Inovio’s INO-3107 granted Advanced Therapy Medicinal Product Certificate by EMA

Innovio announced that the European Medicines Agency’s Committee for Advanced Therapies has certified the quality and non-clinical data for INO-3107, INOVIO’s lead candidate for the treatment of Recurrent Respiratory Papillomatosis. The certification confirms that INOVIO’s chemistry, manufacturing and controls data and nonclinical results available to date comply with the scientific and technical standards that would be used for evaluating a European Marketing Authorization Application. The CAT provides assessment and certification of advanced therapy medicinal products under development by micro-, small- and medium-sized enterprises, providing an important opportunity to identify any potential development issues prior to the submission of a Marketing Authorization Application.