{"id":7891,"date":"2025-05-22T16:00:10","date_gmt":"2025-05-22T23:00:10","guid":{"rendered":"https:\/\/rakuten-med.com\/us\/?post_type=press_releases&#038;p=7891"},"modified":"2025-05-26T00:08:08","modified_gmt":"2025-05-26T07:08:08","slug":"rakuten-medical-announces-trial-in-progress-poster-presentation-at-asco-2025-and-enrollment-expansion-to-taiwan-for-global-phase-3-asp-1929-381","status":"publish","type":"press_releases","link":"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2025\/05\/22\/7891\/","title":{"rendered":"Rakuten Medical Announces Trial in Progress Poster Presentation at ASCO 2025 and Enrollment Expansion to Taiwan for Global Phase 3 ASP-1929-381"},"content":{"rendered":"<div id=\"pl-7891\"  class=\"panel-layout\" ><div id=\"pg-7891-0\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7891-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7891-0-0-0\" 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><em><strong>Poster presentation to highlight the ongoing global Phase 3 ASP-1929-381 study at ASCO 2025<\/strong><\/em><\/li>\n<li><em><strong>Global patient enrollment continues, with Taiwan now actively enrolling following the U.S., and Japan expected to follow as part of global study start-up<\/strong><\/em><\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7891-1\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7891-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7891-1-0-0\" 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 it will present a Trial in Progress poster at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place May 30 \u2013 June 3, 2025, in Chicago, Illinois.<\/span><\/p>\n<p><span style=\"font-weight: 400\">The poster will feature Rakuten Medical\u2019s ongoing global Phase 3 clinical trial evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab (anti-PD-1) as a first-line therapy for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 \/ Acronym: ECLIPSE \/ ClinicalTrials.gov Identifier: <\/span><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT06699212\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">NCT06699212<\/span><\/a><span style=\"font-weight: 400\">). The poster will also highlight <a href=\"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2024\/05\/24\/7847\/\">interim findings<\/a> from the completed Phase 1b\/2 study (ASP-1929-181 \/ ClinicalTrials.gov Identifier:<\/span> <a href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04305795\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">NCT04305795<\/span><\/a><span style=\"font-weight: 400\">) which evaluated ASP-1929 photoimmunotherapy in combination with anti-PD-1 in recurrent or metastatic HNSCC.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">\u201cWe are honored that our Trial in Progress poster has been accepted for presentation at ASCO 2025,\u201d said Anastasios Maniakas, MD, PhD, Assistant Professor in the Department of Head and Neck Surgery and an investigator of the ASP-1929-381 study at The University of Texas MD Anderson Cancer Center. \u201cThis Phase 3 study represents a significant step forward in evaluating the potential synergistic efficacy of ASP-1929 photoimmunotherapy and pembrolizumab as a first-line treatment for patients with recurrent HNSCC. We look forward to sharing our progress with the global oncology community and advancing innovative approaches for the treatment of patients facing this challenging disease.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400\">Rakuten Medical is also pleased to announce that it has recently initiated patient enrollment in Taiwan as part of its global expansion of the Phase 3 ASP-1929-381 study. Currently, over 10 clinical sites across the United States and Taiwan are actively enrolling patients. Additional sites are expected to be activated in both regions, with patient enrollment in Japan anticipated to begin shortly.<\/span><\/p>\n<p><span style=\"font-weight: 400\">\u201cWe are pleased to be part of this global Phase 3 study and to contribute to the development of an innovative treatment approach like photoimmunotherapy,\u201d said Kai-Ping Chang, MD, PhD, Professor of the Department of Otolaryngology - Head &amp; Neck Surgery and Principal Investigator of the ASP-1929-381 study at Chang Gung Memorial Hospital in Taiwan. \u201cHead and neck cancer ranks third in male cancer incidence and fourth in male cancer mortality in Taiwan<\/span><sup>1<\/sup><span style=\"font-weight: 400\">. Local recurrence or metastasis is one of the leading causes of death in these patients<\/span><sup>2<\/sup><span style=\"font-weight: 400\">, and nearly half of those with recurrent or metastatic disease survive for less than one year<\/span><sup>3<\/sup><span style=\"font-weight: 400\">. By participating in this trial, we hope to help advance new therapeutic options that may prolong overall survival of patients with recurrent HNSCC, both in Taiwan and around the world.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400\">ASCO attendees are invited to visit Rakuten Medical at booth #33110 to learn more about the ASP-1929-381 study and the company\u2019s broader Alluminox\u2122 platform.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"text-decoration: underline\"><b>Rakuten Medical\u2019s Trial in Progress Poster Overview<\/b><\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Abstract Title:<\/b><span style=\"font-weight: 400\"> A phase 3 randomized study of ASP-1929 photoimmunotherapy in combination with pembrolizumab versus standard of care in locoregional recurrent head and neck squamous cell carcinoma (HNSCC)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Abstract Number:<\/b><span style=\"font-weight: 400\"> TPS6122<\/span><\/li>\n<li><strong>Abstract Link:<\/strong> <a href=\"https:\/\/meetings.asco.org\/abstracts-presentations\/253337\" target=\"_blank\" rel=\"noopener\">https:\/\/meetings.asco.org\/abstracts-presentations\/253337<\/a><\/li>\n<li style=\"font-weight: 400\"><b>Session:<\/b> <span style=\"font-weight: 400\">Poster Session \u2013 <\/span><span style=\"font-weight: 400\">Head and Neck Cancer<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Date:<\/b><span style=\"font-weight: 400\"> Monday, June 2, 2025<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Time:<\/b><span style=\"font-weight: 400\"> 9:00 a.m. \u2013 12:00 p.m., CDT<\/span><\/li>\n<li style=\"font-weight: 400\"><b>First Author:<\/b><span style=\"font-weight: 400\"> Anastasios Maniakas, The University of Texas MD Anderson Cancer Center, TX, the U.S.