Core Insights - Cue Biopharma, Inc. has received positive Pre-IND feedback from the FDA regarding its lead autoimmune asset, CUE-401, a first-in-class bispecific molecule designed to induce and expand regulatory T cells (Tregs) in vivo [1][2] - CUE-401 utilizes the combined activities of transforming growth factor beta (TGF-β) and a modified variant of interleukin 2 (IL-2) to potentially provide durable immune rebalance and tolerance for various autoimmune diseases [2][4] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics that selectively engage and modulate disease-specific T cells for autoimmune disease treatment [1][8] - The company’s proprietary platform, Immuno-STAT™, aims to harness the body's intrinsic immune system without the adverse effects of broad systemic immune modulation [8] Product Details - CUE-401 is engineered to enhance the Treg induction capacity of TGF-β combined with IL-2 signaling, which is believed to improve the quality and stability of Tregs [5][6] - The design of CUE-401 allows for "conditional binding," which minimizes off-target activity and simplifies manufacturing processes [6] Mechanism of Action - CUE-401 acts as a master switch to convert autoreactive effector T cells into stable, induced T-regulatory cells (iTregs), establishing a 'tolerance positive feedback loop' that increases nonspecific Treg populations while reducing autoreactive T cells [7]

Research and development expenses were $7.2 million and $10.9 million for the three months ended December 31, 2024 and 2023, respectively. The decrease was primarily due to decreases in both drug substance manufacturing and clinical trial costs. BOSTON, March 31, 2025 (GLOBE NEWSWIRE) -- - Cue Biopharma, Inc. (NASDAQ:CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of cancer and au ...