ICT01 / ImCheck Therap - LARVOL DELTA

ImCheck’s Announces EMA Orphan Drug Designation for ICT01 as Treatment for Acute Myeloid Leukemia (GlobeNewswire) - "ImCheck Therapeutics...announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, for the treatment of acute myeloid leukemia (AML). The designation in the EU follows the recently granted U.S. FDA ODD and provides additional validation of the therapeutic potential of ICT01 in AML, a disease with high unmet medical need and limited treatment options for older or unfit patients who are not eligible for intensive chemotherapy."

Orphan drug • Acute Myelogenous Leukemia

ImCheck’s ICT01 Receives FDA Orphan Drug Designation for Treatment of Acute Myeloid Leukemia (The Manila Times) - "ImCheck Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, for the treatment of acute myeloid leukemia (AML)."

Orphan drug • Acute Myelogenous Leukemia

γ9δ2 T-Cell Activation (γδTCA) With ICT01 and Azacitidine-Venetoclax (Aza-Ven) Induces High Rates of Complete Remission (CR) in Newly Diagnosed (ND) Acute Myeloid Leukemia (AML): Preliminary Results of the Phase 1/2 Study EVICTION (SOHO 2025) - P1/2 | "ICT01 was safe and well tolerated and generated very high CR and CR/CRi rates in older/unfit NDAML patients. The recommended phase 2 dose is 10 mg ICT01 Q4W with Aza-Ven. The high response rates seen in adverse-risk patients warrant further clinical investigation."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IFNG • KRAS • TNFA • TP53

γ9δ2 T-cell activation (γδTCA) with ICT01 combined with azacitidine-venetoclax (AV) for older/unfit adults with newly diagnosed (ND) AML: Preliminary efficacy and dose selection in phase 1/2 study EVICTION. (ASCO 2025) - P1/2 | "For AV combination, the recommended Phase 2 dose is 10 mg ICT01 Q4W. Both ICT01 regimens were safe and very well tolerated and generated very high CR and CR/CRi rates in older/unfit ND-AML pts. The high response rates seen in adverse risk pts warrant further clinical investigation."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Neutropenia • ASXL1 • DNMT3A • IDH1 • IDH2 • IFNG • JAK2 • NPM1 • NRAS • RUNX1 • SF3B1 • SRSF2 • STAG2 • TNFA • TP53 • U2AF1

EVICTION-2: Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=56 | Active, not recruiting | Sponsor: ImCheck Therapeutics | Trial primary completion date: Apr 2025 ➔ Sep 2025

Trial primary completion date • Colorectal Cancer • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Solid Tumor

ImCheck Reports High Remission Rates in AML Patients with ICT01 Combination Therapy at ASCO 2025 (GlobeNewswire) - P1/2 | N=292 | EVICTION (NCT04243499) | Sponsor: ImCheck Therapeutics | "39 patients were evaluable for efficacy. Clear signs of immune activation: ICT01 at the 10 mg dose provided optimal activation of γ9δ2 T cells and a downstream immune cascade, supporting its role in enhancing Aza-Ven efficacy, and confirming it as the proposed dose for further clinical development. Strong efficacy for ICT01 with Aza-Ven: Treatment with ICT01 at the proposed dose in combination with Aza-Ven resulted in high rates of CRc (96%) and CR (74%). Encouraging efficacy in difficult-to-treat AML patients: Among evaluable patients, the majority had adverse- or intermediate-risk genetic aberrations, which are typically associated with limited clinical benefit from Aza-Ven. Specifically, the CR and CRc rates in patients with TP53-mutated AML were 60% and 83%, respectively."

P1/2 data • Acute Myelogenous Leukemia

ICT01 Plus Azacitidine and Venetoclax Shows Early Evidence of Antitumor Activity in AML (OncLive) - P1/2 | N=292 | EVICTION (NCT04243499) | Sponsor: ImCheck Therapeutics | "Transient γ9δ2 T-cell (γ9δ2TC) activation with a low dose of ICT01 (ICT01low) plus azacitidine and venetoclax...augmented responses without sacrificing tolerability in patients with newly diagnosed...AML who were ineligible for standard intensive chemotherapy and hematopoietic stem cell transplant, according to data from the phase 1 EVICTION trial presented at the 2025 AACR Annual Meeting. Early onset and higher responses were seen with ICT01low-aza-ven compared with ICT01high-aza-ven. Within the ICT01low-aza-ven cohort (n = 23) the respective complete remission (CR) and CR, CR with partial hematological recovery, or CR with incomplete hematological recovery (CRc) rates were 39% and 52% in cycle 1, 57% and 83% in cycle 2, 70% and 90% in cycle 3, and 74% and 91% in cycle 4."

P1 data • Acute Myelogenous Leukemia

γ9δ2 T-cell (γδTC) activation and azacitidine-venetoclax (AV) for older/unfit adults with newly diagnosed (ND) acute myeloid leukemia (AML) induces high rates of complete remission (CR): Preliminary efficacy, safety, pharmacodynamics (PD) and dose selection of ICT01 in the phase 1 study EVICTION (AACR 2025) - "For AV combination, the recommended Phase 2 dose is 10 mg ICT01 Q4W. Both ICT01 regimens were safe and very well tolerated and generated very high CR and CR/CRi rates across molecular AML subtypes."

