{"id":7788,"date":"2024-01-22T16:30:55","date_gmt":"2024-01-23T00:30:55","guid":{"rendered":"https:\/\/rakuten-med.com\/us\/?post_type=press_releases&#038;p=7788"},"modified":"2024-01-22T20:19:37","modified_gmt":"2024-01-23T04:19:37","slug":"rakuten-medical-announces-global-phase-3-of-asp-1929-treats-first-patients-in-india","status":"publish","type":"press_releases","link":"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2024\/01\/22\/7788\/","title":{"rendered":"Rakuten Medical Announces First Patient Treatment in India in Global Phase 3 Trial of Alluminox Treatment (Photoimmunotherapy) using ASP-1929 for Recurrent Head and Neck Cancer"},"content":{"rendered":"<div id=\"pl-7788\"  class=\"panel-layout\" ><div id=\"pg-7788-0\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-7788-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7788-0-0-0\" 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<p><i><b>- A potential new innovative treatment option for head and neck cancers with high unmet needs<\/b><\/i><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400\">Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox\u2122 platform, today announced that the first patient in India received study treatment in August 2023 under Rakuten Medical\u2019s global, pivotal Phase 3 clinical trial (ASP-1929-301 study \/ ClinicalTrials.gov Identifier: <\/span><a href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT03769506\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">NCT03769506<\/span><\/a><span style=\"font-weight: 400\">, CTRI Number: <\/span><a href=\"https:\/\/ctri.nic.in\/Clinicaltrials\/showallp.php?mid1=84344&amp;EncHid=&amp;userName=CTRI\/2023\/05\/052728\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">CTRI\/2023\/05\/052728<\/span><\/a><span style=\"font-weight: 400\">) of Alluminox treatment (photoimmunotherapy) using ASP-1929 for patients with locoregional, recurrent head and neck squamous cell carcinomas (HNSCC). The ASP-1929-301 study is currently ongoing in countries and regions including the United States, India and Taiwan, and will enroll a total of 275 patients globally. In India, six leading medical institutions are currently participating in the ASP-1929-301 study.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400\">Alluminox treatment is gaining increasing interest in India as the trial progresses, and two physicians were invited from Japan to present their extensive experiences using this treatment at the 23<\/span><sup>rd<\/sup><span style=\"font-weight: 400\"> National Conference of Foundation for Head and Neck Oncology, held in Daman, India, on December 22-24, 2023. For details, please see the <\/span><a href=\"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2024\/01\/22\/7795\/\"><span style=\"font-weight: 400\">press release<\/span><\/a><span style=\"font-weight: 400\">.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400\">In India, more than 200,000 new cases of head and neck cancer are diagnosed each year, which accounts for approximately 25% of all new head and neck cancer cases worldwide<\/span><sup>1<\/sup><span style=\"font-weight: 400\">. In addition to the high occurrence of head and neck cancer, the majority of these patients present with advanced disease, which also corresponds with poorer outcomes<\/span><sup>2<\/sup><span style=\"font-weight: 400\">. Such high volumes of advanced stage patients can present many challenges for surgeons and medical oncologists who treat head and neck cancer, as treatment options for such patients are limited. Surgery, radiation, and chemotherapy are all commonly used to manage this patient population \u2013 but more options are needed.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400\">Dr. Subramania Iyer K., an investigator for the ASP-1929-301 study at the Amrita Institute of Medical Sciences and Research Centre (Kochi), stated in an interview conducted by Rakuten Medical in July 2023, \u201cWhen we had discussion about it (Alluminox treatment), we thought it was one of the most innovative ideas which we should try to implement and look at it. I hope and I'm sure that this will make a lot of difference in the way we treat cancers in the future.\u201d<\/span><\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div><\/div><div id=\"panel-7788-0-0-1\" class=\"widget_text so-panel widget widget_custom_html\" data-index=\"1\" ><div class=\"textwidget custom-html-widget\"><iframe width=\"1280\" height=\"720\" src=\"https:\/\/www.youtube.com\/embed\/lT4NriAoDpc\" title=\"[English] Rakuten Medical&#39;s interview with Dr  Subramania Iyer K\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" allowfullscreen><\/iframe><\/div><\/div><div id=\"panel-7788-0-0-2\" class=\"so-panel widget widget_sow-editor\" 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>&nbsp;<\/p>\n<p><span style=\"text-decoration: underline;\"><b>About ASP-1929-301 study<br \/>\n<\/b><\/span><span style=\"font-weight: 400;\">The multi-center, randomized, open-label, global Phase 3 study of Alluminox treatment using ASP-1929 will evaluate the efficacy and safety of ASP-1929 in patients with locoregional, recurrent HNSCC who have previously failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy, and are not eligible for surgery or radiation. Participants will be randomized to receive experimental therapy or investigator\u2019s choice of systemic therapy (2:1). The dual primary endpoints of the study are progression-free survival and overall survival, and the key secondary endpoint is objective response rate.