INOVIO, a biotechnology company focused on precisely designed DNA medicines, achieved positive safety, tolerability and immunogenicity data from its placebo-controlled and blinded Phase 2 segment of its Phase 2/3 clinical trial 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 2 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. Each dose was administered by intradermal injection followed by electroporation using INOVIO’s CELLECTRA®, its proprietary smart device.
 
Vaccine administration was generally safe and well-tolerated. The majority of adverse events 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.
 
INOVIO plans to file preliminary Phase 2 results and device data with the U.S. FDA and plans to conduct a global Phase 3 clinical trial for INO-4800.