Clinical • P1 data • PK/PD data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • ASXL1 • IFNG • TNFA

ImCheck Announces Oral Presentation of Updated ICT01 Efficacy Data in First-line AML at the ASCO Annual Meeting 2025 (GlobeNewswire) - "ImCheck Therapeutics announced today an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2025....The presentation will focus on results from its ongoing open-label, randomized Phase I/II study EVICTION, including updated efficacy, safety and dose-selection data on the company’s lead γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of older or unfit patients with newly diagnosed acute myeloid leukemia (AML)."

P1/2 data • Acute Myelogenous Leukemia

EVICTION-2: Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=56 | Active, not recruiting | Sponsor: ImCheck Therapeutics | Recruiting ➔ Active, not recruiting | N=100 ➔ 56

Enrollment change • Enrollment closed • Colorectal Cancer • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Solid Tumor

EVICTION: First-in-Human Study of ICT01 in Patients with Advanced Cancer (clinicaltrials.gov) - P1/2 | N=292 | Active, not recruiting | Sponsor: ImCheck Therapeutics | Recruiting ➔ Active, not recruiting | N=150 ➔ 292 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Checkpoint inhibition • Enrollment change • Enrollment closed • Monotherapy • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bladder Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Gastric Cancer • Hematological Malignancies • Leukemia • Lymphoma • Melanoma • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

ImCheck to Present Updated ICT01 Data with Unprecedented High Rates of Complete Remission in AML at the AACR Annual Meeting 2025 (GlobeNewswire) - "ImCheck Therapeutics announced today it will present updated results from its ongoing open-label, randomized Phase I/II study EVICTION at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, Illinois, USA. The poster presentation will provide efficacy, safety, pharmacodynamics and dose selection data on the novel γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of patients with newly diagnosed AML."

P1/2 data • Acute Myelogenous Leukemia

ICT01, an Investigational γ9δ2 T Cell Activator, Added to Azacitidine-Venetoclax Achieves Frequent and Early Complete Remissions in Adults with AML Unfit for Intensive Induction Chemotherapy: Interim Results from the Ongoing Open-Label, Randomized Phase 1 Study Eviction (ASH 2024) - "Updated results with additional patients will be presented at the meeting. Conclusions In this ongoing Phase 1 study, both ICT01low‒AV and ICT01high‒AV were safe and very well tolerated and generated very high CR and CR/CRi rates in older/unfit patients newly diagnosed with AML."

Clinical • P1 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Immune Modulation • Immunology • Neutropenia • Oncology • Thrombocytopenia • ASXL1 • CD8 • GZMB

ICT01 and pembrolizumab in combination elicit deep and durable responses in heavily pretreated patients with urothelial cell carcinoma: interim results from study EVICTION (SITC 2024) - P1/2 | "Ethics Approval Study obtained ethics approval in all participating countries and at all sites for EU and US. Initial approvals: EC Jules Bordet, Belgium, 2020-01-23 CPP Sud Mediterranée V, Central Ethic Commitee, France 2020-02-03 Ethikkommission an der TU Dresden, Central Ethic Commitee, Germany 2020-04-15 CEC vall d'Hebron, Central Ethic Commitee, Spain 2020-02-12 Yale WIRB/Local, 26JAN2021 Seattle WIRB/Local, 02SEP2021 Moffit , Advarra, 23NOV2021 All amendments have been approved by same Ethics Comittees Participants gave informed consent before taking part."

Clinical • IO biomarker • Oncology • Urothelial Cancer • CD8

ICT01 and pembrolizumab in combination elicit deep and durable responses in heavily pretreated patients with refractory melanoma: interim results from study EVICTION (SITC 2024) - P1/2 | "Ethics Approval Study obtained ethics approval in all participating countries and at all sites for EU and US. Initial approvals: EC Jules Bordet, Belgium, 2020-01-23 CPP Sud Mediterranée V, Central Ethic Commitee, France 2020-02-03 Ethikkommission an der TU Dresden, Central Ethic Commitee, Germany 2020-04-15 CEC vall d'Hebron, Central Ethic Commitee, Spain 2020-02-12 All amendments have been approved by same Ethics Comittees Participants gave informed consent before taking parts."

Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • CD8 • IFNG • PD-L1

ImCheck to Present Encouraging Interim Results in AML Patients from the EVICTION Trial at the 66th American Society of Hematology Annual Meeting (GlobeNewswire) - "ImCheck Therapeutics announced today it will present positive interim results from its ongoing open-label, randomized Phase I/II study EVICTION at the 66th American Society of Hematology (ASH) Annual Meeting. The poster presentation will provide data on the novel γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in older and/or unfit patients."

