Company: HURA
Filing Date: 2025-04-28
Form Type: 425
Source: 0000950170-25-058970
Chunk: 1

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-04-28
Form: 425
Chunk 1
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, including:

At 1,000mg every two weeks, KVA12123 demonstrated greater than dose proportional PK profile exceeding 90% VISTA receptor occupancy, providing important PK data for determining recommended Phase 2 dose.

No dose limiting toxicities were observed in the study, including at the 1,000mg dose level, among the 24 patients treated in the monotherapy or in the 17 patients in the combination with pembrolizumab arms

“We are pleased to have Thierry present the latest data from the KVA12123 program, a valuable drug candidate that TuHURA will acquire following the closure of the proposed merger with Kineta which is currently targeted for the end of Q2 2025. TuHURA’s exclusivity payment last July allowed Kineta the ability to restart and complete the Phase I study providing important data regarding receptor occupancy and other PK, PD and translational biomarker data at the previously unstudied 1,000mg dose level. The study demonstrated in excess of 90% VISTA receptor occupancy over the entire Q2W dosing interval where PK simulations would predict similar receptor occupancy even at 750mg Q2W dosing, which we believe will be the recommended Phase 2 dose and schedule”, stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences.

Dr. Bianco continued, “Our primary interest in VISTA is its potential in immunologic tolerance in a variety of blood related cancers. Recent scientific data demonstrates that NPM1 mutation, present in 30% to 35% of patients with acute myeloid leukemia (AML) results in the high expression of VISTA on leukemic blasts. This is believed to be the mechanism by which leukemia escapes immune recognition and attack and is responsible for high rate of treatment failures in AML. We look forward to evaluating the VISTA inhibiting antibody in a Phase 2 randomized study in relapsed AML, which we expect to initiate in the fourth quarter of 2025 based on the anticipated closing of the proposed merger with Kineta.”

TuHURA also announced that the Markowitz Lab at Moffitt Cancer Center also presented a poster of TuHURA’s IFx-Hu2.0 in patients with advanced treatment refractory Melanoma who, like patients in TuHURA’s Phase 1b Merkel cell carcinoma trial, progressed while on CPI therapy. The data demonstrated that, among heavily pre-treated patients with advanced Melanoma who were resistant to anti-PD