Kusatsu/Shiga, Japan — January 30, 2017 — Takara Bio Inc. (Takara Bio), today announced that the Clinical Trial Notification was submitted to PMDA (Pharmaceuticals and Medical Devices Agency; Japanese regulatory agency) to conduct phase II clinical trial of oncolytic virus HF10 (Development code: TBI-1401) in Japan.
The clinical trial will be conducted in patients with unresectable or metastatic melanoma to evaluate efficacy and safety with the intratumoral injections of HF10 in combination with intravenous ipilimumab. The HF10 manufactured at Center for Gene and Cell Therapy, Takara Bio’s facility, will be used in the clinical trial.

After the clearance, the protocol will be reviewed by each IRB (Institutional Review Board) and the study will be initiated.

Takara Bio is currently conducting Phase II clinical trial in the US and Phase I clinical trial in Japan. 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. Takara Bio attempts to achieve the accelerated 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 HF10 cancer therapy in the fiscal year 2018.

【Overview of the Clinical Trial】

Study name Phase II Clinical Trial of combination with TBI-1401 (HF10) and ipilimumab in patients with unresectable or metastatic melanoma (stage IIIB, IIIC or IV)
Condition Patients with unresectable or metastatic melanoma
Main Endpoint Best overall response rate (BORR) based on irRC at Week 24
Estimated Enrollment 25
Duration April 2017 – June 2018
Site National Cancer Center Hospital, and others, total 12 sites