ImCheck Achieves the Primary Objectives of Phase I of the EVICTION-2 Trial of ICT01 in Combination with Low Dose IL-2, Data Presented at AACR 2023

|   Science & Medicine

  • ICT01 in combination with low dose IL-2 safely induced substantial γ9δ2 T cell expansion across multiple dosing cycles for all dose cohorts of patients with advanced solid tumors

  • Activation of expanded innate and adaptive antitumor immune responses also observed across all dose cohorts                              

ImCheck Therapeutics announced today data from its ongoing Phase I/IIa clinical trial EVICTION-2 at the American Association for Cancer Research (AACR) Annual Meeting 2023 in a poster presentation (CT179) titled: “First-in-Human Study of ICT01, an Anti-BTN3A Activating Monoclonal Antibody in Combination with Low Dose IL-2 in Patients with Advanced Solid Tumors (EVICTION-2 Study)”.  As described in the poster, ImCheck’s lead antibody ICT01, administered at doses ranging from 1 to 75 mg, combined with low-dose subcutaneous IL-2 (1 MIU/m2) safely induced multi-cycle expansion of γ9δ2 T cells in 11/11 evaluable patients with no dose limiting toxicities and no new safety events observed. The combination also generated innate and adaptive immune stimulation characterized by the activation, mobilization, and expansion of CD8 T cells, NKs and granulocytes. Taken together, these data demonstrate achievement of the primary objectives of Phase I of the study, support that this combination could be a novel approach to maximize γ9δ2 T cell-mediated antitumor efficacy, and set the foundation for the Phase IIa portion of EVICTION-2.

In addition to a good safety profile and broad immune expansion and stimulation, we observed an increase in PD-1 and PD-L1 expression on various immune cell populations, suggesting checkpoint inhibitor therapy may significantly enhance clinical response to this combination.  We plan to test this in Phase IIa of EVICTION-2 by adding pembrolizumab to the combination regimen,” commented Paul Frohna, MD, PhD, Chief Medical Officer at ImCheck Therapeutics.

Details of the poster presentation are:

  • Abstract title: “First-in-Human Study of ICT01, an Anti-BTN3A Activating Monoclonal Antibody in Combination with Low Dose IL-2 in Patients with Advanced Solid Tumors (EVICTION-2 Study)”
  • Session title: First-in-Human Phase I Clinical Trials 2
  • Abstract number: CT179
  • Authors: Johann de Bono, Stéphane Champiat, Francois-Xavier Danlos, Martin Wermke, Volker Kunzmann, Aude De Gassart, Emmanuel Valentin, Marina Iché, Maelle Mairesse, Patrick Brune, Katrien Lemmens, Aurélien Marabelle, Daniel Olive, Paul Frohna
  • Date/Time: Tuesday Apr 18, 2023, 9:00 AM - 12:30 PM Eastern Time
  • Location: Poster Section 45
  • Poster Board Number: 11

The AACR poster will be available starting April 18, 2021, at 12:30 pm US Eastern Time / 18:30 CEST on ImCheck’s corporate website.