Announcement on investigator-initiated clinical trial of neoadjuvant combination therapy with HF10 and Nivolumab

Kusatsu Shiga, Japan―December 21 , 2017― Takara Bio Inc. (Takara Bio) announced today it has entered into an agreement with Huntsman Cancer Institute (HCI) at the University of Utah to supply its lead product candidate, oncolytic virus HF10 as an investigational drug. Under the agreement HCI will conduct an investigator-initiated clinical trial of combined treatment of HF10 and cancer drug, nivolumab, in patients with resectable Stage IIIB, IIIC and IVM1a melanoma.

Takara Bio is currently conducting clinical development of HF10, and obtained positive results on safety and efficacy in the phase II trial of HF10 in combination with cancer drug, ipilimumab, for patients with unresectable melanoma in US. The clinical trial conducted at HCI, will evaluate safety and efficiency of HF10 in combination with nivolumab which is accepted as one of the standard therapies for cancer. Takara Bio expects to expand the usage of HF10 through the clinical trial at HCI.

Takara Bio promotes development of HF10 as a drug for melanoma and pancreatic cancer, and 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, for early commercialization in Japan.

【Overview of the clinical trial】

Study name Phase II Clinical Trial for preoperative immunotherapy of HF10 and nivolumab combination in patients with resectable melanoma (stage IIIb, IIIIc and IVM1a)
Condition Patients with resectable melanoma (stage IIIb, IIIIc and IVM1a)
Main Endpoint Pathological response rate of preoperative immunotherapy for 12 weeks
Estimated Enrollment 20
Duration Jan 2018 – October 2022