Plymouth Meeting-based INOVIO has announced that the U.S. Food and Drug Administration 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 U.S. Food and Drug Administration questions have been satisfactorily addressed, INOVIO’s Investigational New Drug Application for the Phase 2/3 trial is on partial clinical hold. The company stated in a press release that it is actively working to address the administration’s questions and plans to respond in October, after which the administration will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed.
From the press release:
This 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.
According to Business Insider, INOVIO’s stock lost 39% of its value when the news was released.