ImCheck Announces Oral Presentation of ICT01 First-Line AML Data at the 67th ASH Annual Meeting
MWN-AI** Summary
ImCheck Therapeutics has announced an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting 2025, focusing on the promising data from their Phase I/II study named EVICTION. This study evaluates ICT01, a groundbreaking investigational therapy designed to activate ?9?2 T-cells, in combination with azacitidine and venetoclax for older or unfit patients diagnosed with acute myeloid leukemia (AML). The presentation will take place on December 7, 2025, at the Orlando Convention Center, highlighting the significant remission rates and overall survival outcomes achieved in the study. Dr. Sylvain Graciaz from the Institut Paoli-Calmettes will conduct the presentation.
The EVICTION study is a first-in-human trial that investigates ICT01’s safety and efficacy, assessing its potential in treating various advanced cancers, including hematologic malignancies like AML. The study comprises two parts: the first focuses on safety and tolerability, while the second aims to optimize dosages and estimate effectiveness for different cancer types through expanded cohorts.
ICT01 is a monoclonal antibody that selectively activates ?9?2 T-cells, crucial for enhancing the immune response against tumors and infections. It targets BTN3A, a protein overexpressed in various cancers, offering a unique and promising approach to treatment.
ImCheck’s innovative platform aims to transform cancer treatment through its novel immunotherapeutic antibodies that modulate both innate and adaptive immunity. The company is advancing its clinical programs and recently agreed to be acquired by Ipsen, highlighting its promising pipeline and the increasing interest in its unique treatment strategies. The upcoming presentation at ASH is expected to draw significant attention from the medical and investment communities alike.
MWN-AI** Analysis
ImCheck Therapeutics recently announced the oral presentation of promising data for ICT01 at the upcoming American Society of Hematology (ASH) Annual Meeting 2025. The emphasis on high remission rates and overall survival in older or unfit patients with newly diagnosed acute myeloid leukemia (AML) presents substantial potential for the company, especially given the limitations of current treatment options in this patient demographic. Investors should watch this presentation closely, as its outcomes could significantly impact ImCheck's stock trajectory.
The EVICTION study showcases ICT01’s unique approach as a first-in-class ?9?2 T-cell activator, particularly when combined with azacitidine and venetoclax. These combination therapies align with the current trend in oncology where multi-drug regimens have been yielding improved patient outcomes. Should the presentation validate these results, it could spotlight ICT01 as a breakthrough therapy in AML, attracting both analyst attention and increased investor interest.
The strategic timing of this announcement comes as ImCheck prepares for a planned acquisition by Ipsen, anticipated to close by Q1 2026. This merger could enhance resources and capabilities for ImCheck, particularly in expediting clinical development. Furthermore, the integration could extend the reach of ICT01 across more malignancies, leveraging Ipsen’s established market presence.
In conclusion, investors should consider the upcoming ASH presentation a pivotal moment for ImCheck. A positive outcome could catalyze a rally in stock prices, while diminished results might induce cautious trading. Balancing these factors is crucial, but today’s environment appears primed for innovative therapies that showcase robust clinical efficiency, particularly within oncology. Monitoring ImCheck before and after the ASH conference will be essential for both current and prospective investors.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
ImCheck Announces Oral Presentation of ICT01 First-Line AML Data at the 67th ASH Annual Meeting
Marseille, France, December 5, 2025 05:00 a.m. ET / 11:00 a.m. CET– ImCheck Therapeutics announced today an oral presentation at the upcoming American Society of Hematology (ASH) Annual Meeting 2025 , taking place from December 6 to December 9, in Orlando, FL, USA . 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 ?9?2 T-cell activator, in combination with azacitidine and venetoclax in older or unfit patients with newly diagnosed acute myeloid leukemia (AML).
