Rakuten Medical Announces Trial in Progress Poster Presentation at ASCO 2025 and Enrollment Expansion to Taiwan for Global Phase 3 ASP-1929-381

• Poster presentation to highlight the ongoing global Phase 3 ASP-1929-381 study at ASCO 2025
• Global patient enrollment continues, with Taiwan now actively enrolling following the U.S., and Japan expected to follow as part of global study start-up

SAN DIEGO, May 22, 2025 -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, today announced that it will present a Trial in Progress poster at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place May 30 – June 3, 2025, in Chicago, Illinois.

The poster will feature Rakuten Medical's ongoing global Phase 3 clinical trial evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab (anti-PD-1) as a first-line therapy for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 / Acronym: ECLIPSE / ClinicalTrials.gov Identifier: NCT06699212). The poster will also highlight interim findings from the completed Phase 1b/2 study (ASP-1929-181 / ClinicalTrials.gov Identifier: NCT04305795) which evaluated ASP-1929 photoimmunotherapy in combination with anti-PD-1 in recurrent or metastatic HNSCC.

"We are honored that our Trial in Progress poster has been accepted for presentation at ASCO 2025," said Anastasios Maniakas, MD, PhD, Assistant Professor in the Department of Head and Neck Surgery and an investigator of the ASP-1929-381 study at The University of Texas MD Anderson Cancer Center. "This Phase 3 study represents a significant step forward in evaluating the potential synergistic efficacy of ASP-1929 photoimmunotherapy and pembrolizumab as a first-line treatment for patients with recurrent HNSCC. We look forward to sharing our progress with the global oncology community and advancing innovative approaches for the treatment of patients facing this challenging disease."

Rakuten Medical is also pleased to announce that it has recently initiated patient enrollment in Taiwan as part of its global expansion of the Phase 3 ASP-1929-381 study. Currently, over 10 clinical sites across the United States and Taiwan are actively enrolling patients. Additional sites are expected to be activated in both regions, with patient enrollment in Japan anticipated to begin shortly.

"We are pleased to be part of this global Phase 3 study and to contribute to the development of an innovative treatment approach like photoimmunotherapy," said Kai-Ping Chang, MD, PhD, Professor of the Department of Otolaryngology - Head & Neck Surgery and Principal Investigator of the ASP-1929-381 study at Chang Gung Memorial Hospital in Taiwan. "Head and neck cancer ranks third in male cancer incidence and fourth in male cancer mortality in Taiwan¹. Local recurrence or metastasis is one of the leading causes of death in these patients², and nearly half of those with recurrent or metastatic disease survive for less than one year³. By participating in this trial, we hope to help advance new therapeutic options that may prolong overall survival of patients with recurrent HNSCC, both in Taiwan and around the world."

ASCO attendees are invited to visit Rakuten Medical at booth #33110 to learn more about the ASP-1929-381 study and the company's broader Alluminox™ platform.

Rakuten Medical's Trial in Progress Poster Overview

• Abstract Title: A phase 3 randomized study of ASP-1929 photoimmunotherapy in combination with pembrolizumab versus standard of care in locoregional recurrent head and neck squamous cell carcinoma (HNSCC)
• Abstract Number: TPS6122
• Abstract Link: https://meetings.asco.org/abstracts-presentations/253337
• Session: Poster Session – Head and Neck Cancer
• Date: Monday, June 2, 2025
• Time: 9:00 a.m. – 12:00 p.m., CDT
• First Author: Anastasios Maniakas, The University of Texas MD Anderson Cancer Center, TX, the U.S.
• Location: Exhibit Hall A, Poster Board # 523b

Rakuten Medical Exhibit Booth

• Location: Exhibit Hall A, Booth #33110
• Exhibit Date: Saturday – Monday, May 31 – June 2, 2025

About ASP-1929-381 Study
The ASP-1929-381 study is a multi-regional multi-center, randomized, open-label Phase 3 trial, designed to assess the efficacy and safety of ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC without distant metastases. 412 patients globally will be randomized to either an experimental arm receiving ASP-1929 photoimmunotherapy in combination with pembrolizumab, or a control arm receiving the current pembrolizumab-based standard of care (SOC), where patients may receive pembrolizumab alone or in combination with chemotherapy according to the physician's choice.
The primary endpoint is Overall Survival (OS), with key secondary endpoints including Complete Response Rate (CRR) and Overall Response Rate (ORR).

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

1. 111^th Taiwan Cancer Registry Report, National Health Service, Ministry of Health and Welfare
2. A Novel CXCR4-Targeted Diphtheria Toxin Nanoparticle Inhibits Invasion and Metastatic Dissemination in a Head and Neck Squamous Cell Carcinoma Mouse Model. Pharmaceutics. 2022 Apr 18;14(4):887. doi:10.3390/pharmaceutics14040887
3. Argiris A, Harrington KJ, Tahara M, Schulten J, Chomette P, Ferreira Castro A, Licitra L. Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck. Front Oncol. 2017 May 9;7:72. doi: 10.3389/fonc.2017.00072.

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.

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