{"id":7895,"date":"2025-06-04T16:00:42","date_gmt":"2025-06-04T23:00:42","guid":{"rendered":"https:\/\/rakuten-med.com\/us\/?post_type=press_releases&#038;p=7895"},"modified":"2025-06-04T18:18:17","modified_gmt":"2025-06-05T01:18:17","slug":"rakuten-medical-announces-trial-in-progress-poster-presentation-at-asco-2025-and-enrollment-expansion-to-taiwan-for-global-phase-3-asp-1929-381-2","status":"publish","type":"press_releases","link":"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2025\/06\/04\/7895\/","title":{"rendered":"Rakuten Medical\u2019s Anti-PD-L1 Antibody-IR700 Conjugate, RM-0256, Selected for AMED Funding"},"content":{"rendered":"<div id=\"pl-7895\"  class=\"panel-layout\" ><div id=\"pg-7895-0\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7895-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7895-0-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<ul>\n<li><b><i>AMED grant to support the clinical development of RM-0256 photoimmunotherapy for targeting malignant epithelial tumors<\/i><\/b><\/li>\n<li><b><i>Targeting PD-L1, pre-clinical observations indicate RM-0256 harnesses a triple mechanism of action, with potential applications across a broad range of solid tumors, including melanoma, ocular melanoma, urologic, and breast cancers <\/i><\/b><b><i><sup>2<\/sup><\/i><\/b><\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7895-1\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7895-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7895-1-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"1\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p><span style=\"font-weight: 400;\">Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox\u2122 platform-based photoimmunotherapy, today announced that its third drug candidate, RM-0256, has been selected for funding by the Japan Agency for Medical Research and Development (AMED) under its <\/span><a href=\"https:\/\/www.amed.go.jp\/en\/program\/list\/11\/02\/001_03-01.html\" target=\"_blank\" rel=\"noopener\"><i><span style=\"font-weight: 400;\">Support Program for Orphan Drug prior to the Designation<\/span><\/i><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">RM-0256 is a novel antibody conjugate composed of IRDye\u00ae700DX (IR700)\u2014a light-activatable dye for which Rakuten Medical holds exclusive global manufacturing and supply rights\u2014and a proprietary anti-PD-L1 monoclonal antibody. The AMED funding will support the clinical development of RM-0256 photoimmunotherapy for unresectable, advanced, or recurrent malignant epithelial tumors.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In Japan, malignant epithelial tumors affect approximately 22,000 individuals annually<sup>1<\/sup>. While systemic therapies, including chemotherapy and immune checkpoint inhibitors, are currently the mainstay of treatment for unresectable advanced or recurrent cases, patients who develop resistance to these treatments face limited treatment options, which underscores the urgent need for novel therapeutic approaches.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">RM-0256 targets Programmed Cell Death Ligand 1 (PD-L1), a key immune checkpoint protein that allows tumors to evade immune detection by binding to PD-1 receptors on activated T cells. PD-L1 is widely expressed in various solid tumors\u2014including melanoma, ocular melanoma, lung, urothelial, gastrointestinal, gynecological, breast, and head and neck cancers<\/span><sup>2<\/sup><span style=\"font-weight: 400;\">\u2014as well as on immunosuppressive cells within the tumor microenvironment.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Pre-clinical studies of PD-L1-targeted photoimmunotherapy have suggested three complementary mechanisms of action<\/span><sup>3<\/sup><span style=\"font-weight: 400;\">:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Direct depletion (necrosis) of PD-L1-expressing tumor cells;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Activation of anti-tumor immunity through the elimination of PD-L1\u2013expressing immunosuppressive cells;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Checkpoint blockade, by inhibiting PD-L1\/PD-1 interaction, potentially enhancing systemic immune responses.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">With the support of AMED funding, Rakuten Medical is accelerating the development of RM-0256 photoimmunotherapy as a novel, multimodal cancer therapy that may induce both local and systemic anti-tumor effects.<\/span><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7895-2\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7895-2-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7895-2-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"2\" ><div class=\"panel-widget-style panel-widget-style-for-7895-2-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p><em>Disclaimer: Rakuten Medical\u2019s Alluminox\u2122 platform-based photoimmunotherapy is investigational outside Japan.<\/em><\/p>\n<ol>\n<li style=\"font-weight: 400\"><i><span style=\"font-weight: 400\">Cancer Incidence of Japan 2020<\/span><\/i><span style=\"font-weight: 400\">, Cancer and Disease Control Division, Ministry of Health, Labour and Welfare <\/span><a href=\"https:\/\/www.mhlw.go.jp\/content\/10900000\/001231386.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">https:\/\/www.mhlw.go.jp\/content\/10900000\/001231386.pdf<\/span><\/a><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Kythreotou A, Siddique A, Mauri FA, et alPD-L1Journal of Clinical Pathology 2018;71:189-194. <\/span><a href=\"https:\/\/jcp.bmj.com\/content\/71\/3\/189\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">https:\/\/jcp.bmj.com\/content\/71\/3\/189<\/span><\/a><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Thorne A. PD-L1 photoimmunotherapy kills immunosuppressive myeloid cells to activate local and systemic antitumor immunity. Abstract Number: 30050. The 83rd Annual Meeting of the Japanese Cancer Association. September 2024. <a href=\"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2024\/09\/19\/7864\/\">https:\/\/rakuten-med.com\/us\/news\/press-releases\/2024\/09\/19\/7864\/<\/a><\/span><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p><b>About Rakuten Medical, Inc.