Immunicum announces that the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France has approved the company’s Clinical Trial Application (CTA) for INTUVAX.
The CTA approval enables Immunicum to include patients in France in its ongoing Phase II study – MERECA (MEtastatic REnal Cell CArcinoma) – for the treatment of metastatic renal cell cancer.
“This approval from the ANSM allows us to move forward with recruitment of patients in France, a large and important location for the MERECA trial,” said Dr. Carlos de Sousa, CEO of Immunicum. “It also represents the last outstanding EU country for which we were awaiting CTA approval.”
INTUVAX is a cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated white blood cells, so called dendritic cells, derived from healthy blood donors. Intratumoral injection of these cells is expected to lead to an inflammatory response which in turn leads to tumor-specific activation of the patient’s cytotoxic T-lymphocytes.