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INOVIO Reports FDA Partial Clinical Hold for Planned Phase 2 / 3 Trial of COVID-19 Vaccine Candidate INO-4800
PLYMOUTH MEETING, Pa., Sept. 28, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":" PLYMOUTH MEETING, Pa., Sept. 28, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the trial. Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold. The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed. \nThis partial clinical hold is not due to the occurrence of any adverse events related to INOVIO's ongoing expanded Phase 1 study of INO-4800, the conduct of which may continue and is not impacted by the FDA's notification. In addition, this partial clinical hold does not impact the advancement of INOVIO's other product candidates in development. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding to conduct the trial.\nAbout INOVIO's Global Coalition Advancing INO-4800\nINOVIO has assembled a global coalition of collaborators, partners, and funders to rapidly advance the development of INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and Laval University. INOVIO has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing nonclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia. INOVIO is working with a team of contract manufacturers including Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Bioservices to manufacture INO-4800 on a commercial scale and is seeking additional external fundin...