Rakuten Medical to Present New Data of Alluminox™ Treatment using ASP-1929 in Combination with anti-PD-1 at AHNS 2023

SAN DIEGO, May 12, 2023 /PRNewswire/ -- Rakuten Medical, Inc. (Rakuten Medical), a global biotechnology company developing and commercializing precision, cell-targeting therapies based on its proprietary Alluminox™ platform, today announced that the abstract 'Safety and efficacy findings from a phase 1b/2 open-label study of a novel combination of ASP-1929 photoimmunotherapy with anti-PD-1 therapy in EGFR-expressing advanced head and neck squamous cell carcinoma' has been selected for a podium presentation at this year's American Head and Neck Society (AHNS) 11^th International Conference on Head and Neck Cancer (AHNS 2023). AHNS is the single largest organization in North America for the advancement of research and education in head and neck oncology. AHNS 2023 will be held from July 8^th to 12^th, 2023 in Montreal, Canada.

The presentation will for the first time showcase topline safety and efficacy findings from an open-label Phase 1b/2 study (ASP-1929-181/ClinicalTrials.gov Identifier: NCT04305795) of Alluminox treatment (photoimmunotherapy) using ASP-1929 in combination with anti-PD-1 therapy in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Rakuten Medical will also have a booth in the exhibit hall. In addition, several presentations involving Alluminox treatment (photoimmunotherapy) have also been selected for presentation at AHNS 2023.

Details on Rakuten Medical activities throughout AHNS 2023 are below:

Podium Presentation

• Abstract Title: Safety and efficacy findings from a phase 1b/2 open-label study of a novel combination of ASP-1929 photoimmunotherapy with anti-PD-1 therapy in EGFR-expressing advanced head and neck squamous cell carcinoma
• Session Name: Proffered Papers 21 – Immunotherapy Session 2
• Session Date: Monday, July 10^th, 2023
• Session Time: 2:00 p.m. – 3:30 p.m. (approx. 10 mis for our presentation)
• Presenter: Ann M. Gillenwater, Professor, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center
• Program Number: S252

Rakuten Medical Booth

• Location: Exhibit Hall
• Exhibit Date: Sunday - Tuesday, July 9^th - 11^th, 2023

* Rakuten Medical's therapies based on Alluminox™ platform are investigational outside of Japan.

About Rakuten Medical, Inc. 
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting investigational therapies on its Alluminox™ platform, which, in pre-clinical studies, have been shown to induce rapid and selective cell killing and tumor necrosis. Alluminox therapies have not yet been approved outside of Japan. Rakuten Medical is committed to its mission to conquer cancer by delivering our innovative treatments as quickly as possible to as many patients all over the world as possible. The company has offices in 6 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

About Alluminox™ platform  
The Alluminox™ platform is an investigational technology platform based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and team from the National Cancer Institute in the United States. Rakuten Medical is developing the Alluminox platform as a technology consisting of a drug, device, and other related components. The drug component of the platform consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding. The device component consists of a light source that locally illuminates the targeted cells with non-thermal light to transiently activate the drug. 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 cancer cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Outside of Japan, Alluminox therapies have not yet been approved by any regulatory authority.

About ASP-1929
Rakuten Medical's first pipeline drug developed on its Alluminox™ platform is ASP-1929, an antibody-dye conjugate comprised of the 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, cutaneous, esophageal, lung, colon and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination emitted by a laser device system, resulting in photochemical reaction. This is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. ASP-1929 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) in January 2018, and is currently under investigation in a global Phase 3 clinical trial for recurrent head and neck cancer. 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. Outside of Japan, ASP-1929 has not yet been approved by any regulatory authority.

SOURCE Rakuten Medical, Inc.