Pipeline
Rakuten Medical is developing Alluminox™ platform-based photoimmunotherapy for patients around the world.
Alluminox platform-based photoimmunotherapy consists of a drug-device combination and involves 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 light-activatable 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™ platform using these drug candidates is as follows.
As of February 2025
Indication
Region
Trial Name
Phase
Trial Info
ASP-1929
Locoregional, recurrent head and neck squamous cell carcinoma
Global
ASP-1929-301
Phase 3
Unresectable locally advanced or recurrent head and neck cancer (after 4th treatment cycle)
Japan
ASP-1929-402
(Post-marketing clinical trial) 1 2
Phase 4
Operable primary or recurrent head and neck or cutaneous squamous cell carcinoma
US
ASP-1929-103 2
(Window of Opportunity study)
Phase 2
Locally advanced or recurrent vulvar, vaginal, and cervical cancers
Japan
HiCARi4
(Investigator-initiated study)
Phase 2
ASP-1929 + Anti-PD-1 Combination Therapy
Locoregional, recurrent head and neck squamous cell carcinoma (first-line treatment)
Global
ASP-1929-381
Phase 3
Recurrent or metastatic head and neck squamous cell carcinoma or locally advanced or metastatic cutaneous squamous cell carcinoma
US
ASP-1929-181 2
Phase 1b/2
Locoregional recurrent head and neck squamous cell carcinoma
Taiwan
ASP-1929-218 2
Phase 2
Unresectable advanced or recurrent esophageal cancer or gastric cancer
Japan
GE-PIT 3
(Investigator-initiated study)
Phase 1
RM-1995
Advanced or recurrent solid tumors with liver metastases
Japan
RM-1995-102 4
Phase 1
RM-0256
TBD
TBD
TBD
Pre-clinical
-
- 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.
- Currently not recruiting
- Completed study
- Funded by the Japan Agency for Medical Research and Development (AMED).
This pipeline chart represents a selection of the developmental product candidates based on the Alluminox™ platform and it is designed to demonstrate our commitment to patients as we strive to accomplish our corporate mission to conquer cancer. The 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 February 2025, 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.
