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GL-IL2-138 is a first-in-class, orally administered small molecule RNA agent designed to modulate natural production of interleukin-2 (IL-2) at the mRNA level, thereby regulating immune cell output of endogenous IL-2 protein. Unlike traditional recombinant IL-2 protein therapies that require intravenous administration and are limited by systemic toxicity, GL-IL2-138 binds to endogenous IL-2 mRNA in immune cells, enabling controlled, physiologic modulation of IL-2. This agent is intended to provide potent immunomodulatory activity (capable of both upregulation and downregulation of immune responses) with higher tolerability, oral dosing, and potential applicability across a broad range of diseases including oncology, autoimmune, and neurodegenerative conditions. The compound was developed by Genetic Leap and is entering a phase 1 clinical trial following Investigational New Drug (IND) clearance by the FDA in July 2025[1][3][8][10][11][12].
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