Takara Bio Inc. (Takara Bio) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the clinical development program for gene therapy drug candidate NY-ESO-1・siTCR™ (Development Code: TBI-1301) has received the Orphan Regenerative Medicine designation by the Ministry of Health, Labour and Welfare in Japan. NY-ESO-1/siTCR™ is in development for synovial sarcoma.
TBI-1301, TCR gene-engineered T cell therapy, is being developed by Takara Bio. In April 2018, Takara Bio entered into an agreement with Otsuka for co-development/exclusive sales of TBI-1301 in Japan and has since been engaged in co-development. Both companies will work cooperatively to develop TBI-1301 for early launch in Japan.
This is an English translation from Japanese press release.