Presents Positive Safety and Efficacy Data from Completed Phase 1 Dose Escalation Cohort… | Your money

Broad antitumor immune responses and demonstration of durable disease control in patients with solid tumors who had previously failed one or more checkpoint inhibitor regimens, over a range of doses of ICT01 in combination with pembrolizumabICT01 demonstrated a favorable and consistent safety and tolerability profile without dose-limiting toxicities in combination, in line with the results of monotherapy

ImCheck Therapeutics today presented promising safety and patient response data from the full dose-escalation combination cohort of its ongoing EVICTION clinical trial during an oral session at the European Society of Medical Oncology (ESMO) which is currently being held in Paris, France. EVICTION is an open-label phase I/IIa study evaluating ImCheck’s lead antibody ICT01 as monotherapy in solid tumors and hematological cancers, and in combination with pembrolizumab in solid tumors.

Results from the combined Phase I dose-escalation cohorts (n=40 across 6 dose levels) demonstrated that treatment with ICT01 plus pembrolizumab induced disease control in 42% of melanomas (5/12), 22 % of non-small cell lungs (4/18), 22% of patients with bladder cancer (2/9), and in 1 patient with head and neck squamous cell carcinoma (HNSCC), (1/1) according to RECIST1.1 criteria. All treated patients had previously failed at least one checkpoint inhibitor (CPI) regimen, highlighting the potential of ICT01 combination therapy as a new option for relapsed/refractory patients after CPI treatment. , which remains a significant unmet medical need. Two partial responses were achieved in melanoma patients who achieved follow-up beyond 6 and 16 months, with the latter patient also achieving durable complete regression of a brain metastasis from 6 months. General antitumor response data suggest that higher baseline circulating γ9δ2 T cell levels are correlated with better treatment outcomes. This supports the planned patient enrichment strategy using a lower baseline γ9δ2 T cell count, compared to ICT01 monotherapy, for eligibility in the upcoming phase IIa combination groups of patients with IPC-refractory melanoma , chemotherapy-resistant bladder cancer, or IPC-refractory HNSCC.

“The data presented today demonstrate that the complementary mechanisms of action of ICT01 and pembrolizuma alter the tumor microenvironment to generate clinical responses against multiple IPC-resistant solid tumors,” commented Paul Frohna, MD, PhD, Medical Director at ImCheck Therapeutics. “It is encouraging to see a continued good safety profile for ICT01 under the combination in addition to the robust activation of γ9δ2T cells that promote tumor infiltration of CD8 and NK cells, which can be fully released to attack tumors. cancer cells by concomitant blockade of PD-1.”

Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics, added: “With these positive data, we further confirm the potential of ICT01 as an innovative and differentiated therapeutic approach for a large population of cancer patients. . We are confident that we have achieved our goals for the first part of the EVICTION trial, both in monotherapy the expansion is already underway and in combination with pembrolizumab.

The oral presentation, titled “The combination of ICT01, a γ9δ2 T-cell activating mAb, plus pembrolizumab induces a broad antitumor immune response and disease control in patients with CPI-failure melanoma, NSCLC, and prostate cancer. bladder: EVICTION trial”, was given by Dr Stéphane Champiat, principal investigator of the EVICTION study at the Gustave Roussy Cancer Center, Paris, France. The data was presented during the Experimental Immunotherapy session from 2:45 p.m. to 4:15 p.m. CEST on Saturday, September 10, 2022.

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About the EVICTION Trial EVICTION is a first-in-man, dose-escalating (Part 1) and cohort-expanding (Part 2) clinical trial of ICT01 in patients with various advanced solid or hematologic cancers, relapsed or refractory, who have exhausted standard treatment options. Part 1 is a collaborative trial designed to characterize the preliminary safety, tolerability and pharmacodynamic activity of ICT01 as monotherapy (group A: solid tumors; group B: hematological tumors) and in combination with pembrolizumab (group C: solid tumors). Group A includes patients with bladder, breast, colorectal, gastric, melanoma, ovary, prostate and pancreatic cancer, Group B includes acute myeloid leukemia, acute lymphoid leukemia, follicular lymphoma and patients with diffuse large B-cell lymphoma, and group C includes bladder, patients with head and neck squamous cell carcinoma, 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 endpoints that can contribute to an accelerated development timeline. Part 2 of the trial is a Phase II cohort expansion study in selected indications, both as monotherapy and in combination. The first indications selected for the Phase II monotherapy expansion cohorts are relapsed/refractory ovarian cancer and metastatic castration-resistant prostate cancer. For more information about the EVICTION trial, visit clinicaltrials.gov (NCT04243499). A second clinical trial, EVICTION-2, evaluating the combination of ICT01 and low-dose subcutaneous IL-2 to selectively increase the number of γ9δ2 T cells in patients with solid tumors (prostate cancer, pancreas, ovary or colorectal) is also in progress ( NCT05307874).

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 immunosurveillance of malignancies and infections. The 3 isoforms of BTN3A targeted by ICT01 are overexpressed on a number of solid tumors (eg bladder, colorectal, melanoma, ovary, pancreatic, lung) and hematological cancers (eg leukemia & lymphoma) and also expressed on the surface of the innate (eg, γδ 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 EVICTION data presented at recent AACR, EMSO, and SITC conferences, ICT01 selectively activates circulating γ9δ2 T cells, resulting in migration of γ9δ2 T cells out of circulation and into target tissues (e.g., tumors ), while also activating the tumor. resident γ9δ2 T cells to directly kill malignant cells, which is accompanied by the secretion of two key inflammatory cytokines, IFNγ and TNFα, 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 leading clinical-stage program ICT01, which has a mechanism of action to simultaneously modulate innate and adaptive immunity, ImCheck’s “first-in-class” activating antibodies may be able to deliver results clinical superiority over first-generation immune checkpoint inhibitor antibodies and, when used in combination, to overcome resistance to this group of agents. Additionally, ImCheck’s 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 Pr Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille University), world leader in research on γ9δ2 T lymphocytes and butyrophilins; the experience of an expert management team; and the commitment of leading US and European investors.

For more information: https://www.imchecktherapeutics.com/ and @ImCheckThx

Press contacts

Trophic Communications US and EU Gretchen Schweitzer +49 (0) 172 861 8540 imcheck@trophic.eu

France ATCG PARTNERS Céline Voisin +33 (0)9 81 87 46 72 / +33 (0)6 62 12 53 39 imcheck@atcg-partners.com

Attachments

PR in EnglishPresentation to ESMO