ImCheck Therapeutics announced encouraging interim results from its EVICTION trial, evaluating ICT01 in combination with azacitidine and venetoclax for treating newly diagnosed acute myeloid leukemia (AML) in older and/or unfit patients. The data, to be presented at the 66th American Society of Hematology (ASH) Annual Meeting, showcase the potential of ICT01, a first-in-class anti-butyrophilin 3A monoclonal antibody, in improving outcomes for this challenging patient population.
ICT01: A Novel Approach to AML Treatment
ICT01 is designed to activate γ9δ2 T cells, a component of the innate immune system crucial for immunosurveillance of malignancies. By targeting butyrophilin 3A, ICT01 aims to stimulate anti-tumor immune responses. The EVICTION trial (NCT04243499) is a Phase I/II study assessing the safety, tolerability, and efficacy of ICT01 in patients with advanced relapsed or refractory solid or hematologic cancers.
Promising Interim Results in AML Patients
The interim results from the AML cohort of the EVICTION trial indicate that ICT01, at both low and high dose levels, was safe and well-tolerated. Notably, the combination therapy achieved high rates of complete remission (CR) and composite CR across various molecular subgroups. Of particular interest is the observed efficacy in TP53-mutated AML, a subgroup known for its poor prognosis. These patients typically exhibit resistance to standard therapies, making the observed responses with ICT01 particularly significant.
Details of the ASH Presentation
The poster presentation at ASH will provide a comprehensive overview of the interim data. Key details include:
- Abstract Title: "The novel γ9δ2 T-cell activator ICT01 combined with azacitidine-venetoclax shows high rates of complete remission in older/unfit adults with newly diagnosed acute myeloid leukemia: interim results from Phase 1 study EVICTION"
- Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II
- Abstract Number: 2876
- Presenter: Abhishek Maiti, University of Texas MD Anderson Cancer Center
- Date: Sunday, Dec. 8, 2024
- Time: 6:00-8:00 pm
- Location: Halls G-H (San Diego Convention Center)
Mechanism of Action and Clinical Implications
ICT01's mechanism involves selectively activating circulating γ9δ2 T cells, leading to their migration into tumor tissue and subsequent activation of tumor-resident immune effector cells. This process results in the secretion of inflammatory cytokines, such as IFNγ and TNFα, further augmenting the anti-tumor immune response. Preclinical and clinical data have demonstrated ICT01's anti-tumor activity across several indications.
ImCheck Therapeutics is focused on developing immunotherapeutic antibodies targeting butyrophilins to modulate both innate and adaptive immunity. The company believes that ICT01 and its other "first-in-class" activating antibodies have the potential to produce superior clinical results compared to first-generation immune checkpoint inhibitors and overcome resistance to these agents when used in combination.
