{"id":8004,"date":"2026-07-30T18:00:49","date_gmt":"2026-07-31T01:00:49","guid":{"rendered":"https:\/\/rakuten-med.com\/us\/?post_type=press_releases&#038;p=8004"},"modified":"2026-07-30T18:02:23","modified_gmt":"2026-07-31T01:02:23","slug":"new-data-presented-at-ahns-2026-on-the-optimization-of-asp-1929-photoimmunotherapy-treatment-procedures-for-head-and-neck-cancer","status":"publish","type":"press_releases","link":"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2026\/07\/30\/8004\/","title":{"rendered":"New Data Presented at AHNS 2026 on the Optimization of ASP-1929 Photoimmunotherapy Treatment Procedures for Head and Neck Cancer"},"content":{"rendered":"<div id=\"pl-8004\"  class=\"panel-layout\" ><div id=\"pg-8004-0\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-8004-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-8004-0-0-0\" 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><b>\u2014 Real-World Evidence Evaluating the Association Between Treatment Procedures and Effectiveness and Safety \u2014<\/b><\/p>\n<p><i><span style=\"font-weight: 400\">Disclaimer: Rakuten Medical\u2019s Alluminox\u00ae platform-based photoimmunotherapy is investigational outside Japan.<\/span><\/i><\/p>\n<p><b>San Diego, California \u2013 July 30, 2026 \u2013 <\/b><span style=\"font-weight: 400\">Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting Alluminox\u00ae platform-based photoimmunotherapy (PIT), today announced that new data evaluating treatment procedures to optimize ASP-1929 photoimmunotherapy was presented at the American Head &amp; Neck Society 12th International Conference on Head and Neck Cancer (AHNS 2026) in Boston, Massachusetts, USA.<\/span><\/p>\n<p><span style=\"font-weight: 400\">The poster reports findings from an exploratory analysis of the open-label observational study, ASP-1929-401 (<\/span><a href=\"https:\/\/jrct.mhlw.go.jp\/latest-detail\/jRCT1041210120\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">jRCT1041210120<\/span><\/a><span style=\"font-weight: 400\">), which assessed the impact of ASP-1929 PIT procedure on effectiveness and safety in patients with unresectable, locally advanced or recurrent head and neck cancer.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">The poster presenter, Dr. Nobuhiro Hanai, Deputy Director and Chief of the Department of Head and Neck Surgery, Aichi Cancer Center in Japan, who serves as the principal investigator of this study, commented:\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">\u201cPhotoimmunotherapy was first approved and launched as a reimbursed treatment in Japan for head and neck cancer, and over the past five years, we have accumulated valuable real-world clinical experience. This study suggests that treatment procedures may influence clinical outcomes, offering important insights for optimizing clinical practice. We hope these findings will help inform future clinical research not only in Japan, but also globally and across other cancer types\u201d<\/span><\/p>\n<p><b>Overview of the poster presentation at AHNS 2026<\/b><\/p>\n<p><b>Title: <\/b><span style=\"font-weight: 400\">Investigation of Treatment Procedure to Optimize Photoimmunotherapy for Head and Neck Cancer<\/span><\/p>\n<p><b>Presenter: <\/b><span style=\"font-weight: 400\">Dr. Nobuhiro Hanai (Aichi Cancer Center in Japan)<\/span><\/p>\n<p><b>Poster:<\/b> <a href=\"https:\/\/rakuten-med.com\/us\/events\/ahns26\/poster.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">View\/Download Poster [PDF]<\/span><\/a><\/p>\n<p><b>Poster number<\/b><span style=\"font-weight: 400\">: P224<\/span><\/p>\n<p><b>Key findings:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00a0<\/span><b><\/b><b>Effectiveness<br \/>\n<\/b><span style=\"font-weight: 400\">To evaluate the effective illumination range, lesion-based effectiveness based on tumor volume reduction was compared using two different illumination settings: (1) the initial assumption of Frontal Diffuser (FD): 10 mm depth; Cylindrical Diffuser (CD): 10 mm radius with (2) a refined hypothesis informed by physicians\u2019 clinical experience FD: 5 mm depth; CD: 7 mm radius.<\/span><\/p>\n<p><span style=\"font-weight: 400\">The outcomes were compared between lesions in which the entire tumor was completely covered during every laser illumination session and lesions in which tumor coverage was incomplete during at least one illumination session.