FDA Lifts Partial Clinical Hold on INNOVATE Phase 3 Segment
PLYMOUTH MEETING, Pa., Nov. 9, 2021 — INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases and treat cancer and HPV-associated diseases, today announced that the U.S. Food and Drug Administration (FDA) provided authorization to proceed for INOVIO’s INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S. The FDA has lifted the partial clinical hold following the FDA’s review of additional non-clinical, clinical, and device information provided by INOVIO.
Dr. J. Joseph Kim, INOVIO’s President and CEO, said, “I want to recognize and express my appreciation to my INOVIO colleagues for their hard work throughout this process. We are pleased to have the opportunity for U.S. clinical trial participants to potentially contribute to the enrollment in our INNOVATE Phase 3 segment. Today’s U.S. announcement builds on our intensive global efforts in India, Brazil, Philippines, Mexico, Colombia, and Thailand where we have received authorizations to date.”
INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to conduct the INNOVATE Phase 3 segment in multiple countries in the Americas, Asia, and Africa. The global Phase 3 segment of INNOVATE will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart, in a 2-to-1 randomization in men and non-pregnant women 18 years of age and older. The primary endpoint of this case-driven Phase 3 trial is virologically confirmed symptomatic COVID-19.
