- First presentation of results from a global Phase 3 study of ASP-1929 photoimmunotherapy as monotherapy in locoregional recurrent head and neck squamous cell carcinomas (HNSCC)
- Real‑world Japanese multicenter data on photoimmunotherapy in recurrent nasopharyngeal carcinoma
Disclaimer: Rakuten Medical’s Alluminox® platform-based photoimmunotherapy is investigational outside Japan.
SAN DIEGO — April 30, 2026 — Rakuten Medical, Inc., a global biotechnology company developing and commercializing the Alluminox platform-based photoimmunotherapy, today announced that two abstracts have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from May 29 - June 2, 2026.
One poster will feature the first presentation of safety and efficacy data from Rakuten Medical’s global Phase 3, randomized, double-arm, open-label, controlled study (ASP-1929-301; NCT03769506) evaluating ASP-1929 photoimmunotherapy for locoregional, recurrent HNSCC. This ASP-1929-301 study was conducted at 40 facilities across the U.S., Taiwan, Japan, India, and Ukraine.
Another poster, authored by a research team of Japanese physicians, will present the latest findings from an investigator-initiated multicenter observational study evaluating the efficacy and safety of photoimmunotherapy for recurrent nasopharyngeal cancer in clinical practice in Japan.
Rakuten Medical will also have a booth in the Exhibit Hall. The Company medical team will be pleased to welcome ASCO participants at booth #37147.
Poster Presentation for ASP-1929-301 Study:
- Abstract Title: A phase 3, randomized, double-arm, open-label, controlled study of ASP-1929 photoimmunotherapy (PIT) versus physician’s choice standard of care (SOC) for patients with locoregional, recurrent head and neck squamous cell carcinoma (HNSCC)
- Abstract Number: 6080
- Abstract Link: https://www.asco.org/abstracts-presentations/261461
- Session Name: Poster Session – Head and Neck Cancer
- Session Date: Saturday, May 30, 2026
- Session Time: 1:30 p.m. – 4:30 p.m., CDT
- First Author: Anastasios Maniakas, Assistant Professor of Head and Neck Surgery at The University of Texas MD Anderson Cancer Center
- Location: Exhibit Hall A, Poster Board #537
Poster Presentation for Real‑World Japanese Multicenter Data:
- Abstract Title: Real-world efficacy and safety of photoimmunotherapy for recurrent nasopharyngeal carcinoma: A nationwide multicenter study in Japan
- Abstract Number: 6030
- Abstract Link: https://www.asco.org/abstracts-presentations/263351
- Session Name: Poster Session – Head and Neck Cancer
- Session Date: Saturday, May 30, 2026
- Session Time: 1:30 p.m. – 4:30 p.m., CDT
- First Author: Hideki Tanaka, Department of Otolaryngology, Head and Neck Surgery, Tokyo Medical University
- Location: Exhibit Hall A, Poster Board #384
Rakuten Medical Booth:
- Location: Exhibit Hall A, Booth #37147
- Exhibit Dates: Saturday – Monday, May 30 - June 1, 2026
For more information and updates, please follow Rakuten Medical on LinkedIn or visit Rakuten Medical’s booth at ASCO 2026.
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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