{"id":7191,"date":"2020-08-18T00:42:21","date_gmt":"2020-08-18T07:42:21","guid":{"rendered":"https:\/\/2020dev.rakuten-med.com\/?page_id=7191"},"modified":"2026-02-24T16:42:51","modified_gmt":"2026-02-25T00:42:51","slug":"pipeline","status":"publish","type":"page","link":"https:\/\/rakuten-med.com\/us\/pipeline\/","title":{"rendered":"Pipeline"},"content":{"rendered":"
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\n\t\t\t\t\t\tPipeline\t\t\t\t\t\t<\/h1>\n\t\t\t\t\t\t<\/div>\n<\/div><\/div><\/div><\/div><\/div>
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Rakuten Medical is developing <\/span>Alluminox\u00ae platform<\/span><\/a>-based photoimmunotherapy<\/span> for patients around the world.<\/span><\/p>\n

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Alluminox\u00ae 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\u00ae 700DX [IR700]) that selectively binds the surface of target cells, such as tumor cells.<\/span><\/p>\n

 <\/p>\n

Rakuten Medical is developing drugs using a variety of cell-targeting moieties including antibodies, in its drug discovery program, Alluminox Palette\u2122. ASP-1929 (Japanese brand name: Akalux\u00ae 250 mg for intravenous infusion) received marketing approval for unresectable locally advanced or recurrent head and neck cancer in Japan.<\/span><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>

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The pipeline for Alluminox\u00ae platform using these drug candidates is as follows.<\/p>\n

As of October 2025<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>

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Indication<\/strong><\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Region<\/strong><\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Trial Name<\/strong><\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase<\/strong><\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Trial Info<\/strong><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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ASP-1929<\/span><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Locoregional, recurrent head and neck squamous cell carcinoma<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Global<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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ASP-1929-301<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 3<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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ClinicalTrials.gov (NCT03769506)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Unresectable locally advanced or recurrent head and neck cancer (after 4th<\/sup> treatment cycle)<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Japan<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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ASP-1929-402
\n(Post-marketing clinical trial) 1 2<\/sup><\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 4<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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jRCT (jRCT2041230050)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Operable primary or recurrent head and neck or cutaneous squamous cell carcinoma<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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US<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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ASP-1929-103 2<\/sup>
\n(Window of Opportunity study)<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 2<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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ClinicalTrials.gov (NCT05182866)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Esophageal cancer<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Japan<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Ex-PIT
\n(Investigator-initiated study)<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 1b\/2<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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jRCT (jRCT2080224666)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Locally advanced or recurrent vulvar, vaginal, and cervical cancers<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Japan<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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HiCARi4<\/sup>
\n(Investigator-initiated study)<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 2<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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jRCT (jRCT2011240034)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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ASP-1929 + Anti-PD-1 Combination Therapy<\/span><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Locoregional, recurrent head and neck squamous cell carcinoma (first-line treatment)<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Global<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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ASP-1929-381<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 3<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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ClinicalTrials.gov (NCT06699212)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Recurrent or metastatic head and neck squamous cell carcinoma or locally advanced or metastatic cutaneous squamous cell carcinoma<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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US<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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ASP-1929-181 2<\/sup><\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 1b\/2<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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ClinicalTrials.gov (NCT04305795)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Locoregional recurrent head and neck squamous cell carcinoma<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Taiwan<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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ASP-1929-218 2<\/sup><\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 2<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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ClinicalTrials.gov (NCT05265013)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Unresectable advanced or recurrent esophageal cancer or gastric cancer<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Japan<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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GE-PIT 3<\/sup>
\n(Investigator-initiated study)<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 1<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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jRCT (jRCT2080224884)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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RM-1995<\/span><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Advanced or recurrent solid tumors with liver metastases<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Japan<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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RM-1995-102 2 4<\/sup><\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Phase 1<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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jRCT (jRCT2031220721)<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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RM-0256<\/span><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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Solid tumors<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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Japan<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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TBD 4<\/sup><\/p>\n<\/div>\n\t\t<\/div><\/div><\/div>

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(Preparing for clinical trial)<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div>

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-<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>