Kusatsu/Shiga Japan – February 14, 2019 – Takara Bio Inc. (Takara Bio), announced today that a NY-ESO-1・siTCR™ gene therapy product (Development code: TBI-1301) for synovial sarcoma co-developed by Takara Bio and Otsuka Pharmaceutical Co., Ltd, (Otsuka) in Japan has been approved for the description change of product under SAKIGAKE Designation System (hereinafter, “SAKIGAKE”) by the Ministry of Health, Labour and Welfare as of February 14, 2019.
Takara Bio is conducting domestic Phase I/II clinical trial of TBI-1301 targeting synovial sarcoma since January 2017, and it has been designated as a SAKIGAKE product in March 2018. This designation change is based on the agreement that Takara Bio has concluded with Otsuka for domestic co-development and exclusive sales in April 2018.
Both companies will aim cooperatively for co-development of this product.
* Anti-tumor therapy for synovial sarcoma, which a receptor gene recognizing tumor antigen, is transduced ex-vivo to patients' lymphocytes, and the gene-modified lymphocytes are infused back to patients
AnnouncemAnnouncement on product designation of NY-ESO-1・siTCR gene therapy product for synovial sarcoma under “SAKIGAKE Designation System” by the Ministry of Health, Labour and Welfare (Released on March 27, 2018)
Takara Bio entered into an agreement for co-development/exclusive sales of NY-ESO-1 siTCR and CD19 CAR gene therapy with Otsuka (Released on April 9, 2018)