Details of the oral presentation at ASH 2025 are:
- Abstract Title: “?9?2 T-cell (?9?2TC) 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”
- Presenter: Sylvain GRACIAZ, MD, PhD, Institut Paoli-Calmettes, Marseille, France
- Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Immunotherapy and chemotherapy combinations in AML
- Room : OCCC - Chapin Theater (320)
- Date: Sunday, December 7, 2025
- Time: 5:15 p.m.- 5:30 p.m. ET
The ASH presentation will be available on ImCheck’s corporate website after the presentation has been held.
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About the EVICTION Study
EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical study of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options. Part 1 (Phase I) is designed to characterize the preliminary safety, tolerability, and pharmacodynamic activity of increasing doses of ICT01 as monotherapy (Group A: solid tumors; Group B: hematologic tumors) and in combination with pembrolizumab (Group C: solid tumors). Part 2 comprises randomized dose-optimizing and efficacy estimating expansion cohorts of monotherapy (Group D: ovarian cancer; Group E: prostate cancer) and combination treatment of patients with AML (Group F), melanoma (Group G), urothelial cell carcinoma (Group H), or head-and-neck squamous cell carcinoma (Group I). More information on the EVICTION study can be found at clinicaltrials.gov (NCT04243499).
About ICT01
ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates ?9?2 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 also expressed on the surface of innate (e.g., ?? T cells and NK cells) and adaptive immune cells (T cells and B cells). BTN3A is essential for the activation of the anti-tumor immune response of ?9?2 T cells.
As demonstrated by data presented at past AACR, ASCO, ASH, ESMO and SITC conferences, ICT01 selectively activates circulating ?9?2 T cells leading to migration of ?9?2 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 IFN? and TNF?, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in patients across several cancer indications.
About IMCHECK THERAPEUTICS
ImCheck Therapeutics is developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel superfamily of immunomodulators. By unlocking the power of ?9?2 T cells, ImCheck’s innovative approach has the potential to transform treatments across oncology, autoimmune, and infectious diseases.
The lead clinical-stage program, ICT01, has been advancing to late-stage trials, demonstrating a unique mechanism of action that modulates both innate and adaptive immunity. These “first-in-class” activating antibodies may deliver superior clinical outcomes compared to first-generation immunotherapy approaches, in particular in rationale combinations with immune checkpoint inhibitors and immunomodulatory anti-cancer drugs. Additionally, ImCheck’s pipeline compounds are progressing toward clinical development for autoimmune and infectious diseases.
The company benefits from the pioneering research of Prof. Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille University), a global leader in ?9?2 T cells and butyrophilins, as well as the expertise of a seasoned management team and the commitment of leading U.S. and European investors. As announced on October 22, Ipsen (Euronext: IPN; ADR: IPSEY) and ImCheck have entered into a definitive share purchase agreement in which Ipsen will acquire all issued and outstanding shares of ImCheck, with the transaction close anticipated by the end of Q1 2026.
For further information: https://www.imchecktherapeutics.com/
Press contacts:
US and EU
Trophic Communications
Gretchen Schweitzer
+49 (0) 172 861 8540
imcheck@trophic.eu
France
ATCG PARTNERS
Céline Voisin
+33 (0)6 62 12 53 39
imcheck@atcg-partners.com
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FAQ**
How might the upcoming oral presentation at ASH 2025 impact investor sentiment towards ImCheck Therapeutics and its potential relationship with Ipsen ADR IPSEY?
What are the specific high remission rates and overall survival statistics for ICT01 in the EVICTION study, and how could these results affect the investment prospects for ImCheck Therapeutics and Ipsen ADR IPSEY?
In what ways does ICT01's mechanism of action differ from traditional immunotherapies, and how could this influence the strategic partnership with Ipsen ADR IPSEY in the oncology market?
What are the anticipated regulatory milestones for ICT01 following the ASH presentation, and how might these developments influence the valuation of ImCheck Therapeutics and its acquisition by Ipsen ADR IPSEY?
**MWN-AI FAQ is based on asking OpenAI questions about Ipsen ADR (OTC: IPSEY).
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