On October 22, 2025 Ipsen (Euronext: IPN; ADR: IPSEY) and ImCheck Therapeutics reported they have entered into a definitive share purchase agreement in which Ipsen will acquire all issued and outstanding shares of ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The anticipated acquisition is focused on the lead Phase I/II program ICT01 in first line acute myeloid leukemia (AML)3 patients who are ineligible for intensive chemotherapy. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.
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Many AML patients are unable to tolerate intensive chemotherapy and must rely on lower-intensity options, which often deliver limited and short-lived benefit.2 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.
"At completion, the acquisition of ImCheck Therapeutics presents an opportunity for us to expand our pipeline in oncology and reinforces our commitment to deliver transformative therapies to the people who need them most," said David Loew, CEO, Ipsen. "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."
Interim data (n=45) orally presented at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 20251 from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, 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 (Ven-Aza).2 ICT01 in combination with Ven-Aza was also shown to be well tolerated, underscoring ICT01’s potential as a novel immunotherapy to improve outcomes for patients with AML.
"We are thrilled to become part of Ipsen, a company whose ambition for transformative care matches our commitment to bringing innovative treatments to patients. This transaction recognizes groundbreaking science originating from French academia," said Pierre d’Epenoux, CEO, ImCheck Therapeutics. "It also highlights the exceptional work the ImCheck team and our partners have achieved to advance the understanding of butyrophilns and gamma delta T cells. Joining Ipsen will help us accelerate ICT01 toward registrational studies and commercialization. I remain grateful to the patients and investors for their contributions to furthering ImCheck’s pioneering science."
Transaction details
Under the terms of the agreement, through a wholly owned affiliate of Ipsen SAS, shareholders of ImCheck Therapeutics will receive a 350 million euros payment on a cash-free and debt-free basis at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones, for a total potential consideration up to 1 billion euros.
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.
Advisors
Allen & Overy Shearman (Paris) is acting as legal counsel to Ipsen. Centerview Partners is acting as exclusive financial advisor to ImCheck Therapeutics with Goodwin (London) and Dentons (Paris) acting as legal counsel.
About the EVICTION trial
EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).
About ICT01
ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that promotes the recognition and elimination of tumor cells by γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and are also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). Binding to BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. By altering the conformation of BTN3A, ICT01 promotes this binding, thereby selectively activating circulating γ9δ2 T cells. This leads to migration of γ9δ2 T cells out of the circulation and into the tumor tissue, and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in patients across several cancer indications.
(Press release, Ipsen, OCT 22, 2025, View Source [SID1234656868])