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Under Setting (1), volume-based complete response (v-CR) rates was 42.9%, and a favorable trend in tumor response* was observed. Under Setting (2), v-CR rate was 58.6%, and tumor response* was significantly improved (p=0.0065).<\/span><\/p>\n<p><span style=\"font-weight: 400\">These findings suggest that more favorable antitumor effects may be achieved when laser illumination sufficiently covers the entire tumor and when a narrower effective illumination range is applied.<\/span><\/p>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div><\/div><div id=\"panel-8004-0-0-1\" class=\"so-panel widget widget_sow-image\" data-index=\"1\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-image so-widget-sow-image-default-113ccd71f3e6-8004\"\n\t\t\t\n\t\t><h3 class=\"widget-title\">Effective illumination range<\/h3>\n<div class=\"sow-image-container\">\n\t\t<img \n\tsrc=\"https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2026\/07\/Effective-illumination-range.png\" width=\"523\" height=\"337\" srcset=\"https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2026\/07\/Effective-illumination-range.png 523w, https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2026\/07\/Effective-illumination-range-300x193.png 300w\" sizes=\"(max-width: 523px) 100vw, 523px\" title=\"Effective illumination range\" alt=\"\" \t\tclass=\"so-widget-image\"\/>\n\t<\/div>\n\n<\/div><\/div><div id=\"panel-8004-0-0-2\" class=\"so-panel widget widget_sow-editor 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 style=\"text-align: center;font-size: 0.8em\"><span style=\"font-weight: 400\">Reference: AHNS 2026 Immunotherapy \/ Systemic Therapy P224<\/span><\/p>\n<ul>\n<li><b>Safety<br \/>\n<\/b>Both predictable and difficult-to-predict cases were observed with respect to the risk of treatment-related adverse events (TRAEs) such as severe bleeding, airway obstruction and fistula, or functional loss. These findings underscore the importance of careful treatment planning, including thorough assessment of the relationship between the tumor and surrounding anatomical structures, to minimize the risk of such events. Furthermore, because pre-treatment imaging alone may not predict severe TRAEs in all cases, thorough assessment and appropriate patient risk communication are also essential.<\/li>\n<\/ul>\n<p>*<em>Tumor response<\/em> refers to the lesion-based response (Complete response: CR, partial response: PR, stable disease: SD, and progressive disease: PD).<\/p>\n<p><b>Background<\/b><\/p>\n<p><span style=\"font-weight: 400\">Photoimmunotherapy using ASP-1929 (cetuximab sarotalocan sodium) is a drug\u2013device combination therapy targeting epidermal growth factor receptor (EGFR)-expressing tumor cells, activated by localized illumination with 690 nm red light.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Clinical studies<\/span><sup>1,2<\/sup><span style=\"font-weight: 400\"> of ASP-1929 PIT in head and neck cancer have shown meaningful antitumor activity and a manageable safety profile. In Japan, the drug, Akalux\u2122 (ASP-1929) and medical device, BioBlade\u2122 Laser System for the treatment of unresectable locally advanced or recurrent head and neck cancer were approved in 2020.\u00a0 Outside of Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority.<\/span><\/p>\n<p><span style=\"font-weight: 400\">In ASP-1929-401 study, primary endpoint results showed an overall response rate (ORR) of\u00a0 60.8% and a disease control rate (DCR) of 95.9% per laser-illuminated lesion<\/span><sup>3<\/sup><span style=\"font-weight: 400\">. Additionally, results from a secondary endpoint indicated a safety profile consistent with previous studies<\/span><sup>3<\/sup><span style=\"font-weight: 400\">.<\/span><\/p>\n<p><span style=\"font-weight: 400\">As a key exploratory endpoint, the study evaluated the impact of PIT procedures on effectiveness and safety, including the association between complete tumor coverage and effectiveness under two effective illumination range assumptions, and whether pre-treatment imaging could predict the risk of serious TRAEs and functional impairments.