Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
June 24, 2020

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

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・siTCRTM has received the Orphan Regenerative Medicine designation by the Ministry of Health, Labour and Welfare in Japan. NY-ESO-1/siTCRTM is in development for synovial sarcoma.

Takara Bio, the originator of NY-ESO-1/siTCRTM, is co-developing this candidate with Otsuka based on a co-development and exclusive sales agreement covering Japan signed in April 2018.

NY-ESO-1/siTCRTM (development code: TBI-1301, and international nonproprietary name: mipetresgene autoleucel) is a TCR gene transfer T-cell therapy (TCR T-cell therapy).