Company: HURA
Filing Date: 2025-05-15
Form Type: 425
Source: 0000950170-25-072703
Chunk: 6

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-15
Form: 425
Chunk 6
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unctive Therapy to Keytruda in 1L MCCUP. In May 2025, TuHURA announced that it initiated its Phase 1b/2a trial of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in MCCUP. This Phase 1b/2a trial is investigating safety and feasibility of IFx-Hu2.0 when administered via interventional radiology to patients with deep-seated tumors who would not be eligible for the Phase 3 trial.

Presentation of Two Posters at the American Academy of Cancer Research (AACR) Annual Meeting. In April 2025, TuHURA presented a poster at the AACR Annual Meeting outlining a greater than 90% VISTA receptor occupancy following treatment with the Kineta’s VISTA inhibitor mAb as monotherapy and in combination with pembrolizumab in advanced solid tumors. Additionally, the Markowitz Lab at Moffitt Cancer Center presented a poster of IFx-Hu2.0, demonstrating increased T Cell and B Cell production in peripheral blood relative to tumor tissue following adjunctive administration of IFx-Hu2.0 in combination with pembrolizumab.

Appointment of Dr. Bertrand Le Bourdonnec as Head of Drug Discovery. In April 2025, TuHURA announced the appointment of Dr. Le Bourdonnec as the Company’s Executive Vice President, Head of Drug Discovery, Early Development and Program Management. Dr. Le Bourdonnec has extensive experience in the biology and molecular pharmacology of the DOR, TuHURA’s core target on MDSCs for the Company’s emerging suite of ADC and APC development candidates.

Appointment of Dr. Craig L. Tendler to Board of Directors. In March 2025, TuHURA announced the appointment of industry veteran Dr. Craig Tendler to its Board of Directors. Dr. Tendler brings to TuHURA decades of experience in cancer therapeutic development, and most recently served as Johnson & Johnson’s Vice President, Oncology Clinical Development. During his tenure at J&J, Dr. Tendler oversaw 30 major drug approvals, and led development planning from proof of concept through registration and life-cycle management, for J&J’s treatments in hematological malignancies and more prevalent solid tumor diseases.

Upcoming Anticipated Milestones by Program

7

IFx-Hu2.0

Q2 2025 : TuHURA anticipates the FDA’s complete response letter