- AMED grant to support the clinical development of RM-0256 photoimmunotherapy for targeting malignant epithelial tumors
- Targeting PD-L1, pre-clinical observations indicate RM-0256 harnesses a triple mechanism of action, with potential applications across a broad range of solid tumors, including melanoma, ocular melanoma, urologic, and breast cancers 2
SAN DIEGO, June 4, 2025 -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, today announced that its third drug candidate, RM-0256, has been selected for funding by the Japan Agency for Medical Research and Development (AMED) under its Support Program for Orphan Drug prior to the Designation.
RM-0256 is a novel antibody conjugate composed of IRDye®700DX (IR700)—a light-activatable dye for which Rakuten Medical holds exclusive global manufacturing and supply rights—and a proprietary anti-PD-L1 monoclonal antibody. The AMED funding will support the clinical development of RM-0256 photoimmunotherapy for unresectable, advanced, or recurrent malignant epithelial tumors.
In Japan, malignant epithelial tumors affect approximately 22,000 individuals annually1. While systemic therapies, including chemotherapy and immune checkpoint inhibitors, are currently the mainstay of treatment for unresectable advanced or recurrent cases, patients who develop resistance to these treatments face limited treatment options, which underscores the urgent need for novel therapeutic approaches.
RM-0256 targets Programmed Cell Death Ligand 1 (PD-L1), a key immune checkpoint protein that allows tumors to evade immune detection by binding to PD-1 receptors on activated T cells. PD-L1 is widely expressed in various solid tumors—including melanoma, ocular melanoma, lung, urothelial, gastrointestinal, gynecological, breast, and head and neck cancers2—as well as on immunosuppressive cells within the tumor microenvironment.
Pre-clinical studies of PD-L1-targeted photoimmunotherapy have suggested three complementary mechanisms of action3:
1) Direct depletion (necrosis) of PD-L1-expressing tumor cells;
2) Activation of anti-tumor immunity through the elimination of PD-L1–expressing immunosuppressive cells;
3) Checkpoint blockade, by inhibiting PD-L1/PD-1 interaction, potentially enhancing systemic immune responses.
With the support of AMED funding, Rakuten Medical is accelerating the development of RM-0256 photoimmunotherapy as a novel, multimodal cancer therapy that may induce both local and systemic anti-tumor effects.
Disclaimer: Rakuten Medical's Alluminox™ platform-based photoimmunotherapy is investigational outside Japan.
- Cancer Incidence of Japan 2020, Cancer and Disease Control Division, Ministry of Health, Labour and Welfare https://www.mhlw.go.jp/content/10900000/001231386.pdf
- Kythreotou A, Siddique A, Mauri FA, et alPD-L1Journal of Clinical Pathology 2018;71:189-194. https://jcp.bmj.com/content/71/3/189
- Thorne A. PD-L1 photoimmunotherapy kills immunosuppressive myeloid cells to activate local and systemic antitumor immunity. Abstract Number: 30050. The 83rd Annual Meeting of the Japanese Cancer Association. September 2024. https://rakuten-med.com/us/news/press-releases/2024/09/19/7864/
About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical's 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 www.rakuten-med.com.
About Alluminox™ platform
The Alluminox™ platform is Rakuten Medical's 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® 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'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.
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