Rakuten Medical Inc. is proud to announce that its wholly owned subsidiary Rakuten Medical Japan K.K. has begun commercialization of Akalux\u00ae IV Infusion (cetuximab sarotalocan sodium) and BioBlade\u00ae Laser System in Japan on January 1st, 2021 (on December 14th, 2020 for the main component of the laser).
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\nHiroshi Mikitani, Representative Director and Chairman of Rakuten Medical Japan K.K. commented, \u201cSince our approval in Japan by the Ministry of Health, Labour and Welfare last September, we have been cooperating with the related academic societies and hospitals to make progress for commercialization to deliver our treatment appropriately, as fast as possible. We feel honored to announce that we are able to deliver this treatment to patients with unresectable locally advanced or locally recurrent head and neck cancers.
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\nAbout Rakuten Medical, Inc.
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\nRakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Illuminox\u2122TM platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Illuminox\u2122 therapies have not yet been approved as safe or effective by any regulatory authority. The company\u2019s first drug developed on the Illuminox\u2122 platform, ASP-1929, has achieved Fast Track designation from the FDA and Sakigake Designation from the Japanese Ministry of Health, Labour, and Welfare, and is currently the subject of a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered 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.
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\nAbout ASP-1929
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\nSince 2013, Rakuten Medical, Inc. has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox\u2122TM technology platform. Rakuten Medical’s first pipeline drug developed on Illuminox\u2122 is ASP-1929, an antibody-drug conjugate comprised of the antibody cetuximab and IRDye\u00ae 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptors (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck cancer, esophageal cancer, lung cancer, colon cancer, and pancreatic cancer. After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination emitted by an investigational laser device system. Pre-clinical data indicate that Illuminox\u2122 technology induces a biophysical process that compromises cell membrane integrity, leading to cancer cell death and tumor necrosis. ASP-1929, has received conditional early approval from the Japanese Ministry of Health, Labor, and Welfare in September 2020, and is currently under investigation in a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical, Inc. is moving forward with product development by conducting clinical trials of monotherapy and combination therapy with other drugs. Outside of Japan, ASP-1929 has not yet been approved by any regulatory authority.
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\nAbout Illuminox\u2122 platform<\/p>\n
The Illuminox\u2122 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\u2122 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\u2122 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\u2122 therapies have not yet been approved as safe or effective by any regulatory authority.
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\nForward Looking Statements
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\nThis 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 ASP-1929, Illuminox\u2122 technology and other regulatory and marketing authorization efforts. The approval and commercial success of the product may not be achieved. Forward looking statements relate to the potential benefits, efficacy, and safety of ASP-1929, 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 ASP-1929, 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 ASP-1929, 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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\nRakuten Medical Public Relations: pr@rakuten-med.com<\/p>\n","protected":false},"excerpt":{"rendered":"
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