Rakuten Medical’s photoimmunotherapy based on the Alluminox™ platform are investigational outside Japan. This is an abridged translation of a press release issued by Rakuten Medical K.K. on 1 Nov 2024 (JST). The original Japanese version takes precedence over this document.
Rakuten Medical K.K. is pleased to announce commercialization of the medical devices “BioBlade Laser WR” and “BioBlade SideFire Diffuser,” used for laser light illumination in photoimmunotherapy for unresectable locally advanced or locally recurrent head and neck cancer in Japan. These products were launched on 1 November 2024 in Japan as new components added to “BioBlade™ Laser System”.
Photoimmunotherapy for head and neck cancer is a treatment modality based upon its Alluminox Platform that uses a drug “Akalux™ IV Infusion 250mg” (cetuximab sarotalocan sodium) in combination with a laser device system “BioBlade Laser System”. The drug binds to epidermal growth factor receptors (EGFRs), an antigen overexpressed on the surface of cancer cells in head and neck cancer and other cancers. Illumination with laser light causes local drug activation, resulting in selective cell killing.
Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Akalux and BioBlade Laser System for “unresectable locally advanced or locally recurrent head and neck cancer” and the treatment became available to patients in January 2021. Since then approximately 700 treatments have been conducted by approximately 400 physicians at around 170 locations across Japan (as of October 2024). Rakuten Medical has developed “BioBlade Laser WR” to facilitate illumination of lesions at close range, and “BioBlade SideFire Diffuser” to enable illumination of lesions on the lumen side wall.
Rakuten Medical will continue to collaborate with healthcare professionals to further improve and develop medical devices for the advancement of photoimmunotherapy based upon its Alluminox platform, aiming to deliver it to as many head and neck cancer patients as possible.
About Akalux™ IV Infusion 250mg” (cetuximab sarotalocan sodium)
Cetuximab sarotalocan sodium is an antibody-dye conjugate comprised of the antibody cetuximab and IRDye® 700DX, a light activatable dye. This is the first drug developed on Rakuten Medical’s Alluminox™ platform.
About Alluminox™ platform
The Alluminox™ platform is a Rakuten Medical’s 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® 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’s 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’s photoimmunotherapy based on the Alluminox platform are investigational.
About Rakuten Medical K.K.
Rakuten Medical is a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary Alluminox™ platform, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical’s 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. Rakuten Medical K.K. is a subsidiary company of Rakuten Medical Inc. For more information, visit www.rakuten-med.com
Forward Looking Statements
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’s business plans and results to differ from the anticipated results and expectations expressed in these statements. These “forward looking statements” contain information about the status and development of our products, including the Alluminox™ 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 “expect,” “believe,” “hope,” “estimate,” “looks as though,” “anticipate,” “intend,” “may,” “suggest,” “plan,” “strategy,” “will,” and “do”, and are based on our current beliefs. In addition, this press release uses terms such as “important,” “notable,” and “abnormal” 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.
