Policy & Regulation
INOVIO announces FDA partial clinical hold for proposed Phase 2 / 3 trial of COVID-19 vaccine candidate INO-4800
29 September 2020 -

Biotechnology company INOVIO Pharmaceuticals Inc (NASDAQ:INO) said on Monday that the US Food and Drug Administration (FDA) has responded with additional queries about its planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA 2000 delivery device.

Until the FDA questions have been addressed, the company said its Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold, which is is not due to the occurrence of any adverse events related to the ongoing expanded Phase 1 study of INO-4800.

In conjunction with the US FDA's partial clinical hold, the company is actively working to address the agency's questions and plans to respond in October, upon which, the FDA will have up to 30 days to notify of its decision as to whether the trial may proceed.

The company has formed a global coalition of collaborators, partners and funders with the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and Laval University to rapidly advance the development of INO-4800. It has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively.

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