CatalYm to Present Positive New Phase 2a Follow-up Data on GDF-15 Neutralizing Antibody Visugromab in Advanced NSCLC, Urothelial, and Hepatocellular Cancer at the 2024 ASCO Annual Meeting

MUNICH--(BUSINESS WIRE)-- CatalYm today announced that positive new follow-up results from its ongoing “GDFATHER” Phase 1/2a trial (GDF-15 Antibody-mediaTed Human Effector Cell Relocation Phase 1/2a) will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 in Chicago.

The trial is evaluating CatalYm’s lead GDF-15 neutralizing antibody, visugromab, in combination with immune checkpoint inhibitor nivolumab in late- to last-line, anti-PD-1/PD-L1 relapsed/refractory patients. Visugromab is designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15), a central mediator of immune resistance to cancer therapies. Early interim data of the study, which were previously presented at the ESMO Immuno-Oncology Congress 2023, demonstrated signs for potent and durable anti-tumor efficacy as well as an excellent tolerability and safety profile for visugromab in combination with nivolumab in advanced-stage/last-line non-small cell lung cancer (NSCLC) and urothelial cancer patients (UC). Now matured data for NSCLC, UC and novel data for hepatocellular cancer (HCC) will be presented.

The ASCO Annual Meeting will be held in Chicago, Illinois, from May 31 to June 4, 2024.

Oral Presentation Details:

Presentation Title: Effects of neutralization of tumor-derived immunosuppressant GDF-15 on anti-PD-1 activity in anti-PD-(L)1 relapsed/refractory non-squamous NSCLC, urothelial, and hepatocellular cancer
Presenter: Dr. Ignacio Melero Bermejo, MD | Clinica Universidad de Navarra
Session: Developmental Therapeutics-Immunotherapy
Session Date and Time: Sunday, June 2, 2024, from 11:30 AM – 1:00 PM CDT
Location: S406 | On Demand | McCormick Place
Abstract Number: 2513

The full abstract details can be accessed via https://meetings.asco.org/abstracts-presentations/234019. The company will provide further information and a summary of the data following the oral presentation at ASCO.

About the GDFATHER-2 Trials

The GDFATHER-2 trial (GDF-15 Antibody-mediaTed Human Effector cell Relocation Phase 2) (NCT04725474) is the Phase 2a part of the ongoing Phase 1/2a trial with several cohorts investigating the effect of visugromab (CTL-002) in combination with a PD-1 checkpoint inhibitor in patients in various advanced-stage/last-line and by strict criteria anti-PD1/PD-L1 relapsed/refractory solid tumor types. The study can enroll up to 200 patients and has extensive biomarker-evaluations integrated to assess for potential responder patient population identification or similar.

About Visugromab (CTL-002)

Visugromab is a monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by reenabling immune cell activation and tumor infiltration. Visugromab has demonstrated already in Phase 1 a good safety profile and potent and durable anti-tumor efficacy in combination with anti-PD-1 treatment in advanced cancer patients The antibody is currently being investigated in ongoing Phase 2 studies in multiple solid tumor indications.

About CatalYm

CatalYm has identified GDF-15 as a key cancer therapy resistance mechanism and is developing it as safe and efficacious immune therapy for solid tumors. GDF-15, an immunosuppressant important for feto-maternal tolerance, is hijacked by cancer cells to evade immune system attack. Visugromab, CatalYm’s lead antibody, has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. CatalYm is now advancing to Phase 2b studies to confirm visugromab as a new class of cancer immunotherapy in a broad range of anti-cancer regimens.

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