CUE-401 / Cue Biopharma - LARVOL DELTA

Business, Financial and Leadership Highlights (The Manila Times) - "CUE-221...Phase 2 data readout in Chronic Spontaneous Urticaria anticipated by the end of the third quarter of 2026...CUE-401: Company anticipates submitting an IND to the FDA and initiating a Phase 1 clinical study by year-end 2026."

IND • New P1 trial • P2 data • Chronic Spontaneous Urticaria • Food Hypersensitivity • Immunology

CUE-401 is a Novel TGF-beta/IL-2 Fusion Protein that Induces Selective Expansion of Functional, Stable FOXP3+ Tregs for Treatment of Autoimmunity (IMMUNOLOGY 2026) - "Together, these results demonstrate that CUE-401 induces functional, stable Tregs and promotes control of diverse inflammatory responses, supporting the therapeutic potential of CUE-401 to restore immune balance for the treatment of autoimmune and inflammatory diseases."

Graft versus Host Disease • Immunology • Inflammation • CD4 • FOXP3 • IL2 • TGFB1

Cue Biopharma to Present New Preclinical Data on Lead Autoimmune and Inflammatory Disease Candidate CUE-401 at IMMUNOLOGY2026 (GlobeNewswire) - "As part of the presentation, Dr. Girgis will discuss new in vivo data that supports CUE-401’s ability to induce FOXP3+ antigen-specific induced T regulatory cells (iTregs) from FOXP3- conventional CD4+ T cells through the coordinated delivery of TGF-β and interleukin-2 (IL-2) signals. This new and promising preclinical data supports CUE-401’s therapeutic potential to restore immune homeostasis in autoimmune and inflammatory diseases."

Preclinical • Immunology • Inflammation

Advanced research and development of CUE-401 for IND (Investigational New Drug) readiness (GlobeNewswire) - "Conducted toxicology and pharmacology studies and announced preclinical safety and tolerability data. In two non-GLP studies, CUE-401 was well tolerated with no adverse events observed. Proof-of concept studies reinforce promising preclinical profile and therapeutic potential of CUE-401. Presented in vivo and in vitro data that demonstrate the therapeutic potential of CUE-401 to restore immune balance for the treatment of autoimmune and inflammatory diseases at the World Immune Regulation Meeting (WIRM)....Company plans to announce Virtual R&D Day event highlighting CUE-401...within the next couple of weeks."

Preclinical • Immunology • Inflammation

Cue Biopharma Announces Preclinical Safety and Tolerability Data for CUE-401 for the Treatment of Autoimmune and Inflammatory Diseases (GlobeNewswire) - "Murine Study (n=24, 12 males, 12 females):...All dose levels were well tolerated, and no adverse events were observed....NHP Study (n=6, 3 males, 3 females):...All dose levels were well tolerated in the core study with no adverse observations....Repeat dosing of CUE-401 at 1 mg/kg was better tolerated than the repeat dosing at 3 mg/kg....'We look forward to sharing further scientific data and details on the planned investigational new drug (IND) filing for CUE-401 in the upcoming months'."

IND • Preclinical • Immunology • Inflammation

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 (GlobeNewswire) - "Cue Biopharma...announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA). The FDA reviewed the first-in-human trial design, including the Company’s plan for dose escalation, proposed populations and safety monitoring plan. On the basis of the FDA feedback, the Company, intends to file an IND pending completion of final IND enabling studies. CUE-401 is the Company’s lead autoimmune asset, a first-in-class bispecific fusion protein/molecule designed to induce and expand regulatory T cells (Tregs) in vivo through the co-activity of transforming growth factor beta (TGF-β) and a modified variant of interleukin 2 (IL-2)."

FDA event • Immunology

Cue Biopharma Reports First Quarter 2025 Financial Results and Recent Business Highlights (GlobeNewswire) - "Upcoming Event: Novel Biologics Portfolio Virtual Event planned for May 15, 2025 at 11 AM ET: Cue Biopharma’s virtual event will feature two key opinion leaders (KOLs): Richard DiPaolo, PhD (Saint Louis University) and Andrew Cope, MD, PhD (Centre for Rheumatic Diseases, King's College London). The event will highlight new preclinical data for CUE-401...and include key updates on the CUE-100 series clinical oncology programs."

Clinical • Preclinical • Immunology • Inflammation • Oncology

Cue Biopharma to Present at the Federation of Clinical Immunology Societies (FOCIS) 2023 Annual Meeting (GlobeNewswire) - "Cue Biopharma’s collaborator, Dr. DiPaolo, will discuss in vitro and in vivo data demonstrating the potential of CUE-401, the company’s novel bispecific protein designed to induce and expand regulatory T cells (Tregs) for the treatment of T-cell mediated autoimmune and inflammatory diseases. The ability of CUE-401 to effectively induce de novo FOXP3-expressing iTregs from both mouse and human CD4+ T cells – while also expanding existing Tregs – and suppress autoimmune inflammation represents a novel therapeutic approach."

Preclinical • Immunology

CUE-401: A Novel IL-2/TGF-beta Fusion Protein for the Induction of CD4+ FOXP3+ Regulatory T Cells (FOCIS 2023) - No abstract available

Immunology • CD4 • FOXP3 • IL2 • TGFB1

Inducing/expanding Tregs in vivo to suppress autoimmunity using a new bispecific therapeutic containing IL-2 and TGFβ. (P902) (IMMUNOLOGY 2023) - "Finally, CUE-401 induced iTregs were effective at suppressing organ specific autoimmunity. These studies identify a new injectable therapeutic, and new approach to induce and expand Tregs in vivo to suppress autoimmunity and other inflammatory diseases."

Preclinical • Inflammation • CD4 • FOXP3 • IL2 • TGFB1

Cue Biopharma Enters into a Strategic Collaboration and Option Agreement with Ono Pharmaceutical for CUE-401 (GlobeNewswire) - "Cue Biopharma, Inc...announced today a collaboration and option agreement with Ono Pharmaceutical Co., Ltd. (“Ono”), for CUE-401, a bispecific protein designed to induce and expand regulatory T cells (Tregs) for the treatment of autoimmune and inflammatory diseases....Under the terms of the agreement, Ono will pay Cue Biopharma an upfront payment and fully fund all research activities related to CUE-401 through a specified option period."

Licensing / partnership • Graft versus Host Disease • Immunology • Inflammation • Inflammatory Bowel Disease

[VIRTUAL] CUE-401: A novel IL-2/TGF-beta fusion protein for the induction of CD4+ FOXP3+ regulatory T cells (FOCIS 2021) - "In conclusion, we have engineered a novel, bispecific biologic capable of potently inducing Tregs in vitro and in vivo in settings where TCR-stimulation is provided in the context of the developing or existing autoimmune milieu. Bias toward iTreg induction rather than manipulation of the limited number and repertoire of existing nTregs may provide significant opportunities for the treatment of patients with various autoimmune diseases as well as treatment of GVHD."

Late-breaking abstract • Graft versus Host Disease • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CD4 • FOXP3 • IL2 • TGFB1

Cue Biopharma to Present at the 2021 Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting (GlobeNewswire) - "Cue Biopharma, Inc...announced today it will give a presentation at the 2021 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, which is being held virtually from June 8-11, 2021...In vivo data show that CUE-401 can effectively induce FOXP3-expressing iTregs from T cells obtained from healthy donors as well as patients suffering from rheumatoid arthritis and inflammatory bowel diseases."

Preclinical • Inflammatory Bowel Disease • Rheumatoid Arthritis