Disclaimer: Rakuten Medical’s therapies based on Alluminox™ platform are investigational outside of Japan.
Rakuten Medical held its second R&D Day on August 10, 2023, for an audience limited to pre-registered attendees from around the world. During the virtual event, special guest speaker, Ann M. Gillenwater, MD, Professor, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center presented the preliminary safety and efficacy results from ASP-1929-181, a Phase 1b/2, open-label study of Alluminox treatment (photoimmunotherapy) using ASP-1929 in combination with anti-PD-1 therapy for recurrent and/or metastatic head and neck cancer. For more information on the data, please see the replay at the end of this article or the press release.
Dr. Gillenwater showcased how encouraging the preliminary ASP-1929-181 data was by stating:
“This is a novel approach that can be used after patients have already received standard therapies of surgery and radiation. The combination of the anti-PD-1 therapy with the photoimmunotherapy showed very promising early results and it was generally tolerated with manageable treatment-related adverse events.” 1.
1. These preliminary findings may change upon completion of follow up and final data analysis.
Rakuten Medical’s management team shared numerous business updates which include the recently announced licensing agreement with Hikma Pharmaceuticals for MENA region, a Japan commercial update, the Global Phase 3 Trial of ASP-1929 in India (ASP-1929-301 / ClinicalTrials.gov Identifier: NCT03769506 / CTRI Identifier: CTRI/2023/05/052728), and the new study of its second asset RM-1995 in Japan (RM-1995-102 / jRCT number: 2031220721).
Takashi Toraishi, Co-CEO and President of Rakuten Medical described the potential of its proprietary technology platform as:
“Our technology will generate rapid cell killing with minimal effects on surrounding tissues (based on preclinical observations). We believe that Alluminox™ platform will change the paradigm of the cancer treatment as a potential fifth pillar.”
Abhijit Bhatia, Chief Operating Officer of Rakuten Medical overviewed the company’s growth by sharing updates on Rakuten Medical’s commercial, clinical and business progress and commented:
“We have been co-creating innovation with excellent partners with the goal of bringing our technology to patients globally. We’re conducting clinical trials at top institutes throughout the world. In Japan, we have a strong track record, supported by partner hospitals, providing more than 330 treatments as of August 2023.” 2
2. Rakuten Medical’s therapies based on Alluminox™ platform are investigational outside of Japan.
Toshiaki Suzuki, Co-Chief Medical Officer of Alluminox Treatment at Rakuten Medical highlighted the Company’s collaboration with physicians in delivering Rakuten Medical’s Alluminox treatment to patients in Japan safely and effectively.
“Working closely with medical experts and societies in Japan, we created the Alluminox Certification System and Alluminox Training Program. We’ve also created an AE management handbook, which is important to understand how to manage adverse event.”
If you would like to view a complete replay of our second R&D Day, please click the link below to register and reach out to us for password: https://lifescievents.com/event/rakuten/
Forward Looking Statements
This article contains “forward looking” statements as defined under the (United States) 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.