About ICT01

Anti-BTN3A mAb that selectively activates γ9δ2 T cells for IO

ICT01 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 3 isoforms of BTN3A targeted by ICT01 are overexpressed on a number of solid tumors (e.g., bladder, colorectal, melanoma, ovarian, pancreatic, lung) and hematologic cancers (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.

ImCheck has presented encouraging results from the ongoing EVICTION trial in oral presentations at major medical conferences since 2021, including AACR, ESMO and SITC, demonstrating the safety of ICT01 and its potent mechanism of action leading to activation, migration and tumor infiltration of circulating γ9δ2 T cells, CD8 T cells & NK cells and initial tumor responses.

Mechanism of action

ImCheck Therapeutics published on Oct 20, 2021, the development results of ICT01 in the medical journal Science Translational Medicine in the article “Development of ICT01, a first-in-class, anti-BTN3A antibody for activating Vγ9Vδ2 T cell-mediated anti-tumor immune response”

This publication has been selected by the AACR journal Cancer Immunology Research Deputy and Senior Editors to be featured in the “What We’re Reading” section of the January issue of CIR

EVICTION (EValuation of ICT01 in Immuno-ONcology) Study

ImCheck is conducting EVICTION, a Phase I/IIa, first-in-human, open-label clinical trial to characterize the safety, tolerability and activity of ICT01 as monotherapy and in combination with pembrolizumab in patients with advanced, relapsed/refractory cancer, including both solid tumors and hematologic cancers.

The trial is an international, multicenter study currently enrolling patients at major cancer centers in France, Belgium, Germany, Spain, the UK, and the US.

Part 1 is a basket trial designed to characterize the preliminary safety, tolerability, and pharmacodynamic activity of ICT01 as monotherapy (Group A: solid tumors; Group B: hematologic tumors) and in combination with pembrolizumab (Group C: solid tumors). Group A included bladder, breast, colorectal, gastric, melanoma, ovarian, prostate, and pancreatic cancer patients, Group B included acute myeloid leukemia, acute lymphocytic leukemia, follicular lymphoma, and diffuse large B cell lymphoma patients, and Group C included bladder, head and neck squamous cell carcinoma, melanoma, and non-small cell lung cancer patients. Basket trials are a clinical trial design that allows new drugs to be tested rapidly in a range of indications, providing initial data on multiple parameters that can contribute to an accelerated development timeline.

Part 2 of the trial is a Phase II cohort expansion in selected indications based on Part I of the study with both monotherapy and combination settings. First indications selected for this Phase II part are ovarian cancer and Head and Neck Squamous Cell Carcinoma (HNSCC).

For more information, please refer tohttps://www.clinicaltrials.gov/ct2/show/NCT04243499.

Data presented at ESMO Annual Meeting 2022:

Oral presentation: The Combination of ICT01, a γ9δ2 T cell-activating mAb, plus Pembrolizumab Induces a Broad Antitumor Immune Response and Disease Control in Patients with CPI-Failure Melanoma, NSCLC and Bladder Cancer: EVICTION Trial

Data presented at AACR Annual Meeting 2022:

Poster: ICT01, an anti-butyrophilin 3A targeted mAb activating γ9δ2 T cells, induces immune remodeling of the tumor microenvironment and clinical responses in combination with pembrolizumab in patients with advanced solid tumors who failed prior checkpoint inhibitor therapy: EVICTION Trial

Data presented at SITC Annual Meeting 2021:

Oral presentation at ESMO Annual Meeting 2021:

Coordinated Activation of Antitumor Responses of γ9δ2 and CD8 T Cells by Targeting BTN3A with ICT01 in Patients with Solid Tumors: EVICTION Trial

Oral presentation at AACR Annual Meeting 2021:

Activation of the anti-tumor immune response of γ9δ2 T cells in patients with solid or hematologic malignancies with ICT01, a first-in-class, monoclonal antibody targeting Butyrophilin 3A: The EVICTION study

Posters presented at SITC Annual Meeting 2020:

EVICTION-2 (EValuation of ICT01 in Immuno-ONcology) Study 2

EVICTION-2 is a first-in-human, dose escalation (Part 1) and cohort expansion (Part 2) clinical trial evaluating ICT01 in combination with low dose subcutaneous IL-2. The trial’s objective is to demonstrate the combination’s ability to selectively expand the number of γ9δ2 T cells in patients with solid tumors (prostate, pancreatic, ovarian, or colorectal cancer).

For more information, please refer tohttps://www.clinicaltrials.gov/ct2/show/NCT04243499.

ICT01 Clinical Advisory Board

Marc Bonneville, DVM, PhD
VP in charge of scientific and medical affairs Institut Merieux
Scientific and Medical director, deputy General Manager Fondation Mérieux
Former Director of the INSERM Cancer Research Center Nantes

Richard Buller, MD, PhD
Independent Consultant, Oncology Diagnostic and Drug Development Consulting, LLC
Former VP Oncology Clinical Development, Pfizer

Johann de Bono, MBChB, FRCP, MSc, PhD, FMedSci, FRSB
Regius Professor of Cancer Research
Professor in Experimental Cancer Medicine and Honorary Consultant Medical Oncologist,
Director of the Drug Development Unit & Head of Prostate Cancer Targeted Therapy Group
The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

Jean Jacques Fournié, PhD
Director of Research exceptional grade senior researcher at the CNRS Cancer Research Center of Toulouse
Former founding Director of Cancer Research Center of Toulouse

Richard D. Lopez, MD
Associate Professor, Division of Hematologic Malignancies & Cellular Therapy Duke University

Patricia LoRusso, MD
Professor of Medicine (Medical Oncology), Associate Center Director for Innovative Medicine at Yale Cancer Center

Aurélien Marabelle, MD, PhD
Clinical Director, Cancer Immunotherapy Program
Director, Translational Research Laboratory in Immunotherapy
Gustave Roussy, Paris

Daniel Olive, MD, PhD
Head of the Cancer Research Center Marseille
Professor of Immunology and Head of the Oncology Research Program at Aix Marseille University
Scientific Founder of ImCheck

Jeffrey S. Weber, MD, PhD
Laura and Isaac Perlmutter Professor of Oncology
Deputy Director, Perlmutter Cancer Center,
Codirector, Melanoma Research Program, NYU Langone

Profiles of our Clinical Advisory Board members