CatalYm's Phase 2a trial for Visugromab in late-stage NSCLC and bladder cancer shows promising results at 2023 ESMO Immuno-Oncology Meeting

CatalYm has made an announcement regarding the progression of their Phase 2a study with the release of advancing results from the GDFATHER-2 trial, which is currently in progress. The trial, whose full title stands for GDF-15 Antibody-mediaTed Human Effector Cell Relocation Phase 2, had key findings shared during a spoken presentation that took place at the 2023 ESMO Immuno-Oncology Congress hosted in Geneva, Switzerland.

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Research indicates that the pairing of CatalYm's primary investigative drug visugromab with nivolumab presents robust anti-cancer effects in individuals diagnosed with non-small cell lung cancer (NSCLC) and urothelial cancer that have previously shown resistance to treatments targeting PD-1/PD-L1. This therapeutic combination also maintains a favorable safety and tolerability profile. Visugromab is an engineered monoclonal antibody targeting Growth Differentiation Factor-15 (GDF-15), which plays a pivotal role in immunological evasion mechanisms in cancer treatment.

During his speech, Prof. Ignacio Melero, MD, PhD, Co-Director of Immunology and Immunotherapy at Universidad de Navarra in Pamplona, Spain, expanded upon the breadth of visugromab's clinical data. Prof. Melero showcased the potential advantages of inhibiting GDF-15 for patients with metastatic neoplasms.

Prof. Eugen Leo, CatalYm's Chief Medical Officer, asserts that the observed effectiveness and the sustained response especially stand out for advanced and last-line NSCLC and urothelial carcinoma cases that did not respond to prior anti-PD-1/PD-L1 strategies and are undergoing immune-oncology combination therapy. 

He notes that the prolonged response—which is still ongoing in 6 out of 8 patients—underscores the potential of this regimen to re-establish enduring immune-mediated control of the tumor in patients with advanced cancer types who have exhausted other conventional treatment options and have become resistant to earlier anti-PD-1/PD-L1 therapies based on stringent criteria. Prof. Leo further noted the significance of these durable responses.

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According to the data provided by the Synapse Database, As of December 13, 2023, there are 19 investigational drugs for the GDF15 target, including 22 indications, 20 R&D institutions involved, with related clinical trials reaching 20, and as many as 2862 patents.

Visugromab is a monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15. 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.