<\/span><\/p>\n<p><b>Study Overview<\/b><\/p>\n<p><span style=\"font-weight: 400\">ASP-1929-401 is an open-label observational study enrolled 77 patients from 24 centers between January 2021 and September 2022.<\/span><span style=\"font-weight: 400\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">Endpoints:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Primary endpoint: Antitumor effect per laser-illuminated lesion, measured by tumor volume reduction rate<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Key secondary endpoint: Incidence of treatment-related adverse events<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Key exploratory endpoint: Impact of PIT procedures on effectiveness and safety<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400\">Data Review Board evaluated tumor coverage based on the effective illumination range and risks of interest under outcome-blinded assessment.<\/span><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-8004-1\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-8004-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-8004-1-0-0\" 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-8004-1-0-0\" ><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><b>About ASP-1929<\/b><\/p>\n<p><span style=\"font-weight: 400\">Rakuten Medical\u2019s first pipeline drug developed on its Alluminox\u00ae 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.<\/span><\/p>\n<p><b>About Alluminox\u00ae platform\u00a0<\/b><span style=\"font-weight: 400\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">The Alluminox\u00ae platform is a 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 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 team from 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 Rakuten Medical, Inc.\u00a0<\/b><\/p>\n<p><span style=\"font-weight: 400\">Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell-targeting Alluminox\u00ae 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>Forward Looking Statements\u00a0<\/b><span style=\"font-weight: 400\">\u00a0<\/span><\/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\u00ae 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><b>References:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Cognetti DM et al. Head Neck. 2021;43:3875\u201387<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Tahara M et al. Int J Clin Oncol. 2021;26:1812\u201321<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Shinozaki T et al. Lesion-Based Analysis of Efficacy and Safety in a Multicenter Observational Study of Photoimmunotherapy for Head and Neck Cancer. The 34th Annual Meeting of the Japan Society for Head and Neck Surgery, Tokyo, Japan, Jan 2025<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Media &amp; Investor Contact:<\/strong><\/p>\n<p>Abhijit Bhatia, Chief Operating Officer<\/p>\n<p>Tel: +1-619-650-1549 | Email: <a href=\"mailto:abhijit.bhatia@rakuten-med.com\">abhijit.bhatia@rakuten-med.com<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>Ai Yoshikawa, Associate Director, Global Corporate Communications &amp; Investor Relations<\/p>\n<p>Tel: +81-(0)70-4196-0845 | Email: <a href=\"mailto:ai.yoshikawa@rakuten-med.com\">ai.yoshikawa@rakuten-med.com<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><div id=\"pg-8004-2\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-8004-2-0\"  class=\"panel-grid-cell\" ><div id=\"panel-8004-2-0-0\" class=\"so-panel widget widget_sow-button panel-first-child panel-last-child\" data-index=\"4\" ><div style=\"padding: 30px 0px 0px 0px;\" class=\"panel-widget-style panel-widget-style-for-8004-2-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-button so-widget-sow-button-flat-6fd36f18507f-8004\"\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>\u2014 Real-World Evidence Evaluating the Association Between Treatment Procedures and Effectiveness and Safety \u2014 Disclaimer: Rakuten Medical\u2019s Alluminox\u00ae platform-based photoimmunotherapy [&hellip;]<\/p>\n","protected":false},"author":2,"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":["post-8004","press_releases","type-press_releases","status-publish","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - 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