FDA Grants Fast Track to ImCheck's ICT01 Combo for Untreatable AML

ImCheck Receives FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax for First-Line Acute Myeloid Leukemia in Patients Unfit for Induction Chemotherapy Treatment

ICT01, an innovative humanized antibody targeting butyrophilin 3A, is engineered to selectively activate Vγ9Vδ2 T cells. Recent clinical data from the ongoing Phase 1/2a EVICTION study has shown promising results in acute myeloid leukemia (AML).

Marseille, France, September 18, 2024 – ImCheck Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ICT01. This designation is for its use in combination with azacitidine and venetoclax for treating AML patients aged 75 or older, or those with health conditions that make standard intensive induction chemotherapy unfeasible.

Encouraging outcomes from the Phase 1 dose-escalation segment of the EVICTION study, which examined ICT01 monotherapy in patients with relapsed or refractory hematologic cancers, led to further research. This data, presented at the European Society for Medical Oncology Congress 2023, prompted ImCheck to initiate a randomized dose-optimization cohort in October 2023. This cohort is assessing two doses of ICT01 combined with azacitidine and venetoclax, the current treatment standard for newly diagnosed AML patients unsuitable for induction chemotherapy.

Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics, commented on the development: “The growing body of data on ICT01, together with the FDA’s Fast Track designation, further validates our efforts in developing ICT01 for first-line AML patients. This underscores the urgent need for therapies that achieve higher response rates and improve overall survival for these patients. We are optimistic about ICT01’s potential in both solid tumors and hematological cancers and anticipate sharing updates from the EVICTION study at upcoming scientific meetings.”

The FDA’s Fast Track status aims to facilitate the development and quicken the review process of drugs that have the potential to address serious conditions and unmet medical needs. A candidate with Fast Track designation may engage in more frequent interactions with the FDA to discuss the development plan and might be eligible for Priority Review and Accelerated Approval based on clinical data, thereby potentially bringing approved therapies to patients sooner.

The EVICTION trial is an open-label multicohort Phase 1/2a study exploring ICT01, a humanized antibody that selectively activates γ9δ2 T cells. The study includes cohorts testing ICT01 both as a monotherapy and in combination therapies for solid and hematological tumors. In the Phase 1 dose-escalation cohort, presented at ESMO 2023, 26 patients with relapsed or refractory hematological cancers were included. Among them, 24 had AML, one had diffuse large B-cell lymphoma, and another had follicular lymphoma. No dose-limiting toxicities were observed for ICT01 at doses ranging from 200 μg to 75 mg administered every 21 days. Encouraged by the safety and pharmacokinetic data, a dose-optimizing and efficacy-estimating phase was initiated for newly diagnosed AML patients who are older or deemed unfit for standard chemotherapy, with 29 patients enrolled so far.

Emerging data on the pharmacodynamics and pharmacokinetics of ICT01 in combination with azacitidine and venetoclax indicated consistent activation and migration of γ9δ2 T cells from the blood within hours of dosing. This suggests effective target engagement, which correlates with observed efficacy.

About IMCHECK THERAPEUTICS

ImCheck Therapeutics is developing a new wave of immunotherapeutic antibodies targeting butyrophilins, a novel super-family of immunomodulators. Their lead program, ICT01, aims to modulate both innate and adaptive immunity through its "first-in-class" activating antibodies, potentially offering superior clinical outcomes compared to current immune checkpoint inhibitors and overcoming resistance when used in combination. Additionally, their antagonist antibodies are being explored for treating various autoimmune and infectious diseases.

ImCheck benefits from the expertise of Prof. Daniel Olive, a global authority in γ9δ2 T cells and butyrophilins research, and from the experience of an adept management team and committed investors from the US and Europe.