The US Food and Drug Administration (FDA) has placed partial clinical hold on Inovio Pharmaceuticals‘ planned Phase II/III clinical trial of its potential Covid-19 vaccine, INO-4800.
The regulator asked the company to provide more information on the trial, including details about the use of CELLECTRA 2000 delivery device.
Inovio would respond to FDA’s queries in October, after which the agency will have up to 30 days to decide whether the trial may proceed.
The company noted that the partial clinical hold was not due to any adverse events in the expanded Phase I study of the vaccine candidate, which is ongoing and will continue.
Phase I interim analysis showed that the product was generally safe and well-tolerated.
Inovio further said: “In addition, this partial clinical hold does not impact the advancement of Inovio’s other product candidates in development.
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“Inovio and its partners are continuing to prepare for a planned Phase II/III 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.”
The company has formed alliances with a global coalition of collaborators, partners and funders to rapidly develop INO-4800 against Covid-19.
So far, its R&D collaborators include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and Laval University.
The company has partnered with Advaccine and the International Vaccine Institute for trials of the vaccine candidate in China and South Korea, respectively.
Furthermore, the company is working with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia to test INO-4800’s non-clinical efficacy.
A team of contract manufacturers, including Thermo Fisher Scientific, Richter-Helm BioLogics and Ology Bioservices, are working to commercially produce the product.
Following funding from the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation and the US Department of Defense, the company is seeking additional finance to support the INO-4800 project.