CatalYm to Present New Positive Phase 2a Data on Visugromab in Advanced Cancers at 2024 ASCO Meeting

CatalYm has announced promising follow-up results from its ongoing “GDFATHER” Phase 1/2a trial, which will be highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 in Chicago. The trial explores the efficacy of CatalYm’s lead GDF-15 neutralizing antibody, visugromab, in combination with the immune checkpoint inhibitor nivolumab for patients who have relapsed or are refractory to anti-PD-1/PD-L1 treatments.

Visugromab aims to neutralize Growth Differentiation Factor-15 (GDF-15), a tumor-produced protein that plays a key role in immune resistance against cancer therapies. Previously, early interim data presented at the ESMO Immuno-Oncology Congress 2023 indicated that visugromab, in combination with nivolumab, showed robust and lasting anti-tumor effects along with excellent safety and tolerability in patients with advanced non-small cell lung cancer (NSCLC) and urothelial cancer (UC). The upcoming ASCO presentation will reveal matured data for NSCLC, UC, and new findings for hepatocellular cancer (HCC).

The ASCO Annual Meeting will take place in Chicago, Illinois, from May 31 to June 4, 2024. The oral presentation, titled "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," will be delivered by Dr. Ignacio Melero Bermejo from Clinica Universidad de Navarra. The session, "Developmental Therapeutics-Immunotherapy," is scheduled for Sunday, June 2, 2024, from 11:30 AM to 1:00 PM CDT at McCormick Place in room S406.

The GDFATHER-2 trial, which is part of the ongoing Phase 1/2a trial, is investigating visugromab in combination with a PD-1 checkpoint inhibitor in various advanced-stage and last-line solid tumors that are resistant or have relapsed after anti-PD-1/PD-L1 treatments. The study aims to enroll up to 200 patients and includes extensive biomarker evaluations to identify potential responder populations.

Visugromab (CTL-002) is a monoclonal antibody designed to neutralize GDF-15, an immunosuppressant produced by tumors to resist immunotherapy. By neutralizing GDF-15, visugromab helps to restore an effective anti-tumor immune response by reactivating immune cells and facilitating tumor infiltration. In Phase 1 trials, visugromab has shown excellent safety and durable anti-tumor efficacy when combined with anti-PD-1 treatments in advanced cancer patients. Current Phase 2 studies are examining its effectiveness in multiple solid tumor types.

CatalYm has identified GDF-15 as a significant factor in cancer therapy resistance and is developing visugromab as a safe and effective immunotherapy for solid tumors. GDF-15, which is crucial for feto-maternal tolerance, is exploited by cancer cells to evade immune attacks. Visugromab has demonstrated long-lasting anti-tumor responses in relapsed and refractory metastatic solid tumor patients when used with anti-PD-1 treatments. CatalYm is advancing to Phase 2b studies to validate visugromab as a new class of cancer immunotherapy for a broad range of anti-cancer regimens. 

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