Shiga, Japan – Jun 1, 2022 - Takara Bio Inc., an innovative biotechnology company, announced that the results from the investigator-initiated clinical trial in Canada of NY-ESO-1・siTCR~{TM} gene therapy* will be presented at the 2022 Annual Meeting of the American Society of Clinical Oncology (June 3 - 7, 2022, Chicago, Illinois, U.S.).
*Development Code: TBI-1301, INN: mipetresgene autoleucel



[Outline of presentation]

Name of Conference

ASCO (American Society of Clinical Oncology) Annual Meeting 2022


McCormick Place (Chicago, Illinois, U.S.)


June 5, 8:00 am – 11 am (Local time)


The addition of fludarabine to cyclophosphamide for lymphodepleting chemotherapy enhances the persistence of infused NY-ESO-1 TCR anticancer therapy TBI-1301


[Objectives, Methods]
In this study, we examined a repeat infusion of TBI-1301 and the addition of fludarabine to cyclophosphamide for pre-infusion lymphodepletion. Repeat infusions were performed in two cohorts: Cohort B - patients who had previously received NY-ESO-1 TCR-transduced cells and Cohort C - NY-ESO-1 TCR treatment naïve patients. Ten patients in total were enrolled (5 for each cohort) and nine patients in total are evaluable for response and toxicity (cohort B: 5, cohort C: 4).
- no DLTs have been observed
- In each cohort, 4 patients experienced grade 1-2 cytokine release syndrome.
- Best overall response by RECIST v1.1 was 3 stable disease, and 2 progressive disease in cohort B; and 2 stable disease and 2 progressive disease in cohort C.
- Biomarker analysis demonstrated substantially longer persistence of transferred TBI-1301 cells in infused patients who received fludarabine and display a less differentiated phenotype.
Repeat infusions of TBI-1301 following lymphodepletion appears to be safe and to possess anti-tumor activity. Addition of FLU to lymphodepletion regimen may contribute to longer persistence of gene-engineered T cells.


click here for the poster 

Throughout its leading biotechnology, Takara Bio is dedicated to continue working on to develop new modalities for ex vivo gene therapy as well as in vivo gene therapy to contribute good health of humankind.