原始来源记录
决策级临床试验登记变更
TuHURA 启动 IFx-2.0 联合 Keytruda 治疗 Merkel 细胞癌的 3 期试验
TuHURA 已启动一项单次随机安慰剂对照 3 期注册试验，评估 IFx-2.0 联合 pembrolizumab 用于一线晚期或转移性 Merkel 细胞癌，并获得 FDA 特别方案评估。该试验采用加速批准途径，以 ORR 作为主要终点，PFS 作为关键次要终点，可支持转为常规批准。
关键事实
来源摘录
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