Rakuten Medical to Host Research & Development Day on Investigational Alluminox™ Platform

Key Opinion Leader in Head and Neck Cancer Introduces the Potential of Rakuten Medical's Photoimmunotherapy-based Oncology Technology

SAN DIEGO, March 1, 2023 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing precision, cell-targeting therapies based on its proprietary photoimmunotherapy technology Alluminox™ platform, today announced that it will host a Research & Development Day on Thursday, March 16, 2023 from 12:30 p.m. – 2:00 p.m. ET / 9:30 a.m. – 11:00 a.m. PT.  This virtually held event will showcase the possibilities of Rakuten Medical's oncology technology and its lead investigational compound ASP-1929.

The Alluminox platform – using the power of light with drug and device components – has been observed in pre-clinical trials to target specific tumors as well as immunosuppressive cells for destruction with minimal effects on surrounding normal tissue.  ASP-1929, based on the platform, is approved in Japan and has been marketed as Akalux® since January 2021 and is currently the subject of a global Phase 3 clinical trial evaluating the efficacy and safety of the compound for recurrent head and neck cancer. ASP-1929 is also being evaluated in clinical trials in combination with other local and systemic anti-cancer modalities.  For more details, please see our pipeline on our website.  ASP-1929 has not been approved for use by any regulatory authority outside of Japan.

The event will feature David M. Cognetti, MD in Thomas Jefferson University and Sidney Kimmel Cancer Center who will discuss the development of ASP-1929 in the United States.  Rakuten Medical's management team will also share their most updated pipeline status and further geographic and indicational expansion.

Parties interested in participating in this event should click here to register and access the live webcast.  Please note that practicing healthcare professionals and patients are not permitted to attend.

About Rakuten Medical, Inc. 
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 drug developed on the Alluminox platform, ASP-1929, has received approval 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. The company has offices in 6 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, India, and Switzerland. For more information, visit www.rakuten-med.com.

About Alluminox™ platform 
The Alluminox™ 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 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 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 Alluminox 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 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. 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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SOURCE Rakuten Medical, Inc.