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TuHURA Biosciences Outlines Development Pathway For Single Phase 3 Accelerated Approval Registration Trial

TuHURA Biosciences Outlines Development Pathway For Single Phase 3 Accelerated Approval Registration Trial

TuHURA生物科技概述了单一三期加速批准注册试验的发展路径
Benzinga ·  2024/11/25 21:40

IFx-2.0, a first-in-class innate immune response agonist, entering single Phase 3 accelerated approval registration trial in first half of 2025 for first line treatment of Merkel Cell Carcinoma (MCC) under Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA)

IFx-2.0,首款内源性免疫应答激动剂,将于2025年上半年进入单一3期加速审批注册试验,用于梅克尔细胞癌(MCC)的一线治疗,并与美国食品和药物管理局(FDA)签订特殊方案评估(SPA)协议。

Entered into a non-binding letter of intent with Kineta regarding a potential transaction in which TuHURA would acquire the rights to KVA12123 expanding its pipeline with a Phase 2 ready, novel VISTA inhibiting antibody

与Kineta达成了一份非约束性的意向书,涉及TuHURA可能收购KVA12123的权利,从而扩展其管线,增加一款准备进入2期的、创新的VISTA抑制抗体。

Advancing IFx-3.0, the first systemically administered tumor-targeted mRNA innate immune response agonist for aggressive B Cell Lymphoma

推进IFx-3.0,首个系统性给药的肿瘤靶向mRNA内源性免疫应答激动剂,用于治疗侵袭性的B细胞淋巴瘤。

Early discovery programs designing first-in-class tumor microenvironment modulating bi-specific antibody drug conjugates (ADCs) or peptide drug conjugates (PDCs) targeting Myeloid Derived Suppressor Cells (MDSCs)

早期研发项目设计首款肿瘤微环境调节双特异性抗体药物偶联物(ADCs)或肽药物偶联物(PDCs),针对髓源抑制细胞(MDSCs)。

Company expands leadership team with key clinical and regulatory appointments to drive strategy and operational execution

公司通过关键的临床和监管任命扩大领导团队,以推动策略和运营的执行。

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