– Poster will highlight interim evaluation update of photoimmunotherapy based on Alluminox™ platform using ASP-1929 in combination with anti-PD-1
– Japanese treating physicians will present a poster on the latest data on photoimmunotherapy in clinical practice in Japan for recurrent nasopharyngeal carcinoma

Disclaimer: Rakuten Medical’s therapies based on Alluminox™ platform are investigational outside of Japan.

SAN DIEGO, May 9, 2024 /PRNewswire/ — Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary Alluminox™ platform, today announced that it will present a poster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (ASCO 2024), which will be held in Chicago, Illinois from May 31 through June 4, 2024.

The poster presentation will showcase the updated safety and efficacy findings from an interim evaluation of Rakuten Medical’s open-label Phase 1b/2 study (ASP-1929-181/ClinicalTrials.gov Identifier: NCT04305795) of photoimmunotherapy using ASP-1929 in combination with anti-PD-1 therapy in recurrent or metastatic head and neck squamous cell carcinoma.

Rakuten Medical will also have a booth in the Exhibit Hall. The Company medical team will be pleased to welcome ASCO participants at booth #12118.

Rakuten Medical’s Poster Presentation

Abstract Title: Recent safety and efficacy findings from a phase 1b/2 open-label combination study of ASP-1929 photoimmunotherapy with anti-PD-1 therapy in EGFR-expressing advanced head and neck squamous cell carcinoma (HNSCC)
Abstract Number: 6083
Abstract Link: https://meetings.asco.org/abstracts-presentations/234832
Session Name: Poster Session – Head and Neck Cancer
Session Date: Sunday, June 2, 2024
Session Time: 9:00 a.m. – 12:00 p.m., CDT
First Author: David M. Cognetti, Department of Otolaryngology – Head and Neck Surgery, Thomas Jefferson University, US
Location: Exhibit Hall A, Poster Board #399

Rakuten Medical Booth

Location: Exhibit Hall A, Booth #12118
Exhibit Date: Saturday – Monday, June 1 – 3, 2024

In addition, a research team of Japanese physicians will present a poster on the latest findings from a multi-institutional observation study evaluating the efficacy and safety of photoimmunotherapy for recurrent nasopharyngeal cancer in clinical practice in Japan.

Poster Presentation by Japanese Physicians

Abstract Title: Photoimmunotherapy in nasopharyngeal carcinoma recurrence
Abstract Number: 6068
Abstract Link: https://meetings.asco.org/abstracts-presentations/234781
Session Name: Poster Session – Head and Neck Cancer
Session Date: Sunday, June 2, 2024
Session Time: 9:00 a.m. – 12:00 p.m., CDT
First Author: Takeshi Shinozaki, Department of Head and Neck Surgery, National Cancer Center Hospital East, Japan
Location: Exhibit Hall A, Poster Board #384

The full abstracts will be available on the ASCO Annual Meeting website.

For more information and update, follow Rakuten Medical on LinkedIn or visit Rakuten Medical’s booth at ASCO 2024.

About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, which, in pre-clinical studies, has 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 its innovative 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 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 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, 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. 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.

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