Immunicum has treated the first patient in the Phase Ib/II clinical trial of its lead product in development, ilixadencel (ILIAD), in combination with checkpoint inhibitors (CPIs) in three cancer indications: head and neck cancer, non-small cell lung cancer and gastric cancer.
Peter Suenaert, Chief Medical Officer at Immunicum, sees this study as a test of potential of Iliad as a backbone component in combination therapies to treat solid tumors. He says the company will continue exploring the synergistic effects of the immune activity of ilixadencel together with CPIs.
The ILIAD trial is an open-label multicenter study fully sponsored by Immunicum. The Principal and Coordinating Investigator for the study is Dr. J. Weiss, Associate Professor of Medicine at the School of Medicine at University of North Carolina-Chapel Hill.
“With the first patient starting treatment, we have achieved another key milestone for Immunicum,” said Carlos de Sousa, CEO of Immunicum.
De Sousa saisd Immunicium will report after each dosing group is completed, expecting to have the first announcement related to the trial in the second half of 2019.
The Phase II part, which will include up to 150 patients, will consist of three randomized, controlled studies in these indications conducted at centers in the United States and across Europe. These studies will further determine the safety and efficacy of ilixadencel when administered together with CPI therapy. Specifically, in NSCLC ilixadencel will be combined with pembrolizumab (Keytruda®) and in HNSCC and GA/GEJ it will be combined with avelumab (Bavencio®), which will be supplied by Merck KGaA, Darmstadt, Germany, and Pfizer under a collaboration agreement.
by Dino Mustafić