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]
Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company's Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease