Biotech company CatalYm from Planegg near Munich published data of the first-inhuman Phase 1/2a study of its lead drug candidate visugromab Nature. The paper titled “Neutralizing GDF-15 can overcome anti-PD-(L)1 resistance in solid tumors” emphasizes the significant potential of visugromab to induce unprecedented cancer remission depth and durability across multiple solid tumor indications as well as in combination with nivolumab in late- to last-line solid tumors.
Visugromab is a humanized, monoclonal antibody that counteracts GDF-15, a critical immunosuppressant used by tumor cells to survive. The clinical data confirmed that inhibiting GDF-15 promotes T-cell infiltration into the tumor microenvironment. This presents an approach to overcoming immunosuppression, which limits the effectiveness of current immunotherapies.
The Phase 1/2a study (GDFATHER) data from CatalYm demonstrate the potential of Visugromab as a novel therapeutic option for overcoming immune resistance in solid tumors. Study participants with NSCLC and UC demonstrated durable responses lasting over 16 and 15 months, respectively. Furthermore, 53% of responders achieved a deeper RECIST 1.1 response level compared to their original checkpoint inhibitor therapy.
The study also reported a remarkable rate of complete remissions, with 75% of complete response cases occurring in patients who had never achieved complete remission with previous treatments.
Beyond improving response quality, the neutralization of GDF-15 by Visugromab shows potential to enhance tolerability and efficacy in combination therapies with checkpoint inhibitors. Additionally, Visugromab demonstrated potential in addressing cancer-associated cachexia, contributing meaningfully to both early and late stages of cancer treatment. Cachexia, a severe complication of cancer, is characterized by significant weight loss, muscle atrophy, and loss of appetite, impacting both the quality of life and the patients' ability to tolerate cancer therapies.
The publication in Nature provides detailed insights into Visugromab's mechanism of action and its clinical impact on immune-mediated tumor control. [https://www.nature.com/articles/s41586-024-08305-z]