About ICT01

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 results from Phase I of the EVICTION trial in oral presentations at major medical conferences in 2021, including AACR, ESMO and SITC, demonstrating ICT01’s safety, its powerful 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).

More information on the  EVICTION trial can be found at https://www.clinicaltrials.gov/ct2/show/NCT04243499.

Data presented at ESMO Annual Meeting 2022:

Data presented at AACR Annual Meeting 2022:

Data presented at SITC Annual Meeting 2021:

Oral presentation at ESMO Annual Meeting 2021:

Oral presentation at AACR Annual Meeting 2021:

Posters presented at SITC Annual Meeting 2020:

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

ImCheck’s first clinical trial started in 2020 - Now in Phase II cohort expansion

Paul Frohna MD, PhD, PharmD

Chief Medical Officer

ImCheck’s first clinical trial started in 2020 - Now in Phase II cohort expansion

As a first-in-class, immune system-activating mAb, we are encouraged to see rapid and potent dose-dependent activity of ICT01 without any safety concerns in the patients treated to date.
The latest data from the EVICTION trial support our confidence that ICT01 has significant potential to provide meaningful therapeutic effects, particularly in patients with advanced, metastatic solid tumors that did not respond to prior checkpoint inhibitor therapy.