Kusatsu/Shiga, Japan — Jun 1, 2017 — Takara Bio Inc. (Takara Bio) announced that the Clinical Trial Notification was submitted to PMDA (Pharmaceuticals and Medical Devices Agency; Japanese regulatory agency) to conduct phase I clinical trial of oncolytic virus HF10 (Development code: TBI-1401) as regenerative medicine product in Japan on May 31.
This clinical trial will be conducted in patients with unresectable advanced pancreatic cancer to evaluate safety of HF10 in combination with existing chemotherapeutic drug.
After the clearance, the protocol will be reviewed by each IRB (Institutional Review Board) and the study will be initiated. In this clinical trial, the HF10 manufactured at Center for Gene and Cell Therapy, Takara Bio’s facility, will be used.
Takara Bio is currently conducting clinical trials in patient with unresctable and metastatic melanoma in Japan and US. Based on the results which were obtained so far, the intratumoral injections of HF10 are safe and well-tolerated, and encouraging tumor response was demonstrated. And also, the investigator-initiated clinical research for pancreatic cancer was completed, and the good results were reported*.
* 91th Annual Meeting of the Japan Gastroenterological Endoscopy Society (JGES),May 12, 2016

【Overview of the Clinical Trial】

Study name Phase I Clinical Trial of combination with TBI-1401 (HF10) and gemcitabin plus nab-paclitaxel in patients with unresectable pancreatic cancer
Condition Patients with unresectable advanced pancreatic cancer (Stage III or IV)
Drug Administration method HF10(TB-1401) is intra-tumorally injected under EUS guided
Primary Endpoint Dose Limiting Toxicity
Estimated Enrollment 6 (maximum12)
Duration July 2017 – January 2019

National Cancer Research Center East Hospital and other
(2 sites in total)


Regarding domestic development and sales of oncolytic virus HF10, Takara Bio have exclusive licensing agreement with Otsuka Pharmaceutical Co., Ltd., and both companies will consult with each other and aim for the early approval of HF10 in Japan.