Positive Results from CatalYm’s GDFATHER Trial
CatalYm’s “GDFATHER” Phase 1/2a trial has shown promising results for its lead candidate, visugromab, in combination with nivolumab, an anti-PD-1 antibody. The trial included cohorts of patients with non-small cell lung cancer (NSCLC), urothelial cancer (UC), hepatocellular carcinoma (HCC), and an additional biomarker cohort.
Mechanism of Action
Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a protein produced by tumors that suppresses the immune system’s ability to fight cancer. By blocking GDF-15, visugromab aims to overcome this resistance and enhance the effectiveness of immunotherapies.
Clinical Results
The trial data demonstrated that the combination of visugromab and nivolumab induced deep and durable anti-tumor activity in patients who had previously failed anti-PD-1/PD-L1 therapies. Notably, over half of the responders achieved a response level not previously achieved with their prior anti-PD-(L)1 treatment.
This suggests that visugromab’s ability to block GDF-15 leads to a deeper and more sustained remission than other cancer immunotherapies.
Safety and Tolerability
The combination of visugromab and nivolumab was well-tolerated, with no significant safety concerns reported. This favorable safety profile is critical for ensuring that patients can receive the treatment for an extended period without experiencing adverse effects.
Future Development Plans
CatalYm is planning a broad Phase 2b development program to investigate the potential of visugromab further. This program will explore the optimal use of visugromab in combination with standard-of-care treatments and in earlier lines of therapy.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
