INOVIO: Positive Data from Phase 2 Trial Evaluating 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 segment of the trial
Data published as a preprint in MedRxiv

PLYMOUTH 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.

Findings from the Phase 2 Clinical Trial:

• 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 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: NCT04642638

INOVIO plans to file preliminary Phase 2 results and device data with the U.S. Food and Drug Administration (FDA). Following the submission and FDA concurrence to proceed, the company plans to conduct a global Phase 3 clinical trial for INO-4800. The company recognizes the growing and unmet global demand for both initial as well as boosting doses of COVID-19 vaccines and looks forward to supporting the rollout of much needed additional vaccines to prevent the spread of COVID-19 – including both current and future variants – around the world.

https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Announces-Positive-Data-from-Phase-2-Segment-of-Clinical-Trial-Evaluating-INO-4800-its-COVID-19-DNA-Vaccine/default.aspx