BTN3A1

ImCheck Announces Oral Presentation of Updated ICT01 Efficacy Data in First-line AML at the ASCO Annual Meeting 2025 April 23, 2025 – ImCheck Therapeutics announced today an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2025, taking place from May 30 to June 3, in Chicago, Illinois, USA. The presentation will focus on results from its ongoing open-label, randomized Phase I/II study EVICTION, including updated efficacy, safety and dose-selection data on the company’s lead γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of older or unfit patients with newly diagnosed acute myeloid leukemia (AML). Details of the oral presentation at ASCO 2025 are: Abstract Title: “γ9δ2 T-cell activation with ICT01 combined with azacitidine-venetoclax for older/unfit adults with newly diagnosed AML: Preliminary efficacy and dose selection in phase 1/2 study EVICTION” Session: Oral Abstract Session S100a - Hematologic Malignancies - Leukemia, Myelodysplastic Syndromes, and Allotransplant Date: Monday, June 2, 2025 Time: 5:12 p.m.- 5:24 p.m. Central Time 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). Part 2 comprises randomized dose-optimizing and efficacy estimating expansion cohorts of monotherapy (Group D: ovarian cancer; Group E: prostate cancer) and combination treatment of patients with AML (Group F), melanoma (Group G), urothelial cell carcinoma (Group H), or head-and-neck squamous cell carcinoma (Group I). ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates γ9δ2 T cells, which are 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 and lymphomas) 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 and triggers a downstream immunological cascade through secretion of pro-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 patients across several cancer indications. ImCheck Therapeutics is developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel superfamily of immunomodulators. By unlocking the power of γ9δ2 T cells, ImCheck’s innovative approach has the potential to transform treatments across oncology, autoimmune, and infectious diseases. The lead clinical-stage program, ICT01, has been advancing to late-stage trials, demonstrating a unique mechanism of action that modulates both innate and adaptive immunity. These “first-in-class” activating antibodies may deliver superior clinical outcomes compared to first-generation immunotherapy approaches, in particular in rationale combinations with immune checkpoint inhibitors and immunomodulatory anti-cancer drugs. Additionally, ImCheck’s pipeline compounds are progressing toward clinical development for autoimmune and infectious diseases. The company benefits from the pioneering research of Prof. Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille University), a global leader in γ9δ2 T cells and butyrophilins, as well as the expertise of a seasoned management team and the commitment of leading U.S. and European investors. The content above comes from the network. if any infringement, please contact us to modify.

