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."
With the business potentially at an important milestone, we thought we'd take a closer look at Inovio Pharmaceuticals...
Inovio Pharmaceuticals (NASDAQ: INO) was among the first to start clinical trials on a coronavirus vaccine candidate. The U.S. Food and Drug Administration (FDA) last fall placed one of Inovio's vaccine trials on a partial clinical hold, and the program fell behind. Now, Inovio's candidate is in phase 2.