{"id":7872,"date":"2024-10-15T00:00:01","date_gmt":"2024-10-15T07:00:01","guid":{"rendered":"https:\/\/rakuten-med.com\/us\/?post_type=press_releases&#038;p=7872"},"modified":"2024-12-05T18:13:37","modified_gmt":"2024-12-06T02:13:37","slug":"commencement-of-investigator-initiated-trial-iit-of-photoimmunotherapy-in-gynecologic-cancers-in-japan","status":"publish","type":"press_releases","link":"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2024\/10\/15\/7872\/","title":{"rendered":"Commencement of Investigator-Initiated Trial (IIT) of Photoimmunotherapy in Gynecologic Cancers in Japan"},"content":{"rendered":"<div id=\"pl-7872\"  class=\"panel-layout\" ><div id=\"pg-7872-0\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 60px\" ><div id=\"pgc-7872-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7872-0-0-0\" class=\"so-panel widget widget_sow-editor panel-first-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>First clinical trial of photoimmunotherapy for gynecologic cancers<\/i><\/b><\/li>\n<li><b><i>Study funded by the Japan Agency for Medical Research and Development (AMED)<\/i><\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">Hokkaido University Hospital has begun patient enrollment in Japan for an investigator-initiated clinical trial (IIT) of photoimmunotherapy in gynecologic cancers on October 1 (Japan time). Rakuten Medical, Inc. will provide investigational drug and medical devices for this IIT.<\/span><\/p>\n<p><span style=\"font-weight: 400\">This Phase 2, single-arm, open-label IIT (jRCT2011240034) is designed to evaluate the safety and efficacy of ASP-1929 photoimmunotherapy for locally advanced or recurrent vulvar, vaginal, and cervical cancers. The study program has been selected for funding by the Japan Agency for Medical Research and Development (AMED).<\/span><\/p>\n<p><span style=\"font-weight: 400\">The investigational drug and devices used in this IIT have previously been approved by Japan\u2019s Ministry of Health, Labour and Welfare for unresectable locally advanced or recurrent head and neck cancer under the Conditional Early Approval System. This IIT marks the world's first clinical trial to investigate photoimmunotherapy using the drug and devices for gynecologic cancers.<\/span><\/p>\n<p><i><span style=\"font-weight: 400\">Disclaimer: Rakuten Medical\u2019s photoimmunotherapy based on the Alluminox\u2122 platform are investigational outside Japan.<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400\">Vulvar, vaginal, and cervical cancers have an estimated annual incidence in Japan of 250, 150, and 10,000 cases, respectively.<\/span><sup>1<\/sup><span style=\"font-weight: 400\"> These cancers are predominantly squamous cell carcinomas, with 70-95% of cases showing epidermal growth factor receptor (EGFR) positivity.<\/span><sup>2-4<\/sup><span style=\"font-weight: 400\"> This profile is similar to that of head and neck cancers, which are also mainly squamous cell carcinomas and more than 90% EGFR-positive.<\/span><sup>5<\/sup><span style=\"font-weight: 400\"> Due to the accessible location of these cancers to the body surface, laser illumination in photoimmunotherapy is expected to be technically feasible.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Dr. Hidemichi Watari, Professor of Gynecology at Hokkaido University Hospital, and principal investigator of the IIT, commented:<br \/>\n<\/span><span style=\"font-weight: 400\">\u201cExisting treatment options for recurrent or advanced vulvar, vaginal, and cervical cancers often yield limited outcomes and may significantly impact patients\u2019 quality of life. In cervical cancer, one of the most prevalent gynecologic cancers, high EGFR expression correlates with a poor prognosis, highlighting the need for new, targeted therapies. We are hopeful that the selective targeting mechanism of photoimmunotherapy may provide a new treatment option and offer a ray of hope for patients battling these challenging cancers.\u201d<\/span><\/p>\n<\/div>\n<\/div><\/div><div id=\"panel-7872-0-0-1\" class=\"so-panel widget widget_sow-editor 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<ol style=\"font-size: 0.8em\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The Japanese Society for Obstetrics and Gynecology, Gynecologic Ulcer Committee, Patient Annual Report, 2018-2020 <\/span><a href=\"https:\/\/www.jsog.or.jp\/modules\/committee\/index.php?content_id=7#databook\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">https:\/\/www.jsog.or.jp\/modules\/committee\/index.php?content_id=7#databook<\/span><\/a><span style=\"font-weight: 400\"> (2019-2021)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Garganese, G. et al. The Vulvar Immunohistochemical Panel (VIP) Project: Molecular Profiles of Vulvar Squamous Cell Carcinoma. Cancers (Basel) 13 (2021). <\/span><span style=\"font-weight: 400\">https:\/\/doi.org:10.3390\/cancers13246373<\/span><\/li>\n<li><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Brunner, A. et al. Expression of epidermal growth factor receptor and vascular endothelial growth factor in vaginal squamous cell cancer. Am J Obstet Gynecol 204, 171 e171-176 (2011). <\/span><span style=\"font-weight: 400\">https:\/\/doi.org:10.1016\/j.ajog.2010.09.031<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">proteinatlas.org, H. P. A. EGFR, cervical cancer, Human pathology, Human Protein Atlas, <\/span><a href=\"https:\/\/www.proteinatlas.org\/ENSG00000146648-EGFR\/pathology\/cervical+cancer#ihc\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">https:\/\/www.proteinatlas.org\/ENSG00000146648-EGFR\/pathology\/cervical+cancer#ihc<\/span><\/a><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Assuntina G Sacco et al. Current Treatment Options for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. 2015; 33(29):3305-13<\/span><\/li>\n<\/ol>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7872-1\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7872-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7872-1-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"2\" ><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><b>About Rakuten Medical<br \/>\n<\/b><span style=\"font-weight: 400\">Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary Alluminox\u2122 platform, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical\u2019s photoimmunotherapy based on the Alluminox platform are 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 photoimmunotherapy using the Alluminox platform, 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 the surface of targeted cells, such as tumor cells.\u00a0The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug.\u00a0Rakuten 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.\u00a0Hisataka Kobayashi\u00a0and team from the National Cancer Institute in\u00a0the United States. Outside Japan, Rakuten Medical\u2019s photoimmunotherapy based on the Alluminox platform are investigational.<\/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<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7872-2\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-7872-2-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7872-2-0-0\" 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-7872-2-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-button so-widget-sow-button-flat-6fd36f18507f-7872\"\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>First clinical trial of photoimmunotherapy for gynecologic cancers Study funded by the Japan Agency for Medical Research and Development (AMED) [&hellip;]<\/p>\n","protected":false},"author":13,"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-7872","1":"press_releases","2":"type-press_releases","3":"status-publish","5":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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