First Patient Dosed in EVICTION Trial Evaluating ImCheck’s Lead Anti-Cancer Drug, ICT01: A Novel Gamma Delta T Cell-Activating Immunotherapy

March 26, 2020

— First-in-human, international, multi-center trial to test Butyrophylin 3A-targeted antibody in advanced solid and hematologic tumors —

Marseille, France, March 26, 2020 – ImCheck Therapeutics announced today that it has dosed the first patient in a Phase I/IIa clinical trial evaluating ICT01, a first-in-class gamma delta (gd) T cell-activatingmonoclonal antibody (mAb)targeting the extracellular domain of Butyrophilin 3A (BTN3A), a member of the butyrophilin superfamily of immuno-modulatory targets. EVICTION (EValuation of ICT01 in Immuno-ONcology) is a first-in-human, two-part, open-label clinical trial to assess the safety, tolerability and activity of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor in patients with advanced, relapsed/refractory cancer, including both solid and hematologic tumors that express BTN3A. The trial has been approved by regulators in France, Belgium, and Spain, with clinical trial applications pending or planned in the United Kingdom, Germany, and the United States.

“It is very exciting to lead the EVICTION trial that is testing ICT01 in patients with relapsed or refractory solid or hematologic malignancies. ICT01, with its unique mechanism of action, has the potential to be the next generation in immuno-oncology and provide a much needed option for cancer patients,”commented Aurélien Marabelle, MD, PhD, Clinical Director of the Cancer Immunotherapy Program at the Gustave Roussy Cancer Centre, Villejuif, France and Principal Investigator for EVICTION.

“Our entry into the clinic is a significant milestone for ImCheck and is the result of rigorous translational research needed for a first-in-human trial.  We would like to express our deep gratitude to the investigators and their teams for their incredible diligence and support during a very challenging  and difficult time with the COVID-19 pandemic,” said Paul Frohna, MD, PhD, Chief Medical Officer at ImCheck Therapeutics. “The results from our biomarker studies incorporated into this trial will begin to characterize the phenotypes and genotypes of responders/non-responders as part of our precision medicine-guided strategy for the ICT01 clinical development program.”

“The timeline from the discovery of the butryrophilin superfamily of targets to the development of a lead antibody candidate and entry into clinical evaluation is remarkable when you consider the groundbreaking potential of the science.  I applaud the ImCheck team for the focus and commitment needed for this achievement,” added Prof. Daniel Olive, MD, PhD, Professor of Immunology at Aix Marseille University Institut Paoli-Calmettes and Scientific Founder of ImCheck.