INOVIO announces positive data from phase II segment of clinical trial evaluating INO-4800, its COVID-19 DNA Vaccine.

INOVIO announced positive safety, tolerability and immunogenicity data from its placebo-controlled and blinded Phase II segment of its Phase II/III clinical trial in the U.S., called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), evaluating INO 4800, its DNA vaccine candidate for COVID-19. Preliminary results show in a larger population that INO 4800 was generally safe, well-tolerated and immunogenic in all studied age groups. The Phase II segment of the trial enrolled approximately 400 participants, 18 years of age or older, at 16 U.S. sites. Participants received either INO-4800 (1.0 mg or 2.0 mg dose) or placebo at 0 and 4 weeks (randomized 3:3:1:1). Each dose was administered by intradermal injection followed by electroporation using INOVIO's CELLECTRA, its proprietary smart device. Safety endpoints included systemic and local administration site reactions through 8 weeks post-dose one (or 4 weeks post-dose 2). Immunology endpoints included antigen-specific binding antibody titers, neutralization titers, and antigen-specific interferon-gamma (IFN-?) cellular immune responses after two doses of the vaccine. Vaccine administration was generally safe and well-tolerated. The majority of adverse events (AEs) were Grade 1 and Grade 2 in severity and did not appear to increase in frequency with the second dose. The number of participants experiencing each of the most common AEs did not differ between the two dosing groups. The geometric mean fold rise (GMFR) of binding and neutralizing antibody levels were statistically significantly greater in the 2.0 mg dose group versus the 1.0 mg dose group. The T cell immune responses measured by the ELISpot assay were also higher in the 2.0 mg dose group compared to the 1.0 mg dose group.