Clinical Data with ImCheck’s ICT01 to be Presented at AACR: Positive Results Observed on Safety, Activation of Gamma 9 Delta 2 T Cells and Anti-tumor Immune Response

|   Science & Medicine

  • ICT01 activates γ9δ2 T cells that rapidly migrate out of the circulation and secrete IFNγ and TNFα leading to an expanded immune system activation

  • Increased densities of activated and proliferating γδ, CD3+ and CD8+ T cells were observed in tumor biopsies post ICT01 treatment

Marseille, France, April 9, 2021 – ImCheck Therapeutics announced today that data from its ongoing EVICTION Phase I/IIa clinical trial will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2021 in an oral presentation (CT034) by Aurélien Marabelle, MD, PhD, Lead Investigator for EVICTION, titled: “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”, on April 11, 2021 from 4:50 – 5:00 PM US ET in the CTMS03 - Clinical Trials with Novel Immuno-oncology Strategies session.

ICT01 is a first-in-class, anti-BTN3A monoclonal antibody that activates γ9δ2 T cells, a subset of tumor infiltrating lymphocytes that have potent cytotoxic effects on solid and hematologic cancer cells and can activate other immune cells against the cancer. To the company’s knowledge, the data that will be presented is the first demonstration of an activating antibody safely and dose-dependently engaging γ9δ2 T cells that also coordinate an anti-tumor immune response from the innate and adaptive immune systems.

The ongoing EVICTION trial is evaluating ICT01 in patients with advanced, relapsed/refractory solid and hematologic cancers with no remaining standard of care. The abstract published today covers results from four cohorts of patients with solid tumors (n=20) and one cohort of patients with hematologic cancer (n=3) and demonstrated that ICT01 monotherapy, at doses from 20 µg to 20 mg, achieved safe and potent activation of the anti-tumor immune responses of γ9δ2 T cells.

Across the cohorts treated, more than 95% of γ9δ2 T cells migrated out of the circulation at all four ICT01 doses. Levels of IFNγ and TNFα increased in a generally dose-dependent manner, which correlated with baseline γ9δ2 T cell counts, and activation and migration of NK and CD8+ T cells from the circulation at doses ≥7 mg. The second ICT01 administration induced similar cell activation and trafficking. Immunhistochemical staining showed a significant increase in γδ, CD3 and CD8  T cells in several tumor biopsies post ICT01 treatment, indicating that ICT01, via tumor-infiltrating activated γ9δ2 T cells, induces a broad anti-tumor immune response within the tumor microenvironment.

“These new data from increasing doses of ICT01 indicate that ICT01 safely and dose-dependently activates γ9δ2 T cells that induce an expanded immune system activation within the blood and tumor, which supports our proposed mechanism of action,” commented Aurélien Marabelle, MD, PhD, Immuno-Oncologist at Gustave Roussy, Villejuif, France and Lead Investigator for EVICTION, who will present the data at the AACR. “We look forward to completing Part 1 and initiating Part 2 where we will test the efficacy of ICT01 in target patient populations.”

“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 Part 1 of the trial and we remain on target to report on the topline results in 2021,” said Paul Frohna, MD, PhD, Chief Medical Officer at ImCheck Therapeutics. “We are thankful for the efforts of the EVICTION investigators and their study teams, and their patients’ willingness to participate in our trial despite the ongoing pandemic.”

Following multiple safety reviews by the independent Safety Review Committee, the EVICTION trial has continued to dose escalation in all arms of the study.

The AACR presentation slides will be available starting April 11, 2021 at 5:00 pm US Eastern Time / 23:00 CET on ImCheck’s corporate website.