Rakuten Medical Completes Technology Transfer of IR700 Manufacturing and Establishes Exclusive Position in its Supply

• IR700, a light-activatable dye, is a key component of the Alluminox™ platform-based photoimmunotherapy
• IR700 is being investigated in several other therapeutic modalities targeting diseases such as ocular melanoma and bladder cancer
• Rakuten Medical strengthens its technology platform and business foundation through a robust IP & product portfolio strategy
• Through strategic alliances for its supply, Rakuten Medical aims to make greater impact on patients' lives

SAN DIEGO, Feb. 4, 2025 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting Alluminox™ platform-based photoimmunotherapy, today announced that it has completed the transfer of manufacturing technology from LI-COR Biosciences (LI-COR) for IRDye^® 700DX (IR700), a light-activatable dye. IR700 is a pivotal component of the Alluminox™ platform.

Rakuten Medical is currently developing drug conjugates using IR700 and cell-targeting moieties. IR700 is activated by direct illumination with 690 nm light to selectively disrupt targeted cell membranes. The Company acquired the intellectual property, manufacturing technology, marketing rights, and all associated data for IR700 from LI-COR in December 2020. With the successful completion of the technology transfer, Rakuten Medical now serves as the sole owner and exclusive manufacturer & supplier of IR700. Through its capabilities for in-house production and supply, Rakuten Medical stands ready to strategically partner with companies, universities, and research institutions that are utilizing it in their therapeutic modalities.

IR700, a dye derived from phthalocyanine, is distinguished by its hydrophilic structure, low toxicity, and light activation properties at a wavelength of 690 nm ¹. Since light at approximately 690 nm can penetrate tissues to a certain depth, IR700 is suitable for various light-based therapies, including photoimmunotherapy. Its applications range from basic research in academia to clinical trials by biotech companies, including late-stage pipelines for various diseases such as ocular melanoma and bladder cancer. However, the complex and sensitive nature of IR700's structure requires strict control over its synthesis, mass production, conjugation manufacturing, and rigorous quality assurance process.

Mickey Mikitani, Chief Executive Officer and Vice Chairman of the Board of Rakuten Medical, commented, "IR700 is a unique, high-potential asset, playing a vital role in the Alluminox™ platform-based photoimmunotherapy and other therapeutic technologies. By achieving complete in-house manufacturing and exclusive supply of IR700, we have further enhanced both our technology platform and business foundation. Moving forward, we will strategically pursue partnerships with organizations that align with our values to drive the advancement of IR700-related therapeutic technologies, extending beyond the Alluminox™ platform and potentially contributing to the treatment of a broader range of patients worldwide."

Disclaimer: Rakuten Medical's Alluminox™ platform-based photoimmunotherapy is investigational outside Japan.

1. Mitsunaga, Makoto et al. "Cancer cell-selective in vivo near infrared photoimmunotherapy targeting specific membrane molecules." Nature medicine vol. 17,12 1685-91. 6 Nov. 2011, doi:10.1038/nm.2554

About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ 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 delivering its innovative 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 an investigational technology platform based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and team from the National Cancer Institute in 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. The device component consists of a light source that locally illuminates the targeted cells with light to transiently activate the drug. 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 Japan, Alluminox therapies have not yet been approved by any regulatory authority.

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.

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