Ipsen to Acquire ImCheck Therapeutics to Advance Promising AML Immunotherapy ICT01

23 October 2025 | Thursday | News

The $350M upfront deal, with potential milestone payments up to €1B, targets first-line acute myeloid leukemia in unfit patients, leveraging encouraging Phase I/II EVICTION data showing high response rates and favorable tolerability.

  • Acquisition focused on lead clinical-stage program ICT01 in acute myeloid leukemia, where data from the ongoing Phase I/II EVICTION trial showed high treatment response
  • ICT01 has the potential to be a new standard of care in combination in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults
  • Ipsen to acquire all issued and outstanding shares of ImCheck Therapeutics, for which ImCheck Therapeutics’ shareholders will be eligible to receive a closing purchase price of 350 million euros and downstream payments contingent upon achievement of regulatory and sales-based milestones

Ipsen (Euronext: IPN; ADR: IPSEY) and ImCheck Therapeutics announced 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.

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 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.


 

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