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FL-501 is a fully human, monoclonal antibody engineered to neutralize growth differentiation factor 15 (GDF-15), a cytokine implicated in cancer cachexia and a range of GDF-15-related diseases. It prevents GDF-15 from binding its receptor, resulting in reversal of immunosuppression in certain cancers and improvement of weight loss and muscle mass. FL-501 features enhanced target affinity and an extended plasma half-life compared to prior antibodies. Preclinical models demonstrate full restoration of body composition in cachexia, superior pharmacokinetics, and potential efficacy in immune stimulation and organ protection. Developed and currently being advanced by Leap Therapeutics, initially originated by Flame Biosciences and Adimab, FL-501 is planned for clinical trials in cachexia and other GDF-15-linked conditions including certain cancers[1][2][3][4][5][6][7][9].
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