Business
TuHURA Biosciences, Inc. (Nasdaq: HURA) Outlines Development Pathway for Single Phase 3 Accelerated Approval Registration Trial in First Line Treatment of Advanced or Metastatic Merkel Cell Carcinoma and Provides Business Update
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
About this update from Tuhura Biosciences, Inc.
[{"type":"text","content":"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)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 antibodyAdvancing IFx-3.0, the first systemically administered tumor-targeted mRNA innate immune response agonist for aggressive B Cell LymphomaEarly 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)Company expands leadership team with key clinical and regulatory appointments to drive strategy and operational execution TAMPA, FL / ACCESSWIRE / November 25, 2024 / TuHURA Biosciences, Inc. (Nasdaq:HURA) (\"TuHURA\" or the \"Company\"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today provided a business update and outlined upcoming targeted milestones. \"We have made significant progress toward accomplishing our 2024 corporate objectives, including reaching a Special Protocol Assessment agreement with the FDA by working with the Oncology Center of Excellence (OCE) and FDA's Project Front Runner initiative for a novel Phase 3 trial design for IFx-2.0 under the FDA's accelerated approval pathway. This single registration directed trial, in addition to its primary endpoint of Overall Response Rate (ORR), it will also incorporate a key secondary endpoint of Progression Free Survival (PFS) that, if achieved, can satisfy the requirement for a post-approval confirmatory trial, potentially converting accelerated approval to full approval,\" commented James Bianco, M.D., President and Chief Executive Officer of TuHURA. \"We have also advanced our efforts toward the potential acquisition of KVA12123, a novel VISTA inhibiting antibody, with a non-binding letter of intent, which would bring to our pipeline a Phase 2 ready candidate with therapeutic synergies across our pipeline and technologies, all while b...