Rakuten Medical Selected to Participate in FDA CEO Forum in San Diego

- Engaged with FDA Commissioner on shared commitment to fast, safe, and affordable patient access to innovative therapies

SAN DIEGO, June 13, 2025 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, today announced that it was selected by the U.S. Food and Drug Administration (FDA) to participate in the FDA CEO Forum in San Diego, California, on June 13, 2025. Minami Maeda, President of Rakuten Medical, attended the meeting in person as a member of this panel, to discuss with FDA Commissioner Marty A. Makary, M.D., M.P.H., and other industry leaders how the FDA can "modernize its regulatory framework to better support innovation and patient access to safe and effective therapies".

Rakuten Medical – whose innovative cancer therapeutic technology, the Alluminox™ platform, is in Phase 3 trials in the U. S. – was selected to join the forum as one of the companies at the front lines of medical discovery. Rakuten Medical's novel treatment modality, known as photoimmunotherapy, is designed to induce rapid and selective depletion of cancer or immunosuppressive cells with minimal impact on surrounding healthy tissue. Moreover, pre-clinical observation have shown that photoimmunotherapy may also stimulate both innate and adaptive anti-tumor immune responses.

"Rakuten Medical's Alluminox™ platform has the potential to transform cancer therapy in the U.S.," said Maeda. "We are honored to be recognized by the FDA and invited to contribute to discussions on how regulatory innovation can accelerate the delivery of pioneering treatments to patients. We fully support the FDA's vision of a modern framework that ensures timely access, safety, and affordability."

Rakuten Medical is currently conducting a global Phase 3 clinical trial evaluating its ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 / Acronym: ECLIPSE / ClinicalTrials.gov Identifier: NCT06699212). A prior Phase 1b/2 study showed promising interim evaluation results, including a 24-month survival rate of 52.4% and a median overall survival (OS) not yet reached. ASP-1929 photoimmunotherapy received the world's first regulatory approval in Japan under the Conditional Early Approval System based on a certain level of efficacy and acceptable safety from Phase 1/2a trial results. It is being delivered to patients in Japan at an affordable price.

Disclaimer: Rakuten Medical's Alluminox™ platform-based photoimmunotherapy is investigational outside Japan.

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.

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-EGFR antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptor (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.

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SOURCE Rakuten Medical, Inc.