MUNICH–(BUSINESS WIRE)–CatalYm today announced that the mature results from its Phase 1, first-in-human trial “GDFATHER-1” (GDF-15 antibody-mediated human effector cell relocation) will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022. The trial evaluated CatalYm’s lead GDF-15 neutralizing antibody visugromab (previously known as CTL-002), in combination with immune checkpoint inhibitor nivolumab in last-line, anti-PD-1/PD-L1 relapsed/refractory patients. Growth and differentiation factor 15 (GDF-15) is recognized as a negative regulator of antitumoral T cell activity preventing T cell recruitment to the tumor microenvironment as well as potently suppressing an adaptive immune response by additional mechanisms recently identified. The ESMO congress will be held in Paris, France, from September 9 to 13, 2022.
Oral presentation details:
Presentation Title: Final results of the first-in-human clinical trial of the GDF-15 neutralizing antibody CTL-002 in combination with nivolumab in subjects with solid tumors relapsed/refractory to prior anti-PD-1/PD-L1 treatment.
Presenter: Dr. Ignacio Melero Bermejo, MD | Universidad de Navarra
Session: Investigational immunotherapy
Session Date and Time: Saturday September 10, 2022, from 2:45 PM – 4:15 PM CEST
Location: In-Person & Live Stream | Paris Expo Porte de Versailles, 7.3.O – Orléans Auditorium
Presentation Number: 729MO
About the GDFATHER-1 Trial
The GDFATHER-1 trial (GDF-15 antibody-mediated human effector cell relocation) is the first-in-human study of visugromab (CTL-002). This dose escalation study recruited 25 patients that received escalating doses of visugromab (CTL-002) in a “3+3” manner with the lead candidate given as a monotherapy for two weeks, then followed by combination with an anti-PD-1 checkpoint inhibitor.
About Visugromab (CTL-002)
Visugromab, formerly known as 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. This enables the tumor to evade the immune system and become resistant to standard of care and current immunotherapy approaches such as checkpoint inhibitors. Visugromab 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.
CatalYm has identified GDF-15 as a central regulator of the immune system in the tumor microenvironment. We are pioneering the reversal of GDF-15-mediated immunosuppression to induce a potent antitumoral immune reaction in non-responsive tumors. CatalYm’s lead program CTL-002 is poised to demonstrate clinical proof-of-concept in multiple solid tumor indications which will expand the treatment horizon for current and future immunotherapies.