ImCheck Provides Up-To-Date and Promising Patient Response Data From Phase I / IIa Eviction Trial With ICT01 At SITC 2021 Meeting | Antibody


ImCheck Provides Up-To-Date and Promising Patient Response Data from Phase I / IIa Eviction Trial with ICT01 at SITC 2021

  • The oral presentation includes positive safety data over a wide range of doses of ICT01 and efficacy data from patients receiving ICT01 plus pembrolizumab confirming durable clinical responses to low doses of ICT01
  • Patient with checkpoint inhibitor-refractory metastatic melanoma achieved complete brain metastasis response and partial liver metastasis response at six months
  • The company will present a collaboration poster with Neoleukin on the preclinical combination of ICT01 plus NL201, a novel IL-2 / IL-15 agonist, which safely induces activation, proliferation and anti- activity. γ tumor9δ2 T cells

MARSEILLE, France November 1 12, 2021 I ImCheck Therapeutics provided updated data on patient response from its ongoing EVICTION Phase I / IIa clinical trial of its lead candidate ICT01 in an oral presentation at the 2021 meeting of the Society for Immunotherapy of Cancer ( SITC). with the combination of low dose ICT01 and pembrolizumab which had previously failed at least one previous checkpoint inhibitor treatment, 62% showed disease control according to RECIST1.1 criteria. Two patients presented a preliminary positive durable response at 24 and 32 weeks. In a metastatic melanoma patient with brain metastasis, who would generally not respond to standard treatments, a complete brain metastasis response was observed at week 27 of treatment. ImCheck presents these updates in addition to two posters covering ICT01 at SITC. The conference takes place in Washington, DC and virtually, November 10-14, 2021.

“These latest data from the EVICTION trial support our confidence that ICT01 has significant potential to provide significant therapeutic effects, particularly in patients with advanced metastatic solid tumors who have not responded to previous checkpoint inhibitor therapy,” commented Paul Frohna, MD, PhD, medical director at ImCheck Therapeutics. “Even if the response to brain metastases needs to be replicated in more patients, provides a Very valuable clinical development opportunity in a group of patients with high unmet medical need that we intend to explore further.

In today’s oral presentation, titled Clinical activity of ICT01, an anti-BTN3A-activating γ9δ2 mAb, alone and in combination with pembrolizumab in patients with advanced / refractory solid tumors: EVICTION trial“, Teacher. Martin Wermke, Early Clinical Trials Unit, Carl Gustav Carus University Hospital, Dresden, Germany, presented results demonstrating anti-tumor responses induced by ICT01 plus pembrolizumab in patients with various solid tumors. Five of eight patients (bladder cancer, metastatic melanoma, non-small cell lung cancer (n = 3)) achieved disease control at 8 weeks and beyond according to RECIST1.1, including two partial responses to week 16 and beyond.

In the poster presentation titled “ICT01, an anti-BTN3A monoclonal antibody, and NL-201, an alpha-independent IL-2 / IL-15 agonist, combine to elicit a potent anti-tumor response by stimulating synergistically activating Vγ9Vδ2 T cells and proliferation ”, a preclinical study of ICT01 plus NL-201 treatment suggests favorable results for the synergistic activity of the two candidates through enhanced activation, expansion and anti-tumor activity of γ9δ2 T cells compared to monotherapy. The synergistic effect of this combined treatment argues in favor of a more in-depth study of this therapeutic approach.

The second poster, “Correlation of Baseline Circulating 9δ2 T Cells Counts and Pharmacodynamic Activity of ICT01 in Cancer Patients: Preliminary Results from EVICTION and a Novel Patient Enrichment Strategy,” assessed the relationship between the baseline number of circulating 9δ2 T cells in patients and their response to ICT01 as an enrichment strategy that is being implemented in the monotherapy extension arms of the EVICTION trial.

rock d’Epenoux, CEO of ImCheck Therapeutics added: “These new clinical data and the preclinical combination data provide a better understanding of ICT01 and allow us to extend our pipeline strategy in one product to additional indications and combinations. We are building momentum in the EVICTION trial, including the start of recruitment in the phase 2a portion of the study with monotherapy in patients with squamous cell carcinoma of the ovary or of the head and neck using the base number of ??9δ2 T lymphocytes as an enrichment strategy for patients as described in our second SITC poster.

All posters displayed in the Poster Room will be available as virtual posters throughout the 36th SITC Annual Meeting.

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About the foreclosure trial
EVICTION is an unprecedented dose escalation (part 1) and cohort extension (part 2) human clinical trial of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers who have exhausted standard treatment options. Part 1 is a basket trial designed to characterize the safety, tolerability and preliminary pharmacodynamic activity of ICT01 as monotherapy (Group A: solid tumors; Group B: hematologic tumors) and in combination with pembrolizumab (Group C : solid tumors). Group A includes patients with bladder, breast, colorectal, gastric, melanoma, ovarian, prostate and pancreatic cancer, group B includes acute myeloid leukemia, acute lymphoid leukemia, follicular lymphoma and diffuse large B-cell lymphoma, and group C includes bladder, squamous cell carcinoma of the head and neck, melanoma, and non-small cell lung cancer. Basket trials are a clinical trial design that allows rapid testing of new drugs in a range of indications, providing initial data on multiple parameters that can contribute to an accelerated development timeline. More information about the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

About ICT01
ICT01 is a humanized anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates γ9δ2 T cells, which are part of the innate immune system responsible for the immunosurveillance of malignancies and infections. The 3 BTN3A isoforms targeted by ICT01 are overexpressed in a number of solid tumors (eg, bladder, colorectal, melanoma, ovary, pancreas, lung) and hematologic cancers (eg, leukemia and lymphoma) and also expressed in surface of 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 γ9δ2 T cells.

As demonstrated in the EVICTION data presented to the AACR, ICT01 selectively activates circulating 9δ2 T cells that cause γ9δ2 T cells to migrate out of the circulation and into target tissue (eg, tumors), while activating also the tumor-resident γ9δ2 T cells to directly kill the malignant cells, which is accompanied by the secretion of two key inflammatory cytokines, IFNg and TNFa, which contribute to the expansion of the anti-tumor immune response . ICT01 has been shown to have anti-tumor activity against a range of cancers in in vitro and in vivo tumor models.

About IMCHECK THERAPEUTICS

ImCheck Therapeutics designs and develops a new generation of immunotherapeutic antibodies targeting butyrophilins, a new superfamily of immunomodulators.

As demonstrated by the ICT01 clinical stage program, which has a mechanism of action to simultaneously modulate innate and adaptive immunity, ImCheck’s “first-in-class” activator antibodies may be able to produce clinical results. superior to the first generation of immune checkpoint inhibitors and, when used in combination, to overcome resistance to this group of agents. In addition, ImCheck antagonist antibodies are being evaluated as potential treatments for a range of autoimmune diseases.

Co-founder of the Marseille Immunopole cluster, ImCheck benefits from the support of Prof. Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille University), world leader in research on γδ T lymphocytes and butyrophilins; the experience of an expert management team; and the commitment of major American and European investors.

For more information on ImCheck: http://www.imchecktherapeutics.com and @ImCheckThx

THE SOURCE: ImCheck Therapeutics


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