PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) has announced a significant milestone for its lead candidate, INO-3107, aimed at treating Recurrent Respiratory Papillomatosis (RRP). The European Medicines Agency’s Committee for Advanced Therapies (CAT) has certified the quality and non-clinical data for the treatment, a crucial step toward regulatory approval.
The certification affirms that INOVIO’s chemistry, manufacturing, and controls (CMC) data, along with non-clinical results, meet the scientific and technical standards required for a European Marketing Authorization Application. This achievement highlights the company’s commitment to maintaining high standards in its development efforts.
“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 plays a crucial role in evaluating advanced therapy medicinal products (ATMPs) developed by small and medium-sized enterprises (SMEs). Its certification process helps identify potential development issues early, providing a valuable opportunity for companies like INOVIO to address them before submitting a Marketing Authorization Application.
This certification marks a significant step forward for INOVIO, signaling progress in its mission to bring innovative treatments to patients suffering from RRP. The company continues to focus on meeting stringent regulatory standards as it advances its development pipeline in the global market.
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