IDM Pharma has received a special protocol assessment (SPA) from the FDA for the planned Phase II/III clinical trial of Bexidem for the treatment of superficial bladder cancer.
Bexidem is composed of monocyte-derived activated killer (MAK) cells. IDM produces MAK cells from the patient's own white blood cells by activating these cells ex vivo to allow them to recognize and destroy tumor cells. MAK cell products are designed to be reinjected into the patient to act locally and kill cancer cells. Bexidem is in development as an adjuvant treatment after transurethral resection, TUR, in patients who have failed a treatment of superficial bladder cancer with BCG, a vaccine that was developed for the treatment of tuberculosis. Following recovery from surgery, Bexidem is delivered directly into the patient's bladder.