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Leap Therapeutics Unveils Promising Preclinical Data of FL-501 at AACR 2025

As the American Association for Cancer Research (AACR) Annual Meeting approaches, Leap Therapeutics, a pioneering biotechnology firm, is making waves with the announcement of crucial preclinical data regarding their innovative candidate, FL-501. The event, scheduled from April 25 to April 30, 2025, in Chicago, Illinois, is a prominent venue for researchers and companies in the field of cancer research.

What is FL-501?

FL-501 is positioned as a potential leading monoclonal antibody specifically designed to neutralize growth differentiation factor 15 (GDF-15). This particular cytokine has been linked to various unfavorable health conditions, one of which is cancer cachexia—a debilitating syndrome that leads to severe weight loss, muscle atrophy, and significant overall decline in quality of life for cancer patients.

Dr. Jason Baum, the Chief Scientific Officer at Leap Therapeutics, elaborated on the gravity of cancer cachexia, stating, “It is a devastating and potentially life-threatening condition. Current treatment options are ineffective, making the development of FL-501 even more crucial.” The encouraging results from preclinical studies reinforce FL-501's potential as a game-changer in managing this syndrome.

Key Findings from Preclinical Studies

The preclinical studies exhibited several vital findings:

• - In controlled experiments using humanized FcRn mice, FL-501 demonstrated an impressive double to triple increase in half-life and a clear reduction in clearance rates compared to traditional antibodies.
• - In models integrating GDF-15-overexpressing colorectal cancer cells, FL-501 successfully restored body composition significantly, better or on par with currently available clinical antibodies such as ponsegromab.
• - Notably, in a patient-derived xenograft model for non-small cell lung cancer, FL-501 reversed weight loss induced by cisplatin treatment, restoring both body weight and composition effectively.

These results underscore the innovative nature of FL-501 and serve to confirm the prominent role of GDF-15 in cachexia, paving the way for its further clinical investigation.

Presentation at AACR 2025

Leap Therapeutics is keenly looking forward to showcasing these findings at AACR 2025. The poster presentation, entitled “FL-501 is a potential best in class GDF-15 inhibitor with extended half-life and potent anti-cachexia activity in preclinical models,” will take place on April 29, 2025. With a focus on experimental and molecular therapeutics, the session will provide an excellent platform to disseminate the findings and gather feedback from experts in the field.

Future Perspectives

FL-501 not only opens new avenues in the treatment of cachexia but may also help mitigate immunosuppression in cancers that correlate high GDF-15 levels with reduced survival rates. The ongoing collaboration with Adimab enhances the development prospects for FL-501 as the company gears up for clinical trials slated for 2026.

Leap Therapeutics continues to push the boundaries of biopharmaceuticals in the effort to provide effective treatments for cancer and related syndromes, signaling a promising future for FL-501 and its role in cancer cachexia management. As the AACR 2025 meeting unfolds, all eyes will be on Leap and the potential impact of their innovative treatment strategy on patient care and outcomes.

For more insights on Leap Therapeutics and their groundbreaking work, visit Leap Therapeutics.