FL-501 / Leap Therap - LARVOL DELTA

FL-501 is a potential best in class GDF-15 inhibitor with extended half-life and potent anti-cachexia activity in preclinical models (AACR 2025) - "In this therapeutic model, mice were treated with cisplatin (5 mg/kg) alone or in combination with either FL-501 or ponsegromab...Further, the targeted inhibition of GDF-15 with FL-501 was able to effectively reverse characteristics of cancer cachexia in multiple pre-clinical models. Taken together, these findings support the continued evaluation of FL501 and its progression into the clinic."

Preclinical • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GDF15

Leap Therapeutics to Present Preclinical Data of FL-501, a Novel GDF-15 Neutralizing Antibody, at the AACR 2025 Annual Meeting (PRNewswire) - "'We look forward to progressing the development of FL-501 and bringing the asset into the clinic in 2026.'....Key Findings: In humanized FcRn mouse studies, FL-501 demonstrated a 2-3-fold longer half-life and 50% reduced clearance compared to its wild-type precursor and ponsegromab; In mouse cachexia models using GDF-15-overexpressing colorectal cancer cells, FL-501 fully restored body composition, comparably or better than clinical-stage antibodies visugromab and ponsegromab; In a non-small cell lung cancer patient-derived xenograft model, FL-501 effectively countered cisplatin-induced weight loss, restoring body weight, composition, and condition scores; These findings confirm GDF-15's role in cachexia and support FL-501's advancement in development."

New trial • Preclinical • Cachexia • Colorectal Cancer • Non Small Cell Lung Cancer

Presenting preclinical FL-501 data at the 2025 American Association for Cancer Research (AACR) Annual Meeting. (GlobeNewswire) - "Preclinical data from FL-501, a potential best-in-class monoclonal antibody designed to neutralize GDF-15 to treat patients with cachexia and other GDF-15-driven diseases, will be featured during a poster session at the 2025 AACR Annual Meeting taking place April 25-30 in Chicago. In addition, manufacturing and non-clinical development continues with the goal of beginning a clinical trial in 2026."

New trial • Preclinical • Cachexia • Solid Tumor

Leap Therapeutics Acquires Flame Biosciences (PRNewswire) - "Leap Therapeutics, Inc....announced that the companies have entered into a definitive merger agreement pursuant to which Leap has acquired Flame and its assets, including FL-301, its clinical stage anti-Claudin18.2 monoclonal antibody, FL-302, its preclinical anti-Claudin18.2/CD137 bispecific monoclonal antibody, FL-501, its preclinical anti-GDF15 monoclonal antibody, and net cash of approximately $50 million as of December 31, 2022. The combined company will...remain focused on advancing DKN-01, Leap's anti-DKK1 monoclonal antibody, in Phase 2 clinical trials in gastric cancer, endometrial cancer, and colorectal cancer patients. The total cash balance of the combined company as of December 31, 2022 was approximately $115 million, expected to be sufficient to fund Leap's planned operating expenses and development plans for DKN-01, FL-301, and the preclinical programs to mid-2025."

Financing • M&A • Oncology