IPN60340 / ImCheck Therap, Ipsen - LARVOL DELTA

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

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

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

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

PET Imaging of Tumor-Associated Macrophage Dynamics and Response to Clinical Treatment for Potential Translation. (PubMed, J Nucl Med) - " 64Cu-ICT-01 demonstrated accurate targeting of CD163 in both mouse tumor models and human HNSCC tissues. CD163 PET has great potential to be a noninvasive biomarker to measure TAM activities within TME, monitor treatment response, and optimize treatment strategy."

Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD163

EVICTION: First-in-Human Study of ICT01 in Patients With Advanced Cancer (clinicaltrials.gov) - P1/2 | N=293 | Active, not recruiting | Sponsor: ImCheck Therapeutics, an Ipsen company | Trial primary completion date: Oct 2026 ➔ Oct 2027

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

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 | Terminated | Sponsor: ImCheck Therapeutics, an Ipsen company | Completed ➔ Terminated; The study was terminated based on sponsor decision unrelated to safety or efficacy. The study met the key primary and secondary endpoints, however two patients were receiving treatment at the decision point, preventing protocol-defined completion.

Trial termination • Colorectal Cancer • Melanoma • 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=293 | Active, not recruiting | Sponsor: ImCheck Therapeutics, an Ipsen company | Trial completion date: Oct 2026 ➔ Oct 2027 | Trial primary completion date: Oct 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

EVICTION 3: A Study to Assess How Well the Study Medicine IPN60340 Works in Combination With Azacitidine and Venetoclax, Compared to Placebo in Combination With Azacitidine and Venetoclax, in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Cannot Receive Intensive Chemotherapy (clinicaltrials.gov) - P2/3 | N=450 | Not yet recruiting | Sponsor: Ipsen

New P2/3 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Kinetic modelling and radiomics analysis of the heterogeneity of tumor-associated macrophages and metabolism in head and neck cancer (SNMMI 2026) - "[64Cu]Cu-ICT-01 showed tissue differentiation and greater textural info and may be able to better identify malignant tumors that will progress in severity (Fig. 1C). [18F]FDG provides good quantitative differentiation but is unable to differentiate tissues within a tumor well."

Heterogeneity • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD163

Kinetic modelling and radiomics analysis of the heterogeneity of tumor-associated macrophages and metabolism in head and neck cancer (SNMMI 2026) - "[64Cu]Cu-ICT-01 showed tissue differentiation and greater textural info and may be able to better identify malignant tumors that will progress in severity (Fig. 1C). [18F]FDG provides good quantitative differentiation but is unable to differentiate tissues within a tumor well."

Heterogeneity • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD163

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

ICT01/IPN60340-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/IPN60340 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/IPN60340 to the efficacy of the novel triplet regimen ICT01/IPN60340-Aza-Ven."

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

ICT01/IPN60340-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/IPN60340 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/IPN60340 to the efficacy of the novel triplet regimen ICT01/IPN60340-Aza-Ven."

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

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

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