Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 547

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 547
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arker and receptor occupancy |

Clinical sites Kineta has engaged seven well-known research sites to conduct the Phase 1 arm of VISTA-101across the United States only (Figure 14). Three additional sites will be added as the study advances to the Phase 2 dose expansion cohorts. 358

Figure 14. VISTA-101clinical trial sites

Clinical collaboration with Merck

Kineta has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada). Under this
collaboration, Kineta will evaluate the safety, tolerability, PK and anti-tumor activity of KVA12123, its novel anti-VISTA monoclonal antibody, alone and in combination with KEYTRUDA
(pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced solid tumors.

Kineta is conducting a Phase 1/2 clinical study evaluating KVA12123 as a