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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 April 2025

Indication

Region

Trial Name

Phase

Trial Info

ASP-1929

Locoregional, recurrent head and neck squamous cell carcinoma

Global

ASP-1929-301

Phase 3

ClinicalTrials.gov (NCT03769506)

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

jRCT (jRCT2041230050)

Operable primary or recurrent head and neck or cutaneous squamous cell carcinoma

US

ASP-1929-103 2
(Window of Opportunity study)

Phase 2

ClinicalTrials.gov (NCT05182866)

Esophageal cancer

Japan

Ex-PIT
(Investigator-initiated study)

Phase 1b/2

jRCT (jRCT2080224666)

Locally advanced or recurrent vulvar, vaginal, and cervical cancers

Japan

HiCARi4
(Investigator-initiated study)

Phase 2

jRCT (jRCT2011240034)

ASP-1929 + Anti-PD-1 Combination Therapy

Locoregional, recurrent head and neck squamous cell carcinoma (first-line treatment)

Global

ASP-1929-381

Phase 3

ClinicalTrials.gov (NCT06699212)

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

ClinicalTrials.gov (NCT04305795)

Locoregional recurrent head and neck squamous cell carcinoma

Taiwan

ASP-1929-218 2

Phase 2

ClinicalTrials.gov (NCT05265013)

Unresectable advanced or recurrent esophageal cancer or gastric cancer

Japan

GE-PIT 3
(Investigator-initiated study)

Phase 1

jRCT (jRCT2080224884)

RM-1995

Advanced or recurrent solid tumors with liver metastases

Japan

RM-1995-102 4

Phase 1

jRCT (jRCT2031220721)

RM-0256

Solid tumors

Japan

TBD 4

(Preparing for clinical trial)

-

  1. 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. 
  2. Currently not recruiting
  3. Completed study
  4. 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 April 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.

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