Cue Biopharma Announces Preclinical Safety and Tolerability Data for CUE-401 for the Treatment of Autoimmune and Inflammatory Diseases

Core Insights - Cue Biopharma, Inc. announced promising preclinical safety and tolerability data for CUE-401, its lead autoimmune asset, indicating no adverse events were observed in two non-GLP studies [1][2] - The company is optimistic about CUE-401's potential as a first-in-class bifunctional tolerogenic agent for autoimmune diseases and plans to file an investigational new drug (IND) application in the coming months [2] Study Design and Key Data Highlights - Two non-GLP studies were conducted in mice (n=24) and non-human primates (NHPs) (n=6) to assess the safety and tolerability of CUE-401 using a step-up dosing schedule [3] - CUE-401 was administered intravenously with escalating doses of 1 mg/kg, 3 mg/kg, and 10 mg/kg, all of which were well tolerated [6] - In the core study, animals received escalating doses of 0.1 mg/kg, 0.3 mg/kg, and 1 mg/kg, with no adverse observations reported [6] About CUE-401 - CUE-401 is a novel bifunctional therapeutic that combines a TGF-beta breathing-mask moiety with a clinically validated interleukin 2 (IL-2) mutein, designed to promote immune regulation and tolerance through multiple mechanisms [4][5] - The therapeutic aims to regulate proinflammatory mechanisms, expand existing Tregs, and convert conventional CD4+ T cells into FOXP3+ induced Tregs [4] About Cue Biopharma - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing injectable biologics to selectively engage and modulate disease-specific T cells [5] - The company's proprietary platform, Immuno-STAT™, aims to harness the body's immune system without broad systemic immune modulation [5]