J-Pharma Announces Publication of Abstracts of updates on the Japanese Phase II Study of Nanvuranlat (Development code: JPH203) at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium

January 18, 2023
J-Pharma Co., Ltd.

Primary endpoint results of a randomized, double-blind, placebo-controlled Phase II trial of Nanvuranlat (L-type amino acid transporter (LAT1) inhibitor) in patients with pre-treated, advanced, refractory biliary tract cancer will be presented in the oral presentation
Nanvuranlat, a novel small molecular compound discovered and developed by J-Pharma, is the first LAT1-targeted compound undergoing clinical studies and will become the first-in-class medicine when approved by competent authorities
Oral presentation: January 20, 2023, 7:10 AM Pacific Standard Time
(January 21, 2023, 12:10 AM Japan Standard Time)

J-Pharma today announced the publication of the abstract highlighting an updated Japanese Phase II study of Nanvuranlat in advanced biliary tract cancer (hereafter referred to as “the Study”) on the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2023) website in advance of its presentation.

https://meetings.asco.org/abstracts-presentations/217774

1. Title
Nanvuranlat, an L-type amino acid transporter (LAT1) inhibitor for patients with pretreated advanced refractory biliary tract cancer (BTC): Primary endpoint results of a randomized, double-blind, placebo-controlled phase 2 study

2. Summary of the Study
Randomized, double-blind, placebo-controlled, phase II trial of Nanvuranlat in patients with pre-treated, advanced, refractory biliary tract cancer, patients with four different subtypes of advanced biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of Vater cancer) were enrolled. All were refractory to or intolerant of standard chemotherapy and other investigational medicines. Fourteen Japanese institutions participated in the Study. After obtaining consent from 211 patients, 106 patients (Nanvuranlat: 70, placebo: 36) were enrolled and pre-classified based on polymorphisms of drug-metabolizing enzymes N-acetyltransferase 2 (NAT2).
The primary endpoint was progression-free survival (PFS).
Clinical study information: UMIN000034080

3. About results of the Study (Summary)
PFS of Nanvuranlat demonstrated a statistically significant improvement over the placebo group (Hazard ratio= 0.557, 95% CI=0.3435-0.9029, p = 0.0164) therefore, the Study met its primary endpoint. LAT1 inhibitor monotherapy with Nanvuranlat demonstrated useful clinical efficacy in patients with four different subtypes of pre-treated, advanced, refractory biliary tract cancer.
A safe and highly tolerated profile was also documented.

About Nanvuranlat
Nanvuranlat, a novel small molecular compound discovered and developed by J-Pharma, selectively inhibits the amino acid binding pocket of L-type amino acid transporter (LAT1) by expressing on the cell membrane when cells need huge amounts of energy due to rapid proliferation and/or activation. Nanvuranlat is the first LAT1-targeted compound undergoing clinical studies and will become the first-in-class medicine when approved by competent authorities.

Forward-Looking Statement
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Contact: Tomohiro Yuzawa, Director,
Corporate Management
Tel: 045-506-1155
info@j-pharma.com