ICT-01

ImCheck to Present Encouraging Interim Results in AML Patients from the EVICTION Trial at the 66th American Society of Hematology Annual Meeting Marseille, France, November 26, 2024, 11 am CET – ImCheck Therapeutics announced today it will present positive interim results from its ongoing open-label, randomized Phase I/II study EVICTION at the 66th American Society of Hematology (ASH) Annual Meeting. The poster presentation will provide data on the novel γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in older and/or unfit patients. ICT01 is a first-in-class anti-butyrophilin 3A monoclonal antibody designed to activate γ9δ2 T cells among other immune cell classes. Data to be presented at ASH demonstrate that ICT01, both at the low and high dose levels, was safe and very well tolerated, and generated high rates of complete remission (CR) and composite CR across different molecular subgroups, particularly in TP53-mutated AML, a population with an especially poor prognosis (link to the abstract on the ASH 2024 website).Details of the poster presentation are: 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 Authors: Abhishek Maiti, Pierre Yves Dumas, Pierre Peterlin, Daniel Morillo, Jose Torregrosa, Paul B. Koller, Maelle Mairesse, Patrick Brune, Emmanuel Valenitn, Aude De Gassart, Katrien Lemmens, Daniel Olive, Naval Daver, Stephan Braun, and Sylvain Garciaz. Date: Sunday, Dec. 8, 2024 Time: 6:00-8:00 pm Location: Halls G-H (San Diego Convention Center) The ASH poster will be available on ImCheck’s corporate website after the poster sessions have been opened. ***About the EVICTION Study EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical study of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options. Part 1 (Phase I) is designed to characterize the preliminary safety, tolerability, and pharmacodynamic activity of increasing doses of ICT01 as monotherapy (Group A: solid tumors; Group B: hematologic tumors) and in combination with pembrolizumab (Group C: solid tumors). Group A includes urothelial cell, breast, colorectal, gastric, melanoma, ovarian, prostate, and pancreatic cancer patients, Group B includes acute myeloid leukemia, follicular lymphoma, and diffuse large B cell lymphoma patients. Group C includes urothelial cell, head-and-neck squamous cell carcinoma, melanoma, and non-small cell lung cancer patients. Part 2 is a Phase II cohort expansion study of monotherapy and combination treatment of patients with melanoma, urothelial cell, epithelial ovarian, prostate or head-and-neck squamous cell carcinoma, and acute myeloid leukemia. More information on the EVICTION study can be found at clinicaltrials.gov (NCT04243499). About ICT01ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates γ9δ2 T cells, which are part of the innate immune system that is responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia & lymphoma) and also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. As demonstrated by data presented at past AACR, ASCO, ASH, ESMO and SITC conferences, ICT01 selectively activates circulating γ9δ2 T cells leading to migration of γ9δ2 T cells out of the circulation and into the tumor tissue activating tumor-resident γ9δ2 T cells and other immune effector cells with subsequent secretion of inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in vitro and in vivo as well as in patients across several indications. About IMCHECK THERAPEUTICS ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel super-family of immunomodulators. As demonstrated by its lead clinical-stage program ICT01, which has a mechanism of action to simultaneously modulate innate and adaptive immunity, ImCheck's “first-in-class” activating antibodies may be able to produce superior clinical results as compared to the first-generation of immune checkpoint inhibitors and, when used in combination, to overcome resistance to this group of agents. In addition, ImCheck’s antagonist antibodies are being evaluated as potential treatments for a range of autoimmune and infectious diseases. ImCheck benefits from support from Prof. Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille University), a worldwide leader in γ9δ2 T cells and butyrophilins research, as well as from the experience of an expert management team and from the commitment of leading US and European investors. For further information: https://www.imchecktherapeutics.com/ Press contacts: US and EU Trophic CommunicationsGretchen Schweitzer +49 (0) 172 861 8540imcheck@trophic.eu FranceATCG PARTNERSCéline Voisin+33 (0)6 62 12 53 39imcheck@atcg-partners.com Attachment PR in English