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Inovio's COVID-19 DNA Vaccine Candidate Safe And Well-tolerated In Phase 2 Trial

Inovio Pharmaceuticals Inc.'s (INO) DNA vaccine candidate for COVID-19, INO-4800, was generally safe, well-tolerated and immunogenic in all studied age groups, as per a phase 2 segment of its phase 2/3 clinical trial.

In Monday pre-market trade, INO was trading at $7.07, up $0.22 or 3.21 percent.

The phase 2 segment of its phase 2/3 clinical trial in the U.S., called INNOVATE, was designed to evaluate the safety, tolerability and immunogenicity of INO-4800 in a two-dose regimen (1.0 mg or 2.0 mg) in a three-to-one-randomization to receive either INO-4800 or placebo for each dose to identify optimal dose(s) for two age groups (18-50 years and 51 years and older) for the subsequent Phase 3 efficacy evaluation.

The Phase 2 segment of the trial enrolled about 400 participants, 18 years of age or older, at 16 U.S. sites.

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.

According to the preliminary results, 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. Food and Drug Administration. The company plans to conduct a global Phase 3 clinical trial for INO-4800. The company has selected 2.0 mg dose for the phase 3 segment of the trial.

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