Rakuten Medical to Host Virtual R&D Day on Thursday, August 10, 2023

• Dr. Gillenwater will discuss the promising data of Alluminox treatment using ASP-1929 in combination with anti-PD-1 therapy
• Rakuten Medical's management team will provide recent business updates

SAN DIEGO, July 18, 2023 /PRNewswire/ -- Rakuten Medical, Inc. (Rakuten Medical), a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy-based on its proprietary Alluminox™ platform, today announced it will host a virtual R&D Day on the preliminary safety and efficacy findings from its open-label Phase 1b/2 study of Alluminox™ treatment using ASP-1929 in combination with anti-PD-1 therapy in recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). The webinar will take place on Thursday, August 10, 2023 at 8:30 AM PT / 11:30 AM ET.

The event will feature Ann M. Gillenwater, Professor, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center who will discuss the promising results of the novel combination and the potential implications for the current treatment landscape. Rakuten Medical's management team will provide other business updates including, but not limited to, a Japan commercial update and the Global Phase 3 Trial of ASP-1929 in India.

Rakuten Medical's technology consists of drug and device components and which Rakuten Medical hopes will become a potential 5^th pillar of cancer treatment. The Alluminox™ platform has been shown in pre-clinical trials to target specific tumors as well as immunosuppressive cells for destruction with minimal effects on surrounding normal tissue.

ASP-1929 targeting EGFR is approved in Japan and has been marketed as Akalux® since January 2021 for unresectable locally advanced or recurrent head and neck cancer. ASP-1929 received Fast Track designation from the U.S. FDA in January 2018, and is currently under investigation in a global Phase 3 clinical trial for recurrent head and neck cancer but outside of Japan, ASP-1929 has not yet been approved by any regulatory authority.

A live question and answer session will follow the formal presentation. 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 Ann M. Gillenwater, M.D.

Ann Gillenwater, MD is a Professor of Head & Neck Surgery and Director of the Oral Cancer Prevention Center at the University of Texas MD Anderson Cancer Center in Houston, Texas, USA.  She evaluates and treats a large number of patients with oral premalignant lesions and oral cancers. An NIH funded investigator, her research interests focus on development of new technologies for detection and diagnosis of early oral cancer and precancer. She is also actively researching identification of biomarkers for identification of patients at high risk for oral cancer development and/or progression.

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 our innovative treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 6 countries, including the United States, where it is headquartered, Japan, the Netherlands, 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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SOURCE Rakuten Medical, Inc.