Catatan sumber primer
PenentuPerubahan registri uji klinis
TuHURA memulai uji coba Fase 3 IFx-2.0 + Keytruda pada karsinoma sel Merkel
TuHURA memulai uji coba registrasi Fase 3 acak tunggal yang dikendalikan plasebo untuk IFx-2.0 ditambah pembrolizumab pada karsinoma sel Merkel lanjut atau metastatik lini pertama berdasarkan Penilaian Protokol Khusus FDA. Uji coba ini menggunakan jalur persetujuan yang dipercepat dengan ORR sebagai titik akhir primer dan PFS sebagai titik akhir sekunder utama yang dapat mendukung konversi ke persetujuan reguler.
Fakta utama
- Diajukan
- 3 Nov 2025, 21.10
- Peristiwa
- Perubahan registri uji klinis
- Arah
- Positif
- Perusahaan
HURATuHURA Biosciences- Aset
- IFx-2.0
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
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