Company: HURA
Filing Date: 2025-05-05
Form Type: 425
Source: 0000950170-25-063170
Chunk: 0

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-05
Form: 425
Chunk 0
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Filed pursuant to Rule 425 under the
Securities Act of 1933, as amended, and
deemed filed under Rule 14a-12 under the
Securities Exchange Act of 1934, as amended

Filer: TuHURA Biosciences, Inc.
Filer’s Commission File No.: 001-37823

Subject Company: Kineta, Inc.
Commission File No.: 001-37695

<div align='center'>TuHURA Biosciences, Inc. Initiates Phase 1b/2a Study of IFx-Hu2.0 as an Adjunctive Therapy to Keytruda®(pembrolizumab) in First Line Treatment for Metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP)

Phase 1b/2a trial designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytruda®when administered via Interventional Radiology (IR) in patients with deep- seated tumors without associated cutaneous tumors</div>

TAMPA, Fla., May 5, 2025 - TuHURA Biosciences, Inc.(NASDAQ:HURA) (“TuHURA” or the “Company”), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced the initiation of its Phase 1b/2a trial of IFx-Hu2.0, TuHURA’s lead innate immune agonist, in patients with MCCUP who would not be eligible for the Company’s planned Phase 3 accelerated approval trial, which is targeted to begin enrollment later in Q2 2025. IFx-Hu2.0 is designed to overcome primary resistance to checkpoint inhibitors (CPIs) like Keytruda®and has demonstrated systemic anti-tumor specific immune responses (abscopal effect) when injected intratumorally into cutaneous, subcutaneous, or accessible nodal lesions in its prior Phase 1 and 1b trials in melanoma and advanced or metastatic Merkel cell carcinoma (MCC).

“Like our planned Phase 3 accelerated approval trial, this Phase 1b/2a trial will also investigate the ability of IFx-Hu2.0 to increase the anti-tumor response rate when used alongside Keytruda®in first line treatment of CPI naïve, metastatic MCC. However, unlike the planned Phase 3 study, these are patients without skin lesions who present with metast