<br \/>\n<\/b><span style=\"font-weight: 400\">Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox\u2122 platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical\u2019s photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries\/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit <\/span><a href=\"http:\/\/www.rakuten-med.com\"><span style=\"font-weight: 400\">www.rakuten-med.com<\/span><\/a><span style=\"font-weight: 400\">.<\/span><\/p>\n<p><b>About Alluminox\u2122 platform<br \/>\n<\/b><span style=\"font-weight: 400\">The Alluminox\u2122 platform is Rakuten Medical\u2019s investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye\u00ae 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical\u2019s pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and\/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical\u2019s Alluminox platform-based photoimmunotherapy is investigational.<\/span><\/p>\n<p><b>About RM-0256<br \/>\n<\/b><span style=\"font-weight: 400\">RM-0256 is an antibody conjugate comprised of a proprietary anti-PD-L1 monoclonal antibody (immune checkpoint inhibitor) and IRDye\u00ae 700DX, a light-activatable dye, that has been developed by Rakuten Medical to specifically target PD-L1-expressing cells. PD-L1 is an immune checkpoint protein that inhibits anti-tumor T cell responses by binding to PD-1 on activated T cells. It is widely expressed in many solid tumors, and is expressed on both tumor cells and immunosuppressive cells within the tumor microenvironment such as tumor-associated macrophages (TAMs) and myeloid- derived suppressor cells (MDSCs). Pre-clinical studies of PD-L1-targeted photoimmunotherapy have suggested activation of anti-tumor immune responses by destruction of target tumor cells and elimination of immunosuppressive cells. Inhibition of PD-L1\/PD-1 binding has been also demonstrated, which may amplify the anti-tumor immune response.<\/span><\/p>\n<p><b>Forward Looking Statements<br \/>\n<\/b><span style=\"font-weight: 400\">This press release contains forward looking statements that correspond to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include various risks, uncertainties, and assumptions that may cause Rakuten Medical\u2019s business plans and results to differ from the anticipated results and expectations expressed in these statements. These \u201cforward looking statements\u201d contain information about the status and development of our products, including the Alluminox\u2122 platform, as well as other regulatory and marketing authorization efforts, the potential benefits, efficacy, and safety of therapies created using the Alluminox platform, and the status of regulatory filings. The approval and commercial success of the product may not be achieved. Forward looking statements relate to the potential benefits, efficacy, and safety of our therapies, and the status of regulatory filings. Such statements may include words such as \u201cexpect,\u201d \u201cbelieve,\u201d \u201chope,\u201d \u201cestimate,\u201d \u201clooks as though,\u201d \u201canticipate,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201csuggest,\u201d \u201cplan,\u201d \u201cstrategy,\u201d \u201cwill,\u201d and \u201cdo\u201d, and are based on our current beliefs. In addition, this press release uses terms such as \u201cimportant,\u201d \u201cnotable,\u201d and \u201cabnormal\u201d to express opinions about clinical trial data. Ongoing clinical trial studies include various risks and uncertainties, in particular, problems that arise during the manufacturing stage of our therapies, the occurrence of adverse safety events, situations in failure to demonstrate therapeutic benefits, and other various risks and uncertainties, both reasonable and unreasonable. For this reason, actual results, including regulatory approvals and uncertainties in the commercialization process of our therapies, may differ from published information. Except to the extent required by applicable law, we undertake no obligation to publicly update this or any other forward-looking statement, whether because of new information, future developments or events, changes in assumptions, changes in the factors affecting forward-looking statements. If one or more forward-looking statement(s) is updated, no inference should be drawn that additional updates will be made to those or other forward-looking statements.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/www.prnewswire.com\/news-releases\/rakuten-medicals-anti-pd-l1-antibody-ir700-conjugate-rm-0256-selected-for-amed-funding-302472994.html?tc=eml_cleartime\" target=\"_blank\" rel=\"noopener\">PR Newswire<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><div id=\"pg-7895-3\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-7895-3-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7895-3-0-0\" class=\"so-panel widget widget_sow-button panel-first-child panel-last-child\" data-index=\"3\" ><div style=\"padding: 30px 0px 0px 0px;\" class=\"panel-widget-style panel-widget-style-for-7895-3-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-button so-widget-sow-button-flat-6fd36f18507f-7895\"\n\t\t\t\n\t\t><div class=\"ow-button-base ow-button-align-center\"\n>\n\t\t\t<a\n\t\t\t\t\thref=\"https:\/\/rakuten-med.com\/us\/contact\/\"\n\t\t\t\t\tclass=\"rakuten-btn sowb-button ow-icon-placement-left ow-button-hover\" \t>\n\t\t<span>\n\t\t\t\n\t\t\tContact Us\t\t<\/span>\n\t\t\t<\/a>\n\t<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>AMED grant to support the clinical development of RM-0256 photoimmunotherapy for targeting malignant epithelial tumors Targeting PD-L1, pre-clinical observations indicate [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"template":"","meta":{"_acf_changed":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":""},"class_list":{"0":"post-7895","1":"press_releases","2":"type-press_releases","3":"status-publish","5":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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