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 Rakuten Medical, Inc.( HQ:San Mateo, Calif.  Chairman and CEO: Hiroshi Mikitani hereinafter “Rakuten Medical”) and Shimadzu Corporation (HQ: Kyoto Japan President and CEO Teruhisa Ueda hereinafter “Shimadzu”) today announced a joint development and commercialization agreement to advance a medical device for use on the Illuminox™ platform. This partnership will allow for the development of a medical device using optical measurement technologies to support cancer treatment by photoimmunotherapy.

Therapies developed on the Illuminox platform involve administering a targeting moiety conjugated with one or more dyes, which is illuminated by light at a specific wavelength. Light illumination of the targeted cells transiently excites the drug, and pre-clinical data have shown this excitation elicits rapid and selective necrosis of targeted cells through a biophysical process.

Based on this agreement, both companies will use their expertise to work toward the joint development of technology that will allow visualization, measurement, and recording of the reaction of the dye to light illumination in real-time. This will allow for optimization of light irradiation depending on the tumor. Both companies will cooperate to aim for commercialization of the medical device using the technology on a worldwide basis.

Rakuten Medical is developing therapies on its Illuminox platform, an investigational treatment platform based on a cancer therapy called photoimmunotherapy developed by Dr. Kobayashi and team from the National Cancer Institute in the United States. In September 2020, Rakuten Medical announced that its wholly owned subsidiary Rakuten Medical Japan K.K. received conditional marketing approval in Japan from the Ministry of Health, Labor and Welfare for ASP-1929 Photoimmunotherapy and a laser light device to treat unresectable locally advanced or recurrent head and neck cancer, and began commercialization in January 2021. Shimadzu is focusing on creating innovative products and services, which combine analytical measurements with diagnostic imaging in the healthcare field. Utilizing its measurement technologies, Shimadzu has worked with cancer institutes in both USA and Japan for the development of photoimmunotherapy at the pre-clinical stage.  

About Rakuten Medical, Inc.

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Illuminox™ platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. With its headquarters, and research and development base in the United States, Rakuten Medical has 6 locations in 5 countries, Japan, the Netherlands, Taiwan and Switzerland. For more information, visit www.rakuten-med.com.

About Shimadzu Corporation

With “Contributing to Society through Science and Technology” as the corporate philosophy and “Realizing Our Wishes for the Well-being of Mankind and the Earth” as the management principle, Shimadzu Corporation operates in various fields such as testing and measuring instruments, medical systems, aircraft equipment, and industrial machinery and equipment. For the development of photoimmunotherapy, Shimadzu has also signed joint development agreements with the National Cancer Institute and the National Cancer Center Hospital East to advance the development of measurement technologies for photoimmunotherapy.

About Illuminox™ Platform

The Illuminox platform is an investigational 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 Illuminox 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 non-thermal 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 Illuminox may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted cells and/or the removal of immunosuppressive elements within the microenvironment. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective 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 and other application securities laws. These statements include various risks, uncertainties, and assumptions that may cause Rakuten Medical's business plans and results to differ from the Company’s current anticipated results, beliefs and expectations expressed in this press release. These "forward looking statements" include, but are not limited to, information about the potential benefits of the collaboration between Rakuten Medical and Shimadzu, the status and development of our products and therapies, including ASP-1929, potential development of new fluorescence imaging technologies for photoimmunotherapy on a worldwide basis, Rakuten Medical’s  Illuminox platform development, necessary regulatory approvals, and commercial success of the product or technology may not be achieved. Forward looking 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. 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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