French biopharmaceutical company Ipsen announced on October 22, 2025, its acquisition of ImCheck Therapeutics for up to €1 billion, marking a significant expansion of its oncology pipeline with a novel immunotherapy for acute myeloid leukemia (AML). The transaction centers on ICT01, a first-in-class monoclonal antibody that has demonstrated encouraging clinical results in patients with newly diagnosed AML who are ineligible for intensive chemotherapy.
Promising Clinical Data Drives Strategic Acquisition
The acquisition is primarily motivated by interim data from the ongoing Phase I/II EVICTION trial, which enrolled 45 patients and showed that ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. According to data presented at the American Society of Clinical Oncology 2025, treatment response nearly doubled relative to those seen in historical standard of care data across all molecular subtypes in newly diagnosed patients, including sub-types typically less responsive to standard of care.
"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," said David Loew, CEO of Ipsen. The combination therapy was also shown to be well tolerated, underscoring ICT01's potential as a novel immunotherapy to improve outcomes for patients with AML.
Novel Mechanism Targeting Unmet Medical Need
ICT01 represents a breakthrough in immunotherapy design, functioning as a humanized anti-BTN3A monoclonal antibody that promotes the recognition and elimination of tumor cells by γδ T cells. The drug targets BTN3A (also known as CD277), a key immune-regulatory molecule broadly expressed across cancer. By altering the conformation of BTN3A, ICT01 promotes binding that selectively activates circulating γδ T cells, leading to their migration from circulation into tumor tissue and triggering a downstream immunological cascade through secretion of pro-inflammatory cytokines, including IFNγ and TNFα.
The therapy addresses a critical unmet medical need in AML treatment. Many AML patients are unable to tolerate intensive chemotherapy and must rely on lower-intensity options, which often deliver limited and short-lived benefit. This high-risk, unfit population continues to face a significant unmet medical need, highlighting the urgency for new therapies that can improve survival and quality of life.
Regulatory Recognition and Development Timeline
ICT01 received Orphan Drug Designations from both the U.S. Food and Drug Administration and European Medicines Agency in July 2025, recognizing its potential to address rare disease populations. The EVICTION trial is a first-in-human, dose-escalation and cohort-expansion clinical trial evaluating ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers, as well as newly-diagnosed AML.
"Joining Ipsen will help us accelerate ICT01 toward registrational studies and commercialization," said Pierre d'Epenoux, CEO of ImCheck Therapeutics. The company's approach builds on pioneering research from Prof. Daniel Olive at Institut Paoli Calmettes, INSERM, CNRS, and Aix-Marseille University, a global leader in γδ T cells and butyrophilins.
Transaction Structure and Financial Terms
Under the definitive share purchase agreement, ImCheck Therapeutics shareholders will receive €350 million on a cash-free and debt-free basis at closing, with additional deferred payments contingent upon achieving specified regulatory approvals and sales-based milestones. The total potential consideration reaches up to €1 billion.
The transaction is expected to close by the end of Q1 2026, subject to customary closing conditions including regulatory and governmental approvals under French and U.S. regulations. Allen & Overy Shearman serves as legal counsel to Ipsen, while Centerview Partners acts as exclusive financial advisor to ImCheck Therapeutics.
Broader Therapeutic Potential
Beyond AML, ICT01's mechanism of action shows promise across multiple cancer types. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors, including melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer, as well as hematologic malignancies such as leukemia and lymphomas. Anti-tumor activity and efficacy of ICT01 have been demonstrated in patients across several cancer indications.
ImCheck Therapeutics' pipeline extends beyond oncology, with compounds progressing toward clinical development for autoimmune and infectious diseases. The company's first-in-class activating antibodies may deliver superior clinical outcomes compared to first-generation immunotherapy approaches, particularly in rational combinations with immune checkpoint inhibitors and immunomodulatory anti-cancer drugs.
