CATALYM STARTS FIRST-IN-HUMAN PHASE I CLINICAL TRIAL WITH GDF-15 NEUTRALIZING ANTIBODY CTL-002 TO TREAT PATIENTS WITH CHECKPOINT- INHIBITOR REFRACTORY CANCER
Munich, Germany, January 28, 2021—CatalYm GmbH, a biopharmaceutical company developing novel cancer immunotherapies, announced today the start of clinical development of CTL-002, its proprietary GDF-15 neutralizing antibody designed to enhance effector T cell entry into the tumor microenvironment. The first patient was enrolled and treated safely in December 2020 in this first clinical trial with CTL-002, acronymed GDFATHER (GDF-15 Antibody-mediaTed Effector cell Relocation, NCT04725474).
GDFATHER is an open-label, multicenter, Phase I clinical trial evaluating intravenous (IV) administration of CTL-002 as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor. The trial is recruiting patients with advanced-stage, solid tumors, who have relapsed or are refractory to previous anti-PD-1/PD-L1 treatments. The trial is designed with two stages: Part A being a dose escalation study to MTD of CTL-002 in combination with a checkpoint inhibitor and part B expansion cohorts of dedicated GDF-15-dependent tumor indications that are checkpoint inhibitor relapsed/refractory. The trial is approved by regulators in Spain, Switzerland and Germany and may enroll up to 149 patients into part A and B combined.