ImCheck Therapeutics announced plans to present updated results from its ongoing EVICTION study at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago. The presentation will highlight new data on ICT01, the company's novel γ9δ2 T-cell activator, when used in combination with azacitidine and venetoclax for treating newly diagnosed acute myeloid leukemia (AML).
The late-breaking abstract, titled "γ9δ2 T-cell (γδTC) activation and azacitidine-venetoclax (AV) for older/unfit adults with newly diagnosed (ND) acute myeloid leukemia (AML) induces high rates of complete remission (CR)," will be presented by Dr. Abhishek Maiti from the University of Texas MD Anderson Cancer Center on April 28, 2025.
Promising Efficacy in AML Treatment
The presentation will provide comprehensive data on efficacy, safety, pharmacodynamics, and dose selection of ICT01 in the combination regimen. According to ImCheck, the updated results build upon findings previously shared at the American Society of Hematology (ASH) Annual Meeting 2024, which demonstrated that ICT01 administered with azacitidine and venetoclax showed promising efficacy without compromising safety.
The combination therapy appears particularly significant for older or unfit adults with newly diagnosed AML, a patient population with historically limited treatment options and poor outcomes. AML is an aggressive blood cancer characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with normal blood cell production.
Dr. Naval G. Daver, one of the study authors, emphasized the importance of these findings: "The high complete remission rates we're observing with this novel combination approach could represent a meaningful advancement in how we treat AML in these vulnerable populations."
Innovative Mechanism of Action
ICT01 represents a new approach to cancer immunotherapy. It is a humanized, anti-BTN3A (CD277) monoclonal antibody that selectively activates γ9δ2 T cells, which play a crucial role in immune surveillance against malignancies and infections.
The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors and hematologic malignancies. When activated by ICT01, circulating γ9δ2 T cells migrate from circulation into tumor tissue and trigger an immunological cascade through the secretion of pro-inflammatory cytokines, including IFNγ and TNFα, further enhancing the anti-tumor immune response.
The EVICTION Clinical Trial
The EVICTION study is a first-in-human, dose-escalation and cohort-expansion clinical trial evaluating ICT01 across various advanced relapsed or refractory solid or hematologic cancers. The trial is structured in two parts:
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Part 1 (Phase I): Characterizes preliminary safety, tolerability, and pharmacodynamic activity of increasing doses of ICT01 as monotherapy in solid tumors (Group A) and hematologic tumors (Group B), and in combination with pembrolizumab in solid tumors (Group C).
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Part 2: Comprises randomized dose-optimizing and efficacy estimating expansion cohorts of monotherapy in ovarian cancer (Group D) and prostate cancer (Group E), as well as combination treatment in patients with AML (Group F), melanoma (Group G), urothelial cell carcinoma (Group H), and head-and-neck squamous cell carcinoma (Group I).
The AML cohort (Group F) is the focus of the upcoming AACR presentation, with data suggesting that the addition of ICT01 to the established azacitidine-venetoclax regimen may enhance treatment outcomes.
Clinical Implications and Future Directions
The standard of care for older or unfit AML patients has evolved in recent years with the approval of the azacitidine-venetoclax combination, which demonstrated improved survival compared to azacitidine alone. However, resistance and relapse remain significant challenges.
"Adding ICT01 to this backbone therapy represents a rational approach to potentially overcome resistance mechanisms by engaging the immune system through a completely different pathway," explained Dr. Pierre-Yves Dumas, another investigator on the study.
The high complete remission rates reported in the abstract title suggest that this triple combination could potentially address an important unmet need in AML treatment. Complete remission is a critical endpoint in AML therapy and is associated with improved survival outcomes.
ImCheck Therapeutics has indicated that the full poster will be available on their corporate website following the presentation at AACR. The company continues to advance ICT01 through clinical development, with the EVICTION trial (NCT04243499) ongoing at multiple sites globally.
About ImCheck Therapeutics
ImCheck Therapeutics is developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel superfamily of immunomodulators. The company's approach focuses on unlocking the power of γ9δ2 T cells, with potential applications across oncology, autoimmune, and infectious diseases.
The company's lead program, ICT01, has been advancing through clinical trials, demonstrating a unique mechanism of action that modulates both innate and adaptive immunity. ImCheck believes these "first-in-class" activating antibodies may deliver superior clinical outcomes compared to first-generation immunotherapy approaches, particularly in combination with immune checkpoint inhibitors and other immunomodulatory anti-cancer drugs.
Founded on the pioneering research of Prof. Daniel Olive from INSERM, CNRS, Institut Paoli Calmettes, and Aix-Marseille University, ImCheck benefits from expertise in γ9δ2 T cells and butyrophilins. The company is supported by leading U.S. and European investors and has established itself as an emerging player in the immuno-oncology field.
As the field of cancer immunotherapy continues to evolve, approaches like ICT01 that harness novel immune pathways may offer new hope for patients with difficult-to-treat malignancies like AML.
