INOVIO Reports FDA Partial Clinical Hold for Planned Phase 2 / 3 Trial of COVID-19 Vaccine Candidate INO-4800

INOVIO | September 28, 2020

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. 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.

Spotlight

The discovery of both CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and associated proteins, the Cas nucleases, has revolutionized the field of gene-editing. 

Spotlight

The discovery of both CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and associated proteins, the Cas nucleases, has revolutionized the field of gene-editing. 

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