26 July 2024 | Friday | News
Picture Courtesy | Public Domain
NOVIO a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, announced that the European Medicines Agency's Committee for Advanced Therapies (CAT) has certified the quality and non-clinical data for INO-3107, INOVIO's lead candidate for the treatment of Recurrent Respiratory Papillomatosis (RRP).
The certification confirms that INOVIO's chemistry, manufacturing and controls (CMC) 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.
"This latest regulatory achievement further validates our efforts to bring INO-3107 to RRP patients around the world and shows that our cross functional development team is meeting the highest of standards in pursuit of that goal," said Cheryl Elder, INOVIO's Senior Vice President of Regulatory Affairs. "We're pleased to receive confirmation that our development efforts in Europe continue to make progress."
The CAT provides assessment and certification of advanced therapy medicinal products (ATMPs) under development by micro-, small- and medium-sized enterprises (SMEs), providing an important opportunity to identify any potential development issues prior to the submission of a Marketing Authorization Application.
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