IPN60340 / ImCheck Therap, Ipsen - LARVOL DELTA

ICT01-AZACITIDINE-VENETOCLAX INDUCES HIGH REMISSION RATE IN PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA: RESULTS FROM THE PHASE 1/2 STUDY EVICTION (EBMT 2026) - P1/2 | "ICT01 was safe, well tolerated, and associated with high CR and CRc rates in older/unfit ND-AML patients. The high response rate and promising early OS signal, warrant further clinical investigation. Consistent PD effects suggest an individual contribution of ICT01 to the efficacy of the novel triplet regimen ICT01-Aza-Ven."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Malignancies • Leukemia • Neutropenia • CD8 • IFNG

ICT01-AZACITIDINE-VENETOCLAX INDUCES HIGH REMISSION RATE IN PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA: RESULTS FROM THE PHASE 1/2 STUDY EVICTION (EBMT 2026) - P1/2 | "ICT01 was safe, well tolerated, and associated with high CR and CRc rates in older/unfit ND-AML patients. The high response rate and promising early OS signal, warrant further clinical investigation. Consistent PD effects suggest an individual contribution of ICT01 to the efficacy of the novel triplet regimen ICT01-Aza-Ven."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Malignancies • Leukemia • Neutropenia • CD8 • IFNG

γ9δ2 T-cell (γ9δ2TC) activation with ICT01 and azacitidine-venetoclax (Aza-Ven) induces high rates of remission and overall survival in patients with newly diagnosed (ND) acute myeloid leukemia (AML): Results from the phase 1/2 study eviction (ASH 2025) - P1/2 | "ICT01 was safe, well tolerated and generated very high CR and CRc rates in older/unfitpatients with ND-AML. Both the high response rate and the promising early OS signal which comparefavorably to recently published studies warrant further clinical investigation. Consistent PD effectssuggest an individual contribution of ICT01 to the efficacy of the novel triplet regimen ICT01-Aza-Ven."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Neutropenia • CD8 • IFNG • TNFA

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: First-in-Human Study of ICT01 in Patients With Advanced Cancer (clinicaltrials.gov) - P1/2 | N=292 | Active, not recruiting | Sponsor: ImCheck Therapeutics | Trial primary completion date: Oct 2026 ➔ Oct 2025

Checkpoint inhibition • First-in-human • 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

The combination of ICT01, a γ9δ2 T cell-activating mAb, plus pembrolizumab induces a broad antitumor immune response and disease control in patients with CPI-failure melanoma, NSCLC and bladder cancer: EVICTION trial (ESMO 2022) - P1/2 | "The 3 melanoma responders were IPI/Nivo refractory, with 2 PRs achieved at 2 & 20 mg in pts with high baseline γ9δ2 T cell counts. Conclusions ICT01 plus pembro is a novel immunotherapeutic approach worth further study in CPI failure pts."

Clinical • IO biomarker • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD8 • CXCL10 • IFNG • IL1B • PD-1 • TNFA

ICT01, an anti-butyrophilin 3A targeted mAb activating g9d2 T cells, induces immune remodeling of the tumor microenvironment and clinical responses in combination with pembrolizumab in patients with advanced solid tumors who failed prior checkpoint inhibitor therapy: EVICTION Trial (AACR 2022) - P1/2 | "The immune remodeling of the TME by ICT01-activated γ9δ2 T cells is associated with clinical benefit in CPI-experienced patients when used in combination with pembrolizumab. The selection of patients with higher baseline γ9δ2 T cells may improve the response profile to this novel therapeutic combination in CPI-failure patients, which will be tested in the Phase 2a portion of EVICTION starting in Q2 2022."

Biomarker • Checkpoint inhibition • Clinical • Combination therapy • IO biomarker • Tumor microenvironment • Bladder Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • CD8 • IFNG • PD-1 • TNFA

U.S. FDA grants Ipsen’s IPN60340 (ICT01) Breakthrough Therapy Designation in first line unfit Acute Myeloid Leukemia (Ipsen Press Release) - "This Breakthrough Therapy Designation is based on data from the Phase I/II EVICTION trial....we look forward to discussing the design of the Phase II/III development plans with the FDA for IPN60340 in H1 2026."