<\/span><\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div><\/div><div id=\"panel-7788-0-0-3\" class=\"so-panel widget widget_sow-image\" data-index=\"3\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-image so-widget-sow-image-default-c67d20f9f743-7788\"\n\t\t\t\n\t\t>\n<div class=\"sow-image-container\">\n\t\t<img \n\tsrc=\"https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2024\/01\/EN-301-study-site-map.png\" width=\"1280\" height=\"720\" srcset=\"https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2024\/01\/EN-301-study-site-map.png 1280w, https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2024\/01\/EN-301-study-site-map-300x169.png 300w, https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2024\/01\/EN-301-study-site-map-1024x576.png 1024w, https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2024\/01\/EN-301-study-site-map-768x432.png 768w\" sizes=\"(max-width: 1280px) 100vw, 1280px\" title=\"EN-301 study site map\" alt=\"ASP-1929-301 study is the multi-center, randomized, open-label, global Phase 3 study of Alluminox treatment (photoimmunotherapy) using ASP-1929 which will evaluate the efficacy and safety of ASP-1929 in patients with locoregional, recurrent head and neck squamous cell carcinoma (HNSCC) .\" \t\tclass=\"so-widget-image\"\/>\n\t<\/div>\n\n<\/div><\/div><div id=\"panel-7788-0-0-4\" class=\"so-panel widget widget_sow-editor\" data-index=\"4\" ><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><small>1. <span style=\"font-weight: 400\">Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Pi\u00f1eros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: <\/span><a href=\"https:\/\/gco.iarc.fr\/today\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">https:\/\/gco.iarc.fr\/today<\/span><\/a><span style=\"font-weight: 400\">, accessed Dec 13, 2023<\/span><\/small><\/p>\n<p><small>2. <span style=\"font-weight: 400\">Kulkarni MR. Head and Neck Cancer Burden in India. Int J Head and Neck Surg 2013;4(1):29-35 <\/span><a href=\"https:\/\/www.ijhns.com\/doi\/pdf\/10.5005\/jp-journals-10001-1132\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">https:\/\/www.ijhns.com\/doi\/pdf\/10.5005\/jp-journals-10001-1132<\/span><\/a><\/small><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div><\/div><div id=\"panel-7788-0-0-5\" class=\"so-panel widget widget_sow-editor\" data-index=\"5\" ><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, Inc.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox\u2122 platform, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing and tumor necrosis. Alluminox therapies have not yet been approved outside of Japan. Rakuten Medical is committed to its mission to conquer cancer by developing our innovative treatments as quickly as possible for patients all over the world. The company has offices in 5 countries, 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>&nbsp;<\/p>\n<p><b>About Alluminox\u2122 platform<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The Alluminox\u2122 platform is an investigational technology platform based on a cancer therapy called photoimmunotherapy, which was developed by Dr.<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">Hisataka Kobayashi<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">and team from the National Cancer Institute in<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">the United States. Rakuten Medical is developing the Alluminox platform as a technology consisting of a drug, device, and other related components. The drug component of the platform consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding.<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">The device component consists of a light source that locally illuminates the targeted cells with light to transiently activate the drug.<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">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 cancer cells and\/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Outside of<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">Japan, Alluminox therapies have not yet been approved by any regulatory authority.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>About ASP-1929<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Rakuten Medical\u2019s first pipeline drug developed on its Alluminox\u2122 platform is ASP-1929, an antibody-dye conjugate comprised of the antibody cetuximab and IRDye\u00ae 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination emitted by a laser device system, resulting in photochemical reaction.<\/span> <span style=\"font-weight: 400;\">This is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. ASP-1929 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) in January 2018, and is currently under investigation in a global Phase 3 clinical trial for recurrent head and neck cancer. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. Outside of Japan, ASP-1929 has not yet been approved by any regulatory authority.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>Forward Looking Statements<\/b><\/p>\n<p><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>&nbsp;<\/p>\n<\/div>\n<\/div><\/div><div id=\"panel-7788-0-0-6\" class=\"so-panel widget widget_sow-button panel-last-child\" data-index=\"6\" ><div style=\"padding: 30px 0px 0px 0px;\" class=\"panel-widget-style panel-widget-style-for-7788-0-0-6\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-button so-widget-sow-button-flat-eb5ca29d5259-7788\"\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>&#8211; A potential new innovative treatment option for head and neck cancers with high unmet needs &nbsp; Rakuten Medical, Inc., [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":7791,"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-7788","1":"press_releases","2":"type-press_releases","3":"status-publish","4":"has-post-thumbnail","6":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Rakuten Medical Announces First Patient Treatment in India in Global Phase 3 Trial of Alluminox Treatment (Photoimmunotherapy) using ASP-1929 for Recurrent Head and Neck Cancer - Rakuten Medical - To conquer cancer.<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2024\/01\/22\/7788\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Rakuten Medical Announces First Patient Treatment in India in Global Phase 3 Trial of Alluminox Treatment (Photoimmunotherapy) using ASP-1929 for Recurrent Head and Neck Cancer - Rakuten Medical - To conquer cancer.\" \/>\n<meta property=\"og:description\" content=\"- A potential new innovative treatment option for head and neck cancers with high unmet needs &nbsp; 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