Kusatsu/Shiga, Japan — January 15, 2019 – Takara Bio Inc. announces that preliminary results from Phase I clinical trial in Japan of C-REV (canerpaturev, former HF10), an oncolytic viral immunotherapy will be presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2019 Congress.
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Name of conference |
ASCO-GI (American Society of Clinical Oncology Gastrointestinal Cancers Symposium) 2019 (January 17 – 19, 2019) |
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Place |
Moscone Center (SanFrancisco, California, U.S.) |
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Date |
January 18 11:30-13:00, 17:30-18:30 (Local time) |
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Title |
Results from Phase I study of the oncolytic viral immunotherapy agent Canerpaturev (C-REV) in combination with Gemcitabine plus Nab-paclitaxel for Unresectable Pancreatic Cancer |
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Summary |
<Purpose> Evaluation of safety and antitumor activity data to determine the recommended dose of C-REV in combination with Gemcitabine plus Nab-paclitaxel called G-nP chemotherapy
<Enrollment> Of 6 Japanese pts enrolled and treated: Disease stage III 2 cases, IV 4 cases
<Method> ・C-REV injection (1x106 or 1x107 TCID50/mL, up to 2 mL depending on tumor size, EUS-guidance injections q2wk) G-nP therapy (1,000 mg/m2 Gemcitabine, 125 mg/m2 Nab-paclitaxel on days 1, 8, 15 of a 4-week cycle) ・Study treatment could continue up to 1 year if eligible for injection.
<Safety> ・No DLTs were reported at the dosage up to 1x107 TCID50/mL. ・17% (1/6) pt(s) had C-REV-related ≥G3 AE, and it was acute pancreatitis (G3). ・G-nP-related ≥G3 AEs observed in not less than 2 pts were neutropenia (3 cases (50%)), and all of ≥G3 AEs related to G-nP therapy were AEs previously reported in G-nP therapy
<Efficacy> (As of September 1, 2018) Of the 6 efficacy evaluable pts, BORR was 67% (4/6 cases); disease control rate was 100% (6/6 cases).
<Conclusion> The recommended dose was determined as 1x107 TCID50/mL. The combination of C-REV and the standard chemotherapy demonstrated a favorable benefit/risk profile and encouraging antitumor activity in patients with unresectable pancreatic cancer. |
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Following the above phase I trial, Takara Bio is going ahead with the expansion cohort study including the use of S-1 for 2nd line treatment in addition to 1st line combination treatment with Gemcitabine plus Nab-paclitaxel. It allows concurrent data collections for evaluation of safety and antitumor activity from several treatment patterns.
Further, the clinical trials of C-REV in Japan and the U.S. are ongoing, aimed at the early NDA (new drug application) submission for melanoma. In the U.S., the investigator-initiated trial of C-REV plus nivolumab (anti-PD-1 antibody) in neoadjuvant setting is also conducted at the University of Utah.
Announcement on submission of the Clinical Trial Plan Notification for phase I clinical trial of Oncolytic virus HF10 against pancreatic cancer in Japan
(Released on June 1, 2017)
http://ir.takara-bio.co.jp/en/news_all/news_Release/news_Release3357967336264589153.html
First patient enrolled into phase I clinical trial of Oncolytic Virus HF10 against pancreatic cancer in Japan
(Released on September 27, 2017)
http://ir.takara-bio.co.jp/en/news_all/news_Release/news_Release-9122625355156947770.html
1. Oncolytic virus
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.
2. C-REV (canerpaturev, formerly HF10)
C-REV 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 C-REV with Otsuka Pharmaceutical Co., Ltd. in December 2016.
