ImCheck Therapeutics has recently announced that it will present updated results from its Phase I/II EVICTION study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation will focus on ICT01, a humanized anti-BTN3A monoclonal antibody that activates γ9δ2 T cells, when used in combination with pembrolizumab in patients suffering from refractory melanoma.
The EVICTION study aims to validate ICT01 as a novel therapeutic option and to inform its future clinical development. Pierre d’Epenoux, CEO of ImCheck Therapeutics, highlighted the potential of the ICT01-pembrolizumab combination, especially in patients whose melanoma has proven resistant to checkpoint inhibitors.
The data to be presented at ASCO includes comprehensive safety data from all patient cohorts, as well as preliminary efficacy data from ongoing evaluations conducted every eight weeks in patients with metastatic melanoma. The combination treatment of ICT01 and pembrolizumab has demonstrated a manageable safety profile. The most common adverse events were mild first-dose infusion-related reactions (38%) and cytokine release syndrome (19%).
In the CPI-refractory melanoma cohort, 21 patients were evaluated at the 16-week mark. Among these patients, there were three partial responses and a disease control rate of 42%. Biomarker analyses revealed that patients who responded to the treatment had baseline BTN3A expression in their tumors, elevated levels of IFNɣ, and significant changes in the tumor microenvironment. These findings will guide further studies to use biomarker-driven patient selection as a strategy to enhance treatment efficacy.
The poster presentation at ASCO will include detailed findings, and it will be available on ImCheck’s corporate website after the event.
About the EVICTION Study:
EVICTION is a first-in-human clinical study involving dose escalation and cohort expansion stages. It investigates ICT01 in patients with advanced, relapsed, or refractory solid and hematologic cancers who have exhausted standard treatment options. This study is divided into three groups:
- Group A: Solid tumors including bladder, breast, colorectal, gastric, melanoma, ovarian, prostate, and pancreatic cancer.
- Group B: Hematologic tumors such as acute myeloid leukemia, acute lymphocytic leukemia, follicular lymphoma, and diffuse large B cell lymphoma.
- Group C: Solid tumors including bladder, head and neck squamous cell carcinoma, melanoma, and non-small cell lung cancer, in combination with pembrolizumab.
The study uses a basket trial design to rapidly test ICT01 across various indications, providing crucial data that can speed up its development. The Phase II cohort expansion phase will explore ICT01 as both a monotherapy and in combination with other treatments, initially focusing on ovarian cancer and metastatic castrate-resistant prostate cancer.
Additionally, another clinical study, EVICTION-2, is examining ICT01 combined with low-dose subcutaneous IL-2 to selectively expand γ9δ2 T cells in patients with specific solid tumors, including prostate, pancreatic, ovarian, and colorectal cancers.
About ICT01:
ICT01 is a monoclonal antibody targeting BTN3A, essential for activating γ9δ2 T cells which play a role in immune surveillance of malignancies and infections. BTN3A is overexpressed in various solid and hematologic cancers and is also found on innate and adaptive immune cells. ICT01 activates γ9δ2 T cells to migrate to tumors and eradicate malignant cells, promoting a robust anti-tumor immune response.
About ImCheck Therapeutics:
ImCheck Therapeutics develops innovative immunotherapeutic antibodies targeting butyrophilins. Their lead program, ICT01, modulates both innate and adaptive immunity, potentially offering superior clinical results compared to first-generation immune checkpoint inhibitors. ImCheck's antagonist antibodies are also being explored for treating autoimmune and infectious diseases. The company benefits from the expertise of Prof. Daniel Olive and a seasoned management team, supported by leading investors in the US and Europe.
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