The company’s investigational new drug application (IND) for the clinical trial will be on partial clinical hold until the regulator receives satisfying answers for the questions.
The partial clinical hold is also imposed on the CELLECTRA 2000 delivery device, which will be used in the trial.
Inovio stated that it is focusing more on addressing the FDA’s questions and intends to reply in October.
The firm also noted that the partial clinical hold is not due to the occurrence of any adverse events associated with its ongoing expanded phase 1 study of INO-4800.
Following the resolution of the FDA’s partial clinical hold, Inovio and its partners continue to prepare for a planned phase 2/3 trial of INO-4800. The trial is also subject to the receipt of external funding.
Inovia has gathered a global coalition of collaborators, partners, and funders to expedite the development of INO-4800.
The current research and development (R&D) collaborators include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and Laval University.
Inovio has collaborated with Advaccine and the International Vaccine Institute to carry out clinical trials of INO-4800 in China and South Korea.
The firm is also evaluating nonclinical efficacy of INO-4800 in various animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia.
The company has collaborated with contract manufacturers such as Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Bioservices for the commercial production of INO-4800.
In addition, the company is focusing on securing additional external funding and establishing partnerships to advance manufacturing capacities to meet the demand for safe and effective vaccines.
The Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the US Department of Defense provided majority funds for the advancement and manufacturing of INO-4800, said Inovio.