Core Viewpoint - Cue Biopharma, Inc. is advancing its lead asset CUE-401, a novel bifunctional therapeutic designed to treat autoimmune and inflammatory diseases, with a poster presentation scheduled at the World Immune Regulation Meeting in March 2026, showcasing new in vitro data that supports its therapeutic potential [1][2]. Group 1: CUE-401 Presentation Details - The poster presentation will be held on March 12, 2026, by Natasha M. Girgis, Director of Translational Pharmacology, focusing on CUE-401's ability to inhibit proinflammatory immune cells through TGF-beta [2]. - The session is categorized under Autoimmunity and Innate Immunity, highlighting the significance of CUE-401 in addressing autoimmune conditions [2]. Group 2: Mechanism of Action - CUE-401 operates through three mechanisms: direct regulation of proinflammatory pathways via TGF-beta, expansion of regulatory T cells (Tregs) through IL-2, and conversion of conventional CD4+ T cells into FOXP3+ induced Tregs [4]. - The therapeutic effects of CUE-401 include suppression of proinflammatory cytokines in CD4+ T effector memory cells and prevention of activated B cells from differentiating into plasma cells, thereby limiting antibody production [3]. Group 3: Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing injectable biologics that selectively engage and modulate disease-specific T cells, aiming to harness the body's immune system without broad systemic effects [5]. - The company utilizes its proprietary Immuno-STAT® platform to create therapeutics like CUE-401, which is designed to act as a master switch for Treg differentiation and immune tolerance [5].

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]

Core Insights - MiNK Therapeutics has received a non-dilutive grant from the National Institute of Allergy and Infectious Diseases (NIAID) to support the development of its allogeneic invariant natural killer T (iNKT) cell therapy platform for preventing and treating graft-versus-host disease (GvHD) in high-risk hematopoietic stem cell transplantation (HSCT) settings [1][2] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic iNKT cell therapies and precision-targeted immune technologies [4] - The company's lead asset, AGENT-797, is an off-the-shelf iNKT cell therapy currently in clinical development for GvHD, solid tumors, and critical pulmonary immune collapse [4] - MiNK is advancing a pipeline of T cell receptor (TCR)-based therapies and neoantigen discovery tools aimed at enabling tumor- and tissue-specific immune activation [4] Research and Development - The collaboration with the University of Wisconsin aims to leverage expertise in transplant immunology to enhance the efficacy of iNKT cells in managing GvHD while preserving the patient's ability to fight infections [3] - iNKT cells are recognized for their potential to regulate immune responses, promote tissue repair, and suppress inflammatory pathways, making them suitable for addressing GvHD complications [2][3] Market Need - Nearly 50% of patients undergoing allogeneic stem cell transplants are at risk for GvHD, highlighting a significant unmet medical need in this area [2]