Rakuten Medical is developing innovative photoimmunotherapy treatments based on its proprietary Alluminox™ platform for patients around the world. Therapies developed based on the platform are what Rakuten Medical refers to as Alluminox treatments.
Alluminox treatments consist of a drug-device combination and involve a two-step process: 1) drug administration and 2) local illumination with red light (690nm) to activate the drug component. The drug component consists of a cell-targeting moiety conjugated to a photoactivatable dye (IRDye® 700DX [IR700]) that selectively binds the surface of target cells, such as tumor cells.
Rakuten Medical is developing drugs using a variety of cell-targeting moieties including antibodies, in its drug discovery program, Alluminox Palette™. ASP-1929 (Japanese brand name: Akalux® 250 mg for intravenous infusion) received marketing approval for unresectable locally advanced or recurrent head and neck cancer in Japan.
The pipeline for Alluminox treatments using these drug candidates is as follows.
As of December 2023
Locoregional, recurrent head and neck squamous cell carcinoma
Unresectable locally advanced or recurrent head and neck cancer (after 4th treatment cycle)
(Post-marketing clinical trial) 1
Operable primary or recurrent head and neck or cutaneous squamous cell carcinoma
(Window of Opportunity study)
ASP-1929 + Anti-PD-1 Combination Therapy
Recurrent or metastatic head and neck squamous cell carcinoma or locally advanced or metastatic cutaneous squamous cell carcinoma
Locoregional recurrent head and neck squamous cell carcinoma
Unresectable advanced or recurrent esophageal cancer or gastric cancer
Advanced or recurrent solid tumors with liver metastases
- ASP-1929-402 study is being conducted as a post-marketing clinical trial of ASP-1929 (Japanese brand name: Akalux® 250 mg for intravenous infusion). ASP-1929 was approved in Japan based on RM-1929-101 study (ClinicalTrials.gov: NCT02422979) and RM-1929-102 study (jRCT: jRCT2031200133). RM-1929 and ASP-1929 are analogous and have comparable physical and chemical properties.
- ASP-1929-103 study is being conducted in collaboration with the National Cancer Institute at the National Institutes of Health and Shimadzu Corporation. A Window of Opportunity study takes place in the period between a cancer diagnosis and the subsequent initiation of standard treatment, during which, the patient receives a non-standard drug or treatment of interest over a short period of time.ⅰ ⅱ
- Aroldi F, Lord SR. Window of opportunity clinical trial designs to study cancer metabolism. Br J Cancer. 2020;122(1):45-51. doi:10.1038/s41416-019-0621-4
- Schmitz S, Duhoux F, Machiels JP. Window of opportunity studies: Do they fulfil our expectations? Cancer Treat Rev. 2016 Feb;43:50-7. doi: 10.1016/j.ctrv.2015.12.005. Epub 2015 Dec 31. PMID: 26827692.
- Currently not recruiting
- Completed study
- This study is part of a research and development project adopted by the Japan Agency for Medical Research and Development (AMED) and funded by AMED.
This pipeline chart represents a selection of Rakuten Medical’s developmental product candidates and is designed to demonstrate our commitment to patients as we strive to accomplish our corporate mission to conquer cancer. Rakuten Medical’s pipeline will change over time as products move through the development process, including, as applicable, progressing through clinical phases to licensure, engaging in partnerships, in-licensing and out-licensing, or failing in clinical trials to demonstrate efficacy, safety or to deliver a commercially viable product, all due to the nature of the drug and device development processes. This description contains forward-looking statements that involve significant risks and uncertainties, and actual results may vary materially. Unless otherwise noted, Rakuten Medical provides this information as of December 2023, and Rakuten Medical expressly disclaims any duty to update any of the provided information or forward-looking statements contained in this table as a result of new information, future events, or otherwise.