CatalYm begins clinical development of CTL-002 to treat certain oncology patientsJanuary 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). 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 company said.
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.
CatalYm’s trial is approved by regulators in Spain, Switzerland and Germany and may enroll up to 149 patients into part A and B combined.
Prof. Dr. Eugen Leo, Chief Medical Officer of CatalYm, said that the research has shown GDF-15 to be a malicious, tumor-produced factor that blocks immune effector cells from entering the tumor, thus interfering with immune cell activation and the killing of tumor cells. He said that blocking GDF-15 with CTL-002 should make modern immunotherapies more effective and potentially provide a major leap forward for the group of GDF-15-mediated checkpoint-inhibitor relapsed/refractory patients.
“Moreover, we are delighted that regulators appreciated our efficient and tailored trial design that includes the immediate combination of CTL-002 with a checkpoint inhibitor allowing participating patients access to a promising, attractive antibody combination therapy from the very start of this clinical trial,” he said.
Dr. Manfred Rüdiger, CEO of CatalYm, said: “We are proud of having achieved this important milestone, during this challenging time, that has involved great contributions from our team and our advisors. We look forward to delivering potentially better treatment options for patients failing on current checkpoint blocker treatment regimes.”