Breakthrough therapy • Clinical protocol • New P2/3 trial • 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 | Completed | Sponsor: ImCheck Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Colorectal Cancer • 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 | Trial completion date: Dec 2025 ➔ Oct 2026 | Trial primary completion date: Sep 2025 ➔ Oct 2026

Checkpoint inhibition • First-in-human • 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

ImCheck Reports Durable Responses and Early Overall Survival Signal with ICT01 in First-line AML at ASH 2025 (GlobeNewswire) - "ImCheck Therapeutics today announced updated results from its Phase I/II EVICTION study....Patient population: At the data cut-off on October 6, 2025, 57 patients aged 51 to 87 had been enrolled....Rapid responses: More than 90% of patients treated with ICT01 (10 mg) achieved CRc4 as their best response already by end of Cycle 2....Durability emerging: At a median follow-up of 10.8 months median DoR5 was not yet reached for the 10 mg ICT01 dose. Early survival signal: A 12-month OS6 rate of 62% was observed, which is numerically higher than the ~54% reported for the Aza-Ven regimen in recent Phase 3 trials."

P1/2 data • Acute Myelogenous Leukemia

ImCheck Announces Oral Presentation of ICT01 First-Line AML Data at the 67th ASH Annual Meeting (GlobeNewswire) - "The presentation will highlight the high remission rates and overall survival observed in EVICTION, ImCheck’s open-label, randomized Phase I/II study evaluating ICT01, a first-in-class γ9δ2 T-cell activator, in combination with azacitidine and venetoclax in older or unfit patients with newly diagnosed acute myeloid leukemia (AML)."

P1/2 data • Acute Myelogenous Leukemia

Evaluation of ICT01, a γ9δ2 T Cell-Activating Monoclonal Antibody, Combined with Venetoclax and Azacitidine in 1L AML (EVICTION Study) (ASH 2023) - P1/2 | "ICT01, a first-in-class anti-BTN3A mAb activating γ9δ2 T cells, completed Phase 1 testing in relapsed/refractory (r/r) solid tumors as monotherapy and in combination with pembrolizumab, and as monotherapy in r/r AML and lymphoma (EVICTION-NCT04243499). Encouraging results obtained in the EVICTION Phase 1 trial and preclinical demonstration of the benefit of using ICT01 plus VEN/AZA allowed the initiation of a Phase 2a expansion cohort to evaluate the clinical benefit of this combination in 1L AML patients."

Acute Myelogenous Leukemia • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • CD8 • CXCL8 • IFNG • IL10 • IL17A • IL2 • IL4 • IL6 • TNFA

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, a γ9δ2 T-cell-activating mAb, in combination with pembrolizumab elicits deep and durable responses in second-line patients with primary refractory melanoma: results from EVICTION study (SITC 2025) - P1/2 | "The modeled dose of 10 mg ICT01 Q3W is proposed for future studies investigating the clinical potential of ICT01-pembrolizumab.Trial Registration ClinicalTrials.gov ID: NCT04243499 EudraCT Number: 2019-003847-31Ethics Approval All patients gave informed consent before taking part in the study. The study obtained ethics approval from all institutions involved including Vall hebron (Spain), N°412 Universite Dresden (Germany) AMG MONO-EK-5012020, Institut Jules Bordet (Belgium): CE3083, IRAS ID 282711 (UK), CPP Sud mediterrannée V N°2019-003847-31 et N° CNRIPH 19.10.30.51143 (France) and all IRBs of US institutions involved."

Clinical • Combination therapy • Late-breaking abstract • Melanoma • Oncology • Solid Tumor • CD8 • IFNG • PD-1

Ipsen to acquire ImCheck Therapeutics, expanding its leadership in oncology, strengthening its pipeline (Ipsen Press Release) - "The anticipated acquisition is focused on the lead Phase I/II program ICT01 in first line acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy...'We feel confident that with the ICT01 promising data combined with Ipsen’s global development and commercialization expertise, we are well positioned to start a Phase IIb/III trial in 2026.'....The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions including the expiration or termination of any required regulatory and governmental approvals under French and U.S. regulations."

M&A • New P2/3 trial • 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

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

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