ImCheck Therapeutics to Present Promising ICT01 AML Data at ASH 2025, Showing High Remission Rates in First-Line Treatment
核心洞察
ImCheck Therapeutics will present data from the EVICTION Phase I/II study at ASH 2025, highlighting high remission rates and overall survival for ICT01 combined with azacitidine and venetoclax in newly diagnosed AML patients.
ICT01 is a first-in-class humanized monoclonal antibody that selectively activates γ9δ2 T cells by targeting BTN3A (搜索), demonstrating a unique mechanism of action that modulates both innate and adaptive immunity.
The EVICTION study is evaluating ICT01 across multiple cancer types, with the AML cohort focusing on older or unfit patients with newly diagnosed acute myeloid leukemia.
ImCheck Therapeutics announced it will present promising clinical data for its first-in-class immunotherapy ICT01 at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, Florida. The oral presentation will showcase high remission rates and overall survival observed in the company's EVICTION Phase I/II study evaluating ICT01 in combination with azacitidine and venetoclax for older or unfit patients with newly diagnosed acute myeloid leukemia (AML).
Novel Immunotherapy Mechanism Shows Promise in AML
ICT01 represents a breakthrough approach to cancer immunotherapy as a humanized, anti-BTN3A (搜索) (CD277 (搜索)) monoclonal antibody that selectively activates γ9δ2 T cells. These specialized immune cells are responsible for immunosurveillance of malignancy and infections, offering a unique therapeutic target. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors, including melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer, as well as hematologic malignancies such as leukemia and lymphomas.
The mechanism of action involves BTN3A (搜索) activation, which is essential for triggering the anti-tumor immune response of γ9δ2 T cells. As demonstrated in previous conference presentations at AACR, ASCO, ASH, ESMO and SITC, ICT01 selectively activates circulating γ9δ2 T cells, leading to their migration from circulation into tumor tissue and triggering a downstream immunological cascade through secretion of pro-inflammatory cytokines, including IFNγ and TNFα.
EVICTION Study Design and Scope
The EVICTION study (NCT04243499) is a comprehensive first-in-human clinical trial with a dose-escalation Phase I component (Part 1) and cohort-expansion Phase II component (Part 2). Part 1 characterizes the preliminary safety, tolerability, and pharmacodynamic activity of increasing doses of ICT01 as monotherapy in solid tumors (Group A) and hematologic tumors (Group B), as well as in combination with pembrolizumab for solid tumors (Group C).
Part 2 comprises randomized dose-optimizing and efficacy estimating expansion cohorts across multiple cancer types. These include monotherapy cohorts for ovarian cancer (Group D) and prostate cancer (Group E), as well as combination treatment cohorts for AML (Group F), melanoma (Group G), urothelial cell carcinoma (Group H), and head-and-neck squamous cell carcinoma (Group I).
ASH Presentation Details
The oral presentation, titled "γ9δ2 T-cell (γ9δ2TC) activation with ICT01 and azacitidine-venetoclax (Aza-Ven) induces high rates of remission and overall survival in patients with newly diagnosed (ND) acute myeloid leukemia (AML): Results from the phase 1/2 study eviction," will be delivered by Dr. Sylvain Graciaz from Institut Paoli-Calmettes in Marseille, France.
The presentation is scheduled for Sunday, December 7, 2025, from 5:15 p.m. to 5:30 p.m. ET in the OCCC Chapin Theater (320) as part of Session 616: Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Immunotherapy and chemotherapy combinations in AML.
Company Development and Strategic Partnership
ImCheck Therapeutics is developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel superfamily of immunomodulators. The company's approach aims to unlock the power of γ9δ2 T cells with potential to transform treatments across oncology, autoimmune, and infectious diseases.
The company benefits from pioneering research by Prof. Daniel Olive from INSERM, CNRS, Institut Paoli-Calmettes, and Aix-Marseille University, recognized as a global leader in γ9δ2 T cells and butyrophilins. ICT01 has been advancing to late-stage trials, demonstrating a unique mechanism of action that modulates both innate and adaptive immunity.
In a significant strategic development, Ipsen and ImCheck entered into a definitive share purchase agreement on October 22, 2025, under which Ipsen will acquire all issued and outstanding shares of ImCheck. The transaction is anticipated to close by the end of Q1 2026, representing a major validation of ImCheck's innovative immunotherapy platform.