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 for malignancy and infection. The 3 isoforms of BTN3A targeted by ICT01 are expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells) and are overexpressed on a number of solid tumors (e.g., bladder, colorectal, melanoma, ovarian pancreatic, lung) and hematologic cancers (e.g., leukemia & lymphoma). BTN3A appears essential for the activation of the anti-tumor immune response of γ9δ2 T cells.

ICT01 selectively activates circulating γ9δ2 T cells that leads to migration of γ9δ2 T cells out of the circulation and into target tissue (e.g., tumors or infection site), while also activating the tumor-resident γ9δ2 T cells. ICT01 has been shown to have anti-tumor activity against a range of cancers in in vitro and in vivo tumor models.

Mechanism of action

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, and the UK, with sites in the U.S. expected to start enrolling in early 2021.

Part 1 (dose escalation) of EVICTION 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 includes bladder, breast, colorectal, gastric, melanoma, ovarian, prostate, and pancreatic cancer, Group B includes AML, ALL, follicular lymphoma, and diffuse large B cell lymphoma, and Group C includes bladder, HNSCC, melanoma, and NSCLC. Basket trials represent a clinical trial design that allows new drugs to be tested rapidly in a range of indications, providing initial results on multiple parameters that can contribute to an accelerated development timeline.

Part 2 (cohort expansion) of EVICTION study will test the efficacy of ICT01 in target patient populations.

More information on the  EVICTION trial can be found at https://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

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

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

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

Paul Frohna MD, PhD, PharmD

Chief Medical Officer

ImCheck’s first clinical trial started in 2020

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.
We are now more than halfway through patient recruitment for dose escalation part of the trial and we remain on target to report on the topline results in 2021.