Kusatsu/Shiga, Japan – September 14, 2015 – Takara Bio Inc. announced that the HF10 US Phase I clinical trial data will be presented at the 40th Congress of European Society for Medical Oncology.

【Outline of presentation】

Name of the conference The 40th Congress of European Society for Medical Oncology
Place Vienna (Austria)
Date 16:45 to 18:45, September 27 (Local time)
Program Poster Session: Melanoma and Skin Cancer
Title Delayed Tumor Response and Safety Profile in Patients with Refractory Superficial Cancers Treated with Intratumoral Injections of HF10, an oncolytic HSV-1

【Safety】No serious adverse event was observed. Among 24 evaluable subjects, 9 subjects experienced adverse events which were considered to be at least possibly related the drug. But all of these events were rated as Grade 2 or milder in severity. Presence or absence of anti-HSV-1 antibody at baseline had no effect on profile of adverse reaction. 【Efficacy】By the end of the evaluation period (10 weeks from the initial dose), 7 of 24 evaluable subjects achieved local SD (SD at the administration site), and 8 of 24 subjects achieved overall SD (SD at the administration site and other sites).


HF10 showed marked effect on melanoma: 6 of 9 evaluable subjects achieved overall SD. Among these 6 subjects, 1 subject showed reduction in tumor by 45% at the HF10 administration site. No subject achieved complete response or partial response.


In the follow-up period following evaluation period, delayed tumor response was observed in 3 melanoma subjects without additional treatment. Tumor completely disappeared at administration site in 2 of these 3 subjects.


For oncolytic virus HF10, a Phase II clinical trial in the U.S. against melanoma, and a Phase I clinical trial in Japan against solid cancers such as melanoma and squamous carcinoma are under way. Takara Bio will continue the clinical development of HF10, targeting putting it on commercial basis in fiscal 2018.