On September 30, 2021 CatalYm reported that a data update from their ongoing first-in-human trial "GDFather" (GDF-15 Antibody-mediated Effector cell Relocation) has been accepted for oral presentation at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Catalym, SEP 30, 2021, View Source [SID1234590594]). The conference will be held virtually from October 7 -10, 2021.
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"GDF-15 is frequently overexpressed in various tumor types and appears to play a central role in suppressing several key mechanisms by which the immune system recognizes and eliminates tumors, making it an exciting target in immuno-oncology drug development. We look forward to presenting an update from this trial to the scientific community in an oral plenary session," said Eugen Leo, MD, PhD, MBA, Chief Medical Officer at CatalYm.
Details of the oral presentation:
Presentation title: A phase I, first-in-human clinical trial of the GDF-15 neutralizing antibody CTL-002 in subjects with advanced stage solid tumors
Session title: New Drugs on the Horizon II
Speaker: Eugen Leo, MD, PhD, MBA, Chief Medical Officer of CatalYm
Date/time: October 9, 2021, at 4.05 pm ET/22.05 pm CEST
About the GDFather Trial
The ongoing first-in-human GDFather trial (GDF-15 Antibody-mediaTed Effector cell Relocation) is a two-part, open-label study to evaluate GDF-15 inhibitor CTL002 in advanced, checkpoint inhibitor refractory or relapsed solid tumor patients. In the dose escalation phase (Part A), up to 24 patients will receive escalating doses of CTL-002 in a "3+3" manner with the lead candidate given as a monotherapy and followed by combination with an anti-PD-1 checkpoint inhibitor. In the second dose expansion phase (Part B, phase 2a), several cohorts with tumors identified to be GDF-15-dependent will be treated to further evaluate safety and preliminary efficacy of CTL-002 treatment.
About CTL-002
CTL-002 is a humanized, monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15). GDF-15 secretion by the tumor has been shown to prevent T cell migration into the tumor and suppresses T cell function and the adaptive immune response in the tumor microenvironment. All these mechanisms help the tumor evade the immune system and become resistant to standard of care and current immunotherapy approaches such as checkpoint inhibitors. CTL-002 counteracts these immuno-suppressive mechanisms by neutralizing GDF-15, enhancing the infiltration of immune cells into the tumor, improving both priming of T cells by dendritic cells and tumor killing by T cells and NK cells.