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INOVIO Announces Positive Data from Phase 2 Segment of Clinical Trial Evaluating INO-4800, its COVID-19 DNA Vaccine
INO-4800 was shown to be safe, well-tolerated and immunogenic in all age groups Phase 2 results informed INOVIO's selection of 2.0 mg dose for the Phase 3
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"INO-4800 was shown to be safe, well-tolerated and immunogenic in all age groups\n Phase 2 results informed INOVIO's selection of 2.0 mg dose for the Phase 3 segment of the trial\n Data published as a preprint in MedRxiv\n\n\nPLYMOUTH MEETING, Pa., May 10, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced positive safety, tolerability and immunogenicity data from its placebo-controlled and blinded Phase 2 segment of its Phase 2/3 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.\nFindings from the Phase 2 Clinical Trial:\nThe 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 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-γ) 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. ClinicalTrials.gov identifier: NCT04642638The Phase 2 segment of INNOVATE was designed to ev...