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Location:<\/b><span style=\"font-weight: 400\"> Exhibit Hall A, Poster Board #<\/span> <span style=\"font-weight: 400\">523b<\/span><\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline\"><b>Rakuten Medical Exhibit Booth<\/b><\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Location:<\/b><span style=\"font-weight: 400\"> Exhibit Hall A, Booth #33110<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Exhibit Date:<\/b><span style=\"font-weight: 400\"> Saturday \u2013 Monday, May 31 \u2013 June 2, 2025<\/span><\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline\"><b>About ASP-1929-381 Study<\/b><\/span><\/p>\n<p>The ASP-1929-381 study is a multi-regional multi-center, randomized, open-label Phase 3 trial, designed to assess the efficacy and safety of ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC without distant metastases. 412 patients globally will be randomized to either an experimental arm receiving ASP-1929 photoimmunotherapy in combination with pembrolizumab, or a control arm receiving the current pembrolizumab-based standard of care (SOC), where patients may receive pembrolizumab alone or in combination with chemotherapy according to the physician's choice.<br \/>\nThe primary endpoint is Overall Survival (OS), with key secondary endpoints including Complete Response Rate (CRR) and Overall Response Rate (ORR).<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7891-2\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 60px\" ><div id=\"pgc-7891-2-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7891-2-0-0\" class=\"so-panel widget widget_sow-image panel-first-child panel-last-child\" data-index=\"2\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-image so-widget-sow-image-default-c67d20f9f743-7891\"\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\/2025\/05\/EN-381-map.png\" width=\"1280\" height=\"720\" srcset=\"https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2025\/05\/EN-381-map.png 1280w, https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2025\/05\/EN-381-map-300x169.png 300w, https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2025\/05\/EN-381-map-1024x576.png 1024w, https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2025\/05\/EN-381-map-768x432.png 768w\" sizes=\"(max-width: 1280px) 100vw, 1280px\" title=\"EN-381 map\" alt=\"\" \t\tclass=\"so-widget-image\"\/>\n\t<\/div>\n\n<\/div><\/div><\/div><\/div><div id=\"pg-7891-3\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7891-3-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7891-3-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"3\" ><div class=\"panel-widget-style panel-widget-style-for-7891-3-0-0\" ><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>111th Taiwan Cancer Registry Report, National Health Service, Ministry of Health and Welfare<\/li>\n<li>A Novel CXCR4-Targeted Diphtheria Toxin Nanoparticle Inhibits Invasion and Metastatic Dissemination in a Head and Neck Squamous Cell Carcinoma Mouse Model. Pharmaceutics. 2022 Apr 18;14(4):887. doi:10.3390\/pharmaceutics14040887<\/li>\n<li>Argiris A, Harrington KJ, Tahara M, Schulten J, Chomette P, Ferreira Castro A, Licitra L. Evidence-Based Treatment Options in Recurrent and\/or Metastatic Squamous Cell Carcinoma of the Head and Neck. Front Oncol. 2017 May 9;7:72. doi: 10.3389\/fonc.2017.00072.<\/li>\n<\/ol>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><div id=\"pg-7891-4\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7891-4-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7891-4-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" 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><strong>About Rakuten Medical, Inc.<br \/>\n<\/strong>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 <a href=\"http:\/\/www.rakuten-med.com\">www.rakuten-med.com<\/a>.<\/p>\n<p><strong>About Alluminox\u2122 platform<br \/>\n<\/strong>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.<\/p>\n<p><strong>About ASP-1929<br \/>\n<\/strong>Rakuten Medical\u2019s first pipeline drug developed on its Alluminox\u2122 platform is ASP-1929, an antibody-dye conjugate comprised of the anti-EGFR 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 illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. 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. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority.<\/p>\n<p><a href=\"https:\/\/www.prnewswire.com\/news-releases\/rakuten-medical-announces-trial-in-progress-poster-presentation-at-asco-2025-and-enrollment-expansion-to-taiwan-for-global-phase-3-asp-1929-381-302463811.html?tc=eml_cleartime\" target=\"_blank\" rel=\"noopener\">PR Newswire<\/a><\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7891-5\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-7891-5-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7891-5-0-0\" class=\"so-panel widget widget_sow-button panel-first-child panel-last-child\" data-index=\"5\" ><div style=\"padding: 30px 0px 0px 0px;\" class=\"panel-widget-style panel-widget-style-for-7891-5-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-button so-widget-sow-button-flat-6fd36f18507f-7891\"\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>Poster presentation to highlight the ongoing global Phase 3 ASP-1929-381 study at ASCO 2025 Global patient enrollment continues, with Taiwan [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":7899,"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-7891","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 v27.7 - 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To conquer cancer.\",\"description\":\"Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox\u2122TM technology platform. 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