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

23 September 2024 Roquefort Therapeutics plc ("Roquefort Therapeutics" or the "Company") Grant of Japan MK Cell Patent Roquefort Therapeutics (LSE:ROQ), the Main Market listed biotech company focused on developing first in class medicines in the high value and high growth immunology and oncology markets, is pleased to announce that the Japan Patent Office has granted the patent for its Mesodermal Killer ("MK") cell therapy. The granting of the MK cell patent by the Japan Patent Office follows the granting of the European patent announced on 2 September 2024, thereby expanding patent protection to the UK, EU and Japan. Novel Cellular Immunology / Oncology Medicine Mesodermal Killer cells are a novel therapeutic cell type developed from the pioneering work of Roquefort Therapeutics' non-executive director, Nobel Laureate, Professor Sir Martin Evans. MK cells display a novel immunophenotype[i] and thus represent a new class of cell, which is confirmed by the granting of patents by the European Patent Office and the Japan Patent Office. The MK cells form an off-the-shelf (allogenic) cellular immunotherapy, with both a direct effect and the ability to recruit and activate Natural Killer ("NK") cells[ii] to modulate an immune response in immunology and oncology indications. Commercial Opportunity in Japan There is a two-fold commercial significance to the granting of the MK cell patent in Japan. Firstly, the Japan patent enables the opportunity to licence the MK cells to Japan Big Pharma companies for the Japan market alone, where the Roquefort Therapeutics' Board has extensive experience of working and partnering (including with Big Pharma companies such as Daiichi Sankyo, Astellas and Chughai). Secondly, the granted Japan patent allows the Company to access an accelerated route-to-market for promising cellular medicines in Japan. The accelerated designation not only speeds up drug development, but also the market approval (MAA) assessment. The attractive benefit package that this designation confers includes market approval granted based on Phase 1 and 2 clinical trials if safety is confirmed[iii]. This may significantly increase the value of cellular medicines as this enables a cheaper and faster route to market. Pre-Clinical Development Since Roquefort Therapeutics acquired the MK cell program as part of the Oncogeni acquisition in 2022, the Company has tested the MK cells in combination with NK cells. MK cells were shown to activate Natural Killer cells and this activation produced up to a two-fold increase in NK efficacy, indicating the potential for MK + NK combination medicines in the high value difficult to treat immunology and oncology disease areas. The Company now plans to complete in vivo studies in preparation for a key value inflection point of initiating a clinical study. This clinical trial may utilise the favourable clinical trial and tax regimes in Japan and Australia to enable faster and cheaper routes to market. Roquefort Therapeutics CEO Ajan Reginald commented: "The granting of this Japan patent for MK cell therapy highlights both the quality of our intellectual property and the novelty of the MK cells together with the enhanced commercial opportunity in Japan. The granted patent creates the opportunity for the Company to out-license the MK cell rights for the territory of Japan to a Japanese Big Pharma company. Japan is the most sophisticated cell therapy market, with a high number of potential partners and an appealing accelerated pathway to market. The Roquefort Therapeutics Board has the personal experience and a strong network from completing deals with Japan Big Pharma. We have initiated these discussions and will update the market in due course" ENDS Roquefort Therapeutics plc +44 (0)20 3918 8633 Stephen West (Chairman) / Ajan Reginald (CEO) SP Angel Corporate Finance LLP (Broker) David Hignell / Vadim Alexandre / Devik Mehta +44 (0) 20 3470 0470 Buchanan (Public Relations) Ben Romney / Jamie Hooper / George Beale +44 (0)20 7466 5000 Peak IR (Investor Relations) Seb Wykeham +33 (0)7 44 44 15 42 LEI: ‎254900P4SISIWOR9RH34 About Roquefort Therapeutics Roquefort Therapeutics (LSE:ROQ) is a Main Market listed biotech company developing first in class drugs in the high value and high growth immunology and oncology markets prior to partnering or selling to big pharma. Roquefort Therapeutics' portfolio consists of five novel patent-protected pre-clinical anti-cancer medicines. The highly complementary profile of five best-in-class medicines consists of: · Midkine antibodies with significant in vivo efficacy and toxicology studies; · Midkine RNA therapeutics with novel anti-cancer gene editing action; · Midkine mRNA therapeutics with novel anti-cancer approach; · STAT-6 siRNA therapeutics targeting solid tumours with significant in vivo efficacy; and · MK cell therapy with direct and NK cell-mediated anti-cancer action For further information on Roquefort Therapeutics, please visit www.roquefortplc.com and @RoquefortTherap on X (formerly Twitter). [i] which is different from any other cell type including MSCs and includes expression of CD16, CD96, CD112, CD137L, FasL, TRAIL and CD277 and some NK cell [ii] L. Chapman, J. Abdi, S. Galvez-Peisl, A. Keating, Immunophenotypic and functional characterization of Mesodermal Killer (MK) cells: a novel cell type and potential cellular therapy for cancer Cytotherapy, Volume 22, Issue 5, Supplement, 2020, Page S121, ISSN 1465-3249, https://doi-org.libproxy1.nus.edu.sg/10.1016/j.jcyt.2020.03.226. [iii] https://www-tandfonline-com.libproxy1.nus.edu.sg/doi/full/10.1080/14712598.2022.2093637#d1e2011