Clinical program for NY-ESO-1/siTCR gene therapy candidate receives designation in Japan as Orphan Regenerative MedicineTM

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Takara Bio Inc. (Takara Bio) announce that the clinical development program for gene therapy drug candidate NY-ESO-1・siTCR has received the Orphan Regenerative Medicine designation by the Ministry of Health, Labour and Welfare in Japan. NY-ESO-1/siTCRis in development for synovial sarcoma. TMTM Takara Bio, the originator of NY-ESO-1/siTCR, is co-developing this candidate with Otsuka based on a co-development and exclusive sales agreement covering Japan signed in April 2018. TM NY-ESO-1/siTCR (development code: TBI-1301, and international nonproprietary name: mipetresgene autoleucel) is a TCR gene transfer T-cell therapy (TCR T-cell therapy). TM

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