一次情報の記録
決定級試験登録の変更
TuHURA、Merkel細胞がんを対象としたIFx-2.0＋Keytrudaの第3相試験を開始
TuHURAは、FDAの特別プロトコル評価の下、初回治療の進行性または転移性Merkel細胞がんを対象に、IFx-2.0とpembrolizumabの併用療法に関する単回無作為化プラセボ対照第3相登録試験を開始した。本試験は加速承認経路を採用し、主要評価項目をORR、重要な副次的評価項目をPFSとし、PFSは通常承認への移行を支える可能性がある。
主要事実
出典の抜粋
EX-99.1 2 d73851dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Business Except as otherwise specified or indicated by the context, references to “we,” “us,” “our” or the “company” are to TuHURA Biosciences, Inc. and its wholly owned subsidiaries. Overview We are a clinical stage immuno-oncology company with three distinct technologies focused on the development of novel therapeutics designed to overcome primary and acquired resistance to cancer immunotherapies. Our proprietary Immune FxTM technology platform, or IFx, is an innate immune agonist technology designed to “trick” the body’s immune system to attack tumor cells by making tumor cells look like bacteria. Our lead product candidate, IFx2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. I