Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting investigational therapies on its Alluminox™ platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Alluminox therapies have not yet been approved as safe or effective by any regulatory authority. The company’s first investigational drug developed on the Alluminox™ 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 by delivering our innovative treatments as quickly and safely as possible to as many patients all over the world as possible.
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ASP-1929: Since 2013, Rakuten Medical, Inc. has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Alluminox™ technology platform. Rakuten Medical’s first pipeline drug developed using its Alluminox platform is ASP-1929, an antibody-dye conjugate comprised of the antibody cetuximab and IRDye® 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, cutaneous, esophageal, lung, colon and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination emitted by a laser device system. Pre-clinical data indicates that Alluminox technology induces a biophysical process that compromises cell membrane integrity, leading to cancer cell death and tumor necrosis. ASP-1929 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 and the laser device system have not yet been approved by any regulatory authority.
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