ImCheck to Present New Positive Data on ICT01 Monotherapy in Hematological Cancers at ESMO 2023
Interim data from Phase I dose escalation portion of EVICTION Phase I/IIa trial show strong safety profile and encouraging clinical activity for ICT01 monotherapy in relapsed/refractory hematological malignancies
ImCheck Therapeutics announced today that updated data from its ongoing Phase I/IIa clinical trial EVICTION will be presented at the European Society for Medical Oncology (ESMO) Congress in an oral session on October 22nd in Madrid. The presentation (822O) entitled: “Activation of γ9δ2 T Cells by ICT01 as a Novel Immunotherapeutic Approach for Relapsed/Refractory Hematologic Cancers (EVICTION Study)” will provide safety and patient response results from the Phase I dose escalation portion of the EVICTION trial of ImCheck’s lead antibody, ICT01, administered as a monotherapy to relapsed/refractory patients with hematological cancers, primarily Acute Myeloid Leukemia (AML).
“The positive safety profile, consistent with previous data in solid tumor patients, together with the promising clinical activity underscores the potential of ICT01 in hematological malignancies. These results in last-line patientsfurther support the initiation of the ongoing Phase IIa cohort expansion study of ICT01 in combination with standard of care in first-line AML patients,” commented Sylvain Garciaz, M.D., Ph.D., member of the Department of Hematology, Institut Paoli-Calmettes, investigator in the EVICTION study, and presenter of the data at ESMO 2023.
“We continue to generate highly encouraging clinical signals in both solid and hematological tumors. We remain focused on rapidly advancing ICT01 into late-stage clinical evaluation in combination settings as a unique clinical approach to boost the anti-tumor immune response in cancer patients,” commented Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics.
EVICTION is an open-label Phase I/IIa trial assessing ICT01, a humanized anti-BTN3A monoclonal antibody that selectively activates γ9δ2 T cells, as a monotherapy in solid and hematological tumors, and as a combination therapy with pembrolizumab in solid tumors. The Phase 1 dose escalation study in relapsed/refractory hematological cancers included 26 patients who failed all available standard of care, 24 of which had acute myeloid leukemia, 1 with diffuse large B-cell lymphoma and 1 with follicular lymphoma. ICT01 was administered at doses ranging from 200 μg to 75 mg every 21 days and primary endpoints consisted of the incidence of treatment-adverse events (AE) and the disease control rate (DCR) defined as the sum of complete response (CR), CR with incomplete recovery (CRi), partial response (PR) and stable disease (SD). Secondary endpoints included circulating γ9δ2 T cell measurements as well as pharmacokinetic and pharmacodynamic analyses. The reported data did not reveal any dose-limiting toxicities and demonstrated a DCR of 30% among the 10 evaluable patients at week 8. Notably, ICT01 treatment safely induced the activation and migration of γ9δ2 T cells from the blood within hours of dosing, suggesting effective target engagement.
Based on these results, the company has started evaluating ICT01 in combination with Venetoclax/azacitidine in a Phase IIa expansion cohort in first-line AML patients.