• ICT01 in combination with azacitidine and venetoclax (Aza-Ven) achieves unprecedented high remission rates overall andacross molecular subtypes in newly diagnosed AML patients

• Favorable safety profile, with Grade ≥3 adverse events consistent with expected Aza-Ven hematological toxicity and AML-related effects

• ICT01 10 mg is the proposed dose for further clinical development

• Oral presentation at ASCO 2025: Monday, June 2, 2025, 5:12 p.m.- 5:24 p.m. CDT, Room S100a

Marseille, France, May 22, 2025, 5:00 pm ET/11:00 pm CET – ImCheck Therapeutics today announced the publication of its abstract for an upcoming oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The presentation will feature updated data from the ongoing Phase I/II EVICTION study. The study evaluates ICT01, a novel γ9δ2 T-cell activator, administered in combination with azacitidine and venetoclax (Aza-Ven) in patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. The updated interim results demonstrate a 96% composite complete remission (CRc) rate, including 74% complete remissions (CR), with responses observed across molecular subtypes. Notably, high response rates were achieved in patients with adverse- or intermediate-risk mutations, a population typically less responsive to Aza-Ven. In addition, the preliminary 9-month overall survival rate for patients treated with 10 mg of ICT01 was 83%, underscoring the strong clinical potential of the novel triple combination. The oral presentation will be held 5:12 p.m.- 5:24 p.m. CDT, on Monday, June 2, during Session “Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant” (Room S100a).

“The updated data reinforce ICT01’s potential to meaningfully enhance the therapeutic effects of Aza-Ven in AML by harnessing the unique biology of γ9δ2 T cells,” said Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics. “The depth and consistency of responses observed with ICT01, combined with its manageable safety profile, provide a strong foundation as we advance toward a randomized study.”

Key Highlights:

• Patient population: At the data cut-off on January 20, 2025, 45 patients aged 51 to 87 were enrolled. A total of 29 patients received 10 mg of ICT01 and 16 patients received 75 mg of ICT01, each in combination with Aza-Ven; of these, 39 patients were evaluable for efficacy.
• Clear signs of immune activation: ICT01 at the 10 mg dose provided optimal activation of γ9δ2 T cells and a downstream immune cascade, supporting its role in enhancing Aza-Ven efficacy, and confirming it as the proposed dose for further clinical development.
• Strong efficacy for ICT01 with Aza-Ven: Treatment with ICT01 at the proposed dose in combination with Aza-Ven resulted in high rates of CRc (96%) and CR (74%).
• Encouraging efficacy in difficult-to-treat AML patients: Among evaluable patients, the majority had adverse- or intermediate-risk genetic aberrations, which are typically associated with limited clinical benefit from Aza-Ven. Specifically, the CR and CRc rates in patients with TP53-mutated AML were 60% and 83%, respectively.
• Early survival trends: At a median follow-up time of 8.5 months, high response rates were associated with a longer duration of response and an improved 9-month overall survival. While these time-to-event data are encouraging, they remain preliminary because the majority of patients are still on treatment.
• Favorable safety profile: The combination treatment was clinically well manageable, with a low 30-day mortality rate of 4% (all deaths unrelated to ICT01) and a low rate of infectious complications. The most frequent adverse events of Grade ≥3 were febrile neutropenia, neutropenia, thrombocytopenia, and sepsis, reported as unrelated to ICT01 and consistent with the known hematological toxicity of Aza-Ven.

“Patients with newly diagnosed AML, particularly those with high-risk genetic features, continue to face limited therapeutic options. Our results suggest that ICT01’s ability to engage γ9δ2 T cells could offer a powerful new option for a population typically underserved by current therapies,” added Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics.“Based on this compelling validation of our novel approach and the momentum we are building as an organization, we will accelerate clinical development of ICT01 in patients with AML, myelodysplastic syndrome, and select solid tumor indications. We are grateful for the patients’ participation in our study and the support from the investigators, the ImCheck team and our investors.”