device information and interim phase 1 safety and immunogenicity data, in addition to the designing and planning of phase 2 and phase 3 segments of the planned study. Inovio is planning to recruit around 400 participants at up to 17 US sites.
Inovio president and CEO Dr Joseph Kim said: “We are especially pleased to continue our partnership with the DoD to advance the development of INO-4800 for active duty service members and civilian personnel and are grateful for the Department’s continued confidence in our technology to combat Covid-19.”