Kusatsu/Shiga, Japan — May 31, 2018 – Takara Bio Inc. announces that final results from the US Phase II clinical trial of HF10, a replication-competent HSV-1 Oncolytic Virus, namely Canerpaturev (abbreviated to C-REV) will be presented at the 2018 Annual Meeting of the American Society of Clinical Oncology (June 1 – 5, 2018, Chicago, Illinois, U.S.)
【Outline of presentation】
|Name of conference||
ASCO (American Society of Clinical Oncology) Annual Meeting 2018
|Place||McCormick Place (Chicago, Illinois, U.S.)|
Efficacy and Genetic Analysis for a Phase II Multicenter Trial of HF10, a Replication-competent HSV-1 Oncolytic Immunotherapy, and Ipilimumab Combination Treatment in Patients with Stage IIIB-IV Unresectable or Metastatic Melanoma
Enrollment: Of 46pts enrolled and treated: 20% IIIB, 43% IIIC, 37% IV; 43% with ≥ 1 prior cancer therapy for unresectable/metastatic melanoma.
Safety: No DLTs were reported.
Efficacy: Of the 44 efficacy evaluable pts, BORR at 24 weeks was 41%; disease stability rate was 68%. As of February 2017, median PFS was 19 months and median survival was 26 months.
Conclusion: The combination treatment with HF10 and ipilimumab exhibited antitumor activity in activating adaptive immune response with increased total tumor infiltrating lymphocytes and CD8+ T-cells, and decreased CD4+ T-cells.
Takara Bio is conducting the clinical trials of HF10 (Canerpaturev) in Japan and the U.S.. The Japanese phase II clinical trial for melanoma is being conducted, aiming the NDA (new drug application) submission in FY2018. In the U.S., the investigator-initiated phase II trial of neoadjuvant immunotherapy in combination of HF10 with antitumor drug, nivolumab is also ongoing at the University of Utah.
Oncolytic viruses selectively replicate within cancer cells and break it down without giving excessive damage to normal cells. Virus released from cells destructed via such replication spreads to infect other cells, and further the fragmentation from destructed cancer cells is expected to lead to the tumor shrinkage even on uninjected tumors by strengthening immunity to cancer cells. This type of virus is called an oncolytic virus.
HF10 is an attenuated strain of the herpes simplex virus 1 (HSV-1) and exhibits antitumor activity when inserted into a cancerous region. Takara Bio has entered into an exclusive licensing agreement for domestic co-development and exclusive sales of oncolytic virus HF10 with Otsuka Pharmaceutical Co., Ltd. in December 2016. An international nonproprietary name assigned to HF10 pharmaceutical products is Canerpaturev made through a review by WHO (World Health Organization).
(Reference) WHO Drug Information, Vol.32, No1, 2018
Melanoma is the malignant type of skin cancer. Skin cells which make the pigment melanin are called melanocytes, and melanoma is known to be a form of cancer which melanocytes or nevus cells (cells in mole) become malignant.
Cytotixic T lymphocyte (CTL) recognize and attack cancer cells, whereas it may not exhibit anti-tumor activity occasionally by having inhibitory function against one’s excessive immune response. Ipilimumab and Nivolumab binds with PD-1 and CTLA-4 molecule on the surface of CTL, respectively. Both are pharmaceutical products (immune checkpoint inhibitory agents) enhancing anti-tumor activity by cancelling this inhibitory function.