P1/2 data • Acute Myelogenous Leukemia

ImCheck to Present Updated Data from the EVICTION Trial at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (GlobeNewswire) - "Both posters will provide updated results from the study assessing ICT01, a humanized anti-butyrophilin 3A (anti-BTN3A) monoclonal antibody that selectively activates γ9δ2 T cells, in combination with the checkpoint inhibitor pembrolizumab in patients with second-line or higher refractory metastatic melanoma and in patients with advanced urothelial cell carcinoma after failure with standard-of-care treatment."

P1/2 data • Melanoma • Urothelial Cancer

ImCheck Receives FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in First-Line Acute Myeloid Leukemia for Patients Unfit for Induction Chemotherapy Treatment (GlobeNewswire) - "ImCheck Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ICT01 in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML) patients 75 years or older, or who have comorbidities that preclude use of standard intensive induction chemotherapy. Based on encouraging results from the Phase 1 dose-escalation portion of the EVICTION study evaluating ICT01 monotherapy in relapsed/refractory hematological malignancies (European Society for Medical Oncology Congress 2023), ImCheck initiated in October 2023 a randomized dose-optimization cohort (NCT04243499), evaluating two doses of ICT01 in combination with azacitidine and venetoclax, the current standard of care for newly diagnosed patients with AML who are deemed unfit for induction chemotherapy."

Fast track • Acute Myelogenous Leukemia

ImCheck Awarded EUR 20.18 Million from the French Government Through the France 2030 Investment and Innovation Plan (GlobeNewswire) - "ImCheck Therapeutics announced today that it has received EUR 20.18 million in non-dilutive funding as part of the 'i-Démo' call for projects under the France 2030 Plan operated by Bpifrance on behalf of the French government. The funding will support the development of the company’s most advanced drug candidate, ICT01, a pathogen-agnostic γ9δ2 T cell-activating monoclonal antibody, currently in a Phase I/IIa clinical trial program in various solid cancer and hematologic malignancy indications."

Financing • Hematological Malignancies • Solid Tumor

EVICTION-2: Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: ImCheck Therapeutics | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Solid Tumor

EVICTION: First-in-Human Study of ICT01 in Patients With Advanced Cancer (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: ImCheck Therapeutics | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Mar 2024 ➔ Jun 2025

Checkpoint inhibition • Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bladder Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Gastric Cancer • Hematological Malignancies • Leukemia • Lymphoma • Melanoma • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

EVICTION study: ICT01, an anti-Butyrophilin 3A monoclonal antibody activating γ9δ2 T cells in combination with pembrolizumab in checkpoint inhibitor refractory melanoma. (ASCO 2024) - P1/2 | "ICT01 in combination with pembrolizumab has a favorable safety profile and promising efficacy data. Patient selection based on BTN3A tumor expression will be further evaluated as an enrichment strategy."

Checkpoint inhibition • Combination therapy • IO biomarker • Melanoma • Oncology • Solid Tumor • CD8 • IFNG • PD-1 • PD-L1

CD163 Targeted Peptide Screened by Phage Display as PET Tracer Imaging Resident Macrophages in Atherosclerosis (SNMMI 2024) - "This study demonstrated the successful development of a novel CD163 radiotracer binding to CD163+ macrophages by using phage display peptide screening. The elevated expression of CD163+ resident macrophages on human plaques indicated the potential of CD163 as a biomarker for vulnerable plaques. The sensitivity and specificity of 64Cu-ICT-01 imaging CD163+ macrophages warrant further investigation in translational settings."

Atherosclerosis • Cardiovascular • Dyslipidemia • APOE • CD163

Exploring Macrophage Dynamics in Myocardial Infarction Through CCR2 and CD163 PET Imaging (SNMMI 2024) - " [68Ga]-DOTA-ECL1i and [68Ga]-NODAGA-ICT-01 PET imaging were performed in a mouse model of ischemia-reperfusion injury-induced myocardial infarction... Our CCR2 and CD163 pair imaging demonstrated the dynamic variations of CCR2+ M1 and CD163+ M2 macrophages throughout the initiation, promotion, and resolution phases of inflammation. Tissue characterization robustly supports PET data on CCR2 and CD163 protein expression and immune cell profiles. Poster Award Candidate: Poster Award Candidate"

Cardiovascular • Myocardial Infarction • Oncology • Reperfusion Injury • CCR2 • CD163

ImCheck to Present Promising ICT01 Data from the EVICTION Study at ASCO 2024 (GlobeNewswire) - P1/2 | N=105 | EVICTION (NCT04243499) | Sponsor: ImCheck Therapeutics | "ICT01‒pembrolizumab combination treatment showed a clinically manageable safety profile with generally mild and clinically manageable first-dose Grade 1/2 infusion-related reactions (38%) and cytokine release syndrome (19%) as the most common adverse events across all doses and indications. In the CPI-refractory melanoma group, 21 patients were evaluable at week 16 with 3 partial responses and a disease control rate of 42%. In addition, biomarker analyses revealed clinical response was associated with baseline BTN3A tumoral expression, sustained elevation of IFNɣ levels, and tumor microenvironment remodeling."

P1/2 data • Melanoma • Oncology • Solid Tumor