ImCheck Achieves Initial Positive Independent Safety Review and Initiates Next Stage of Phase I/IIa EVICTION Trial for ICT01. Company Receives FDA Approval for US IND

September 10, 2020

ImCheck Therapeutics announced today that the independent Safety Review Committee for the EVICTION  Phase I/II clinical trial for its lead antibody ICT01 (NCT04243499) unanimously approved dose escalation in the solid tumor indications and the start of enrollment in the two other arms of the study: treatment with ICT01 in patients with hematologic malignancies as monotherapy and in solid tumor patients in combination with pembrolizumab. The first patients in the second cohort have now been treated.

ImCheck’s Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) cleared in August of this year, allowing for U.S. patient inclusion in EVICTION. The first U.S. sites will include the MD Anderson Cancer Center, Yale University Cancer Center and the University of Washington/Seattle Cancer Care Alliance.

“ICT01 is a first-in-class activating antibody designed to target cancer cells directly through cytotoxic activity and indirectly through the activation of other immune cells. Approval from the independent safety review committee is therefore an important achievement, enabling us to move ahead with the second phase of the study and remain on track with our planned timeline,” said Paul Frohna, MD, PhD, Chief Medical Officer at ImCheck Therapeutics. “We are excited to expand the trial to include patients with hematologic cancers and to test ICT01 in combination with pembrolizumab. Our focus is now on achieving our patient enrollment goals, confirming pharmacodynamic activity and demonstrating clinical proof of mechanism.”

EVICTION is an open-label basket study assessing the safety, tolerability and activity of ICT01 as monotherapy in patients with advanced solid or hematologic malignancies, and in combination with pembrolizumab in patients with solid tumors. The first cohort enrolled six patients treated at four different starting doses of ICT01 as monotherapy, followed by intra-patient dose-escalation. No dose-limiting toxicities or related serious adverse events were reported. ICT01 is a gamma9 delta2 (γ9δ2) T cell-activatingmonoclonal antibody (mAb)targeting Butyrophilin 3A (BTN3A), a member of the butyrophilin superfamily of immunomodulators.

“ICT01 is the first of a series of novel agents targeting butyrophilins that we are developing at ImCheck. The outstanding ground work in early development coupled with strong relationships with the clinical centers has enabled us to move rapidly through the first stage of the Phase I study, treat the first patients in the second cohort and open the IND in the U.S.,” said Pierre d’Epenoux, Chief Executive Officer at ImCheck Therapeutics. “All of us at ImCheck thank the patients, investigators and the sites for continuing to support EVICTION during these difficult times due to the COVID-19 crisis.”

Full press release can be found here.