Inovio Pharma (INO) Planning for ex-US Global Phase 3 Trial for INO-4800, DHA to Discontinue Funding for Phase 3 Segment of INNOVATE Trial

(Updated - April 23, 2021 8:11 AM EDT)

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 that it is planning for a predominantly ex-U.S. Phase 3 trial for its COVID-19 vaccine candidate, INO-4800. Given the increasing availability of vaccines authorized for emergency use, the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA), will discontinue funding for the Phase 3 segment of the INNOVATE trial, while continuing to fund the completion of the ongoing Phase 2 segment. In correspondence, JPEO informed INOVIO: "The decision results from the changing environment of COVID-19 with the rapid deployment of vaccines. This decision is not a reflection of the awardee or product, rather a fast-moving environment associated with the former Operation Warp Speed on decisions related to future products."

This decision does not impact other work that INOVIO does with the US government and is neither a result of the partial clinical hold nor a reflection of the data generated to date for INO-4800 vaccine. With existing global collaborators such as INOVIO's China partner, Advaccine, and the International Vaccine Institute (IVI,) the company is planning for a predominantly ex-US global Phase 3 trial based on upcoming evaluation of Phase 2 safety and immunogenicity data. INOVIO continues to evaluate its pan-COVID variant vaccine, INO-4802, to protect against current and future variants of concern, as well as assessing boosting capabilities for INO-4800. INOVIO remains well-positioned to support both pandemic and endemic vaccine needs with INO-4800 and INO-4802. INOVIO and its partners and collaborators look forward to being part of the global solution to prevent the spread of COVID-19 – including both current and future variants.

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