Venetoclax

ImCheck to Present Encouraging Interim Results in AML Patients from the EVICTION Trial at the 66th American Society of Hematology Annual Meeting Marseille, France, November 26, 2024, 11 am CET – ImCheck Therapeutics announced today it will present positive interim results from its ongoing open-label, randomized Phase I/II study EVICTION at the 66th American Society of Hematology (ASH) Annual Meeting. The poster presentation will provide data on the novel γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in older and/or unfit patients. ICT01 is a first-in-class anti-butyrophilin 3A monoclonal antibody designed to activate γ9δ2 T cells among other immune cell classes. Data to be presented at ASH demonstrate that ICT01, both at the low and high dose levels, was safe and very well tolerated, and generated high rates of complete remission (CR) and composite CR across different molecular subgroups, particularly in TP53-mutated AML, a population with an especially poor prognosis (link to the abstract on the ASH 2024 website).Details of the poster presentation are: Abstract title: “The novel γ9δ2 T-cell activator ICT01 combined with azacitidine-venetoclax shows high rates of complete remission in older/unfit adults with newly diagnosed acute myeloid leukemia: interim results from Phase 1 study EVICTION” Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II Abstract number: 2876 Presenter: Abhishek Maiti, University of Texas MD Anderson Cancer Center Authors: Abhishek Maiti, Pierre Yves Dumas, Pierre Peterlin, Daniel Morillo, Jose Torregrosa, Paul B. Koller, Maelle Mairesse, Patrick Brune, Emmanuel Valenitn, Aude De Gassart, Katrien Lemmens, Daniel Olive, Naval Daver, Stephan Braun, and Sylvain Garciaz. Date: Sunday, Dec. 8, 2024 Time: 6:00-8:00 pm Location: Halls G-H (San Diego Convention Center) The ASH poster will be available on ImCheck’s corporate website after the poster sessions have been opened. ***About the EVICTION Study EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical study of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options. Part 1 (Phase I) is designed to characterize the preliminary safety, tolerability, and pharmacodynamic activity of increasing doses of ICT01 as monotherapy (Group A: solid tumors; Group B: hematologic tumors) and in combination with pembrolizumab (Group C: solid tumors). Group A includes urothelial cell, breast, colorectal, gastric, melanoma, ovarian, prostate, and pancreatic cancer patients, Group B includes acute myeloid leukemia, follicular lymphoma, and diffuse large B cell lymphoma patients. Group C includes urothelial cell, head-and-neck squamous cell carcinoma, melanoma, and non-small cell lung cancer patients. Part 2 is a Phase II cohort expansion study of monotherapy and combination treatment of patients with melanoma, urothelial cell, epithelial ovarian, prostate or head-and-neck squamous cell carcinoma, and acute myeloid leukemia. More information on the EVICTION study can be found at clinicaltrials.gov (NCT04243499). About ICT01ICT01 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 that is responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia & lymphoma) and also expressed on the surface of innate (e.g., 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 by data presented at past AACR, ASCO, ASH, ESMO and SITC conferences, ICT01 selectively activates circulating γ9δ2 T cells leading to migration of γ9δ2 T cells out of the circulation and into the tumor tissue activating tumor-resident γ9δ2 T cells and other immune effector cells with subsequent secretion of inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in vitro and in vivo as well as in patients across several indications. About IMCHECK THERAPEUTICS ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel super-family of immunomodulators. As demonstrated by its lead 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 produce superior clinical results as compared to the first-generation of immune checkpoint inhibitors and, when used in combination, to overcome resistance to this group of agents. In addition, ImCheck’s antagonist antibodies are being evaluated as potential treatments for a range of autoimmune and infectious diseases. ImCheck benefits from support from Prof. Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille University), a worldwide leader in γ9δ2 T cells and butyrophilins research, as well as from the experience of an expert management team and from the commitment of leading US and European investors. For further information: https://www.imchecktherapeutics.com/ Press contacts: US and EU Trophic CommunicationsGretchen Schweitzer +49 (0) 172 861 8540imcheck@trophic.eu FranceATCG PARTNERSCéline Voisin+33 (0)6 62 12 53 39imcheck@atcg-partners.com Attachment PR in English

First patients dosed in OV-AML-1231, a Phase 2 randomized controlled trial of cusatuzumab in newly diagnosed AML AURORA, CO, USA I November 21, 2024 I OncoVerity, a pioneer in applying advanced bioinformatics to drug development, announced today the closing of a Series A extension financing led by existing investors, argenx and RefinedScience. With this funding, OncoVerity aims to advance its mission to address the unmet medical need of cancer patients, leveraging a unique computational approach to inform a development strategy that seeks breadth and depth of response. The proceeds from the Series A extension will fund the Phase 2 OV-AML-1231 trial of cusatuzumab, a novel, first-in-class high-affinity monoclonal anti-CD70 antibody, in combination with venetoclax and azacitidine for the treatment of newly diagnosed acute myeloid leukemia (AML). The trial is enriched explicitly for patients with limited treatment options who show potential for responding to a cusatuzumab-based regimen, as informed by OncoVerity’s computational approach to guide its development. Patient enrollment is underway, and the first eight patients have been dosed. “This financing round is a critical step forward in accelerating the development of cusatuzumab,” said Max Colao, Chief Executive Officer at OncoVerity. “Cusatuzumab has the potential to treat a broad range of tumors, demonstrating a strong biologic rationale in AML. We are particularly excited about the potential of the Phase 2 trial, and look forward to sharing results from the interim analysis in the second half of 2025. These results will bring us closer to potentially offering a breakthrough new treatment option for AML patients. “This randomized phase 2 clinical trial was based on insights derived from machine learning-based approaches and will be analyzed using cutting-edge single cell omics technologies for depth and breadth of responses. This novel strategy was designed to optimize trial design and execution, address patient heterogeneity and other key patient specific needs and provide important insights into critical clinical and biologic areas. Together we hope this will help advance care for persons with AML and other cancers where there is urgent unmet medical need.” About OV-AML-1231 OV-AML-1231 is a randomized, open-label, multicenter, multinational, Phase 2 trial evaluating the safety and efficacy cusatuzumab combined with venetoclax, and azacitidine (VAC) to venetoclax and azacitidine (VA) in newly diagnosed AML patients not eligible for intensive chemotherapy. The planned enrollment is 120 newly diagnosed AML patients, randomized 2:1 to VAC (80 patients) and VA (40 patients). The trial population will be enriched for patients with adverse cytogenetic and molecular risk features. The primary end point is overall survival. Secondary endpoints include event-free survival, response rates including CR, CR+CRh, and rates of MRD negativity. About Cusatuzumab Cusatuzumab is a first-in-class high-affinity humanized monoclonal antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors, and severe autoimmune diseases. Cusatuzumab is designed to: block CD70, kill cancer cells expressing CD70 through complement-dependent cytotoxicity, enhance antibody-dependent cell-mediated phagocytosis, enhance antibody-dependent cell-mediated cytotoxicity, and restore immune surveillance against solid tumors (Silence K. et al. mAbs 2014; 6 (2):523-532) . Cusatuzumab is currently being evaluated in patients with hematologic malignancies, including a Phase 2 trial in combination with azacitidine and a Phase 1b trial in combination with azacitidine and venetoclax in patients with newly diagnosed AML. About Acute Myeloid Leukemia Acute myeloid leukemia (AML) is a cancer of the bone marrow and the blood that progresses rapidly without treatment. It is a heterogeneous disease with variable prognosis for different patient subpopulations. Despite the advancements in medical research, there is still a significant need for new effective therapies to treat AML. The five-year survival rate for patients remains the lowest of all blood malignancies (5-20%), and relapse is common. Innovative therapies and targeted treatment approaches that can improve survival rates, reduce toxicity, and target specific subtypes of AML are urgently needed to address this unmet need. About OncoVerity OncoVerity is pioneering the use of computational tools applied to clinical and biological data to advance therapies that transform hope into reality for cancer patients. Through a strategic collaboration with Refined Science , OncoVerity’s approach leverages an advanced bioinformatics platform that applies single-cell multi-omics and machine learning technologies to a large AML patient database to identify biologic drivers to therapeutic resistance and insights on patient-specific risk factors. This approach not only holds promise for accelerating the development of cusatuzumab in AML, but also has the potential to be applied to its development in other hematologic malignancies, signifying a broader impact on the future of cancer treatment by bringing new hope to a wider range of patients. SOURCE: OncoVerity