Kusatsu/Shiga, Japan — January 17, 2018 — Takara Bio Inc. (Takara Bio), today announced that the first patient with synovial sarcoma has been enrolled into NY-ESO-1・siTCR gene therapy (TBI-1301) phase I/II clinical trial in Japan on January 15-16, 2018.
In the clinical trial, the gene of TCR which recognizes NY-ESO-1 antigen, a tumor antigen, is transferred ex-vivo to lymphocytes of patients, and the gene-modified lymphocytes are infused back to the patients. The patients will be monitored for safety and efficacy. The Takara Bio’s method for gene transduction, T-cell expansion methods using RetroNectinsup{®}, and Takara Bio’s original retroviral vectors for siTCR transduction will be used during the cell processing for the clinical trial. NY-ESO-1・siTCR gene transduced lymphocytes manufactured at Center for Gene and Cell Therapy (Kusatsu, Shiga), Takara Bio’s facility, will be used.
Takara Bio attempts to achieve the early-approval utilizing the conditional and term-limited approval system for regenerative medicine under The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical devices. Takara Bio aims to commercialize the NY-ESO-1・siTCR gene therapy in the fiscal year 2020.

“Announcement on submission of the Clinical Trial Plan Notification for phase I/II clinical trial of NY-ESO-1・siTCR gene therapy in Japan” - Our news release January 24, 2017