As Rakuten Medical enters its next phase of growth, this leadership transition reflects the company's ongoing evolution and commitment to its corporate mission of "Conquering Cancer." The move aims to accelerate decision-making and strengthen disciplined execution across the organization.
As Executive Chairman, Mickey will continue to provide strategic direction and long-term vision while remaining deeply committed to the company's mission, supporting long-term growth initiatives.
As the full-time, dedicated CEO, Minami will work closely with the global team to drive agile decision-making, while strengthening organizational resilience and execution in preparation for upcoming regulatory approval and commercial launch in the United States and other markets.
Rakuten Medical is accelerating its global Phase 3 clinical trial (ASP-1929-381, NCT06699212) to support its top priority of submitting a Biologics License Application (BLA) to the U.S. FDA in 2028. The ASP-1929-381 trial evaluates ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for recurrent head and neck cancer. Patient enrollment is progressing ahead of plan, across the United States, Taiwan, Japan, and Ukraine.
In parallel, the company is advancing efforts to secure approvals in additional markets, in collaboration with regional strategic partners, by leveraging clinical data package and post-marketing real-world data from Japan for its approved drug Akalux™ (ASP-1929) and medical device BioBlade™ Laser System for the treatment of unresectable locally advanced or recurrent head and neck cancer.
Disclaimer: Rakuten Medical's Alluminox® platform-based photoimmunotherapy is investigational outside Japan.
To broaden its clinical scope, Rakuten Medical is advancing development beyond head and neck cancer. With support from external grants, multiple programs are underway to evaluate the potential of the Alluminox platform across diverse tumor types. These efforts are further supported by the continued adoption of its treatment in Japan.
"I first encountered photoimmunotherapy when my father was diagnosed with cancer. It has been a source of pride in my career as an entrepreneur to support the development of Alluminox platform-based photoimmunotherapy over the past 13 years—as a family member of a patient, an investor, and as CEO. At the same time, the development of the Alluminox platform has only just begun. We must continue to grow as a company so that we can bring this innovation to patients around the world," said Mickey Mikitani, the current CEO and Vice Chairman of the Board of Rakuten Medical. "Since joining the company in 2017, Minami Maeda has demonstrated strong leadership, strategic insight and execution capabilities, contributing significantly to Rakuten Medical's growth and expanding patient access to our therapy. I have complete confidence in his leadership and look forward to supporting him and the company in my new role as Executive Chairman."
Minami Maeda, currently serving as President of Rakuten Medical, commented, "I am honored to take on the role of CEO at this important stage in Rakuten Medical's growth. Over the past several years, our team has achieved significant progress across clinical development, global expansion, and commercialization in Japan, demonstrating strong resilience and commitment to our mission. As we now enter a critical phase, our focus is on delivering against key priorities, including advancing the ASP-1929-381 trial, preparing for regulatory milestones and expanding our commercial footprint. Together with Mickey Mikitani and our global team, we will continue to strengthen our execution and organizational focus, while working to deliver innovative treatment options to patients worldwide in support of our mission."
About Alluminox® platform
The Alluminox platform is Rakuten Medical's investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical's 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 tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational.
About ASP-1929
Rakuten Medical's first pipeline drug developed on its Alluminox® platform is ASP-1929, an antibody-dye conjugate comprised of the anti-epidermal growth factor receptor (EGFR) antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 binds to EGFR, a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority.
About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox® platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.
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