原始出處紀錄
決策級臨床試驗登錄異動
TuHURA 啟動 IFx-2.0 合併 Keytruda 用於 Merkel 細胞癌的第三期試驗
TuHURA 已啟動一項單一隨機安慰劑對照的第三期註冊試驗，評估 IFx-2.0 合併 pembrolizumab 用於第一線晚期或轉移性 Merkel 細胞癌，並獲得 FDA 特別方案評估。該試驗採用加速核准途徑，以客觀緩解率（ORR）為主要終點，無惡化存活期（PFS）為關鍵次要終點，可支持轉為常規核准。
關鍵事實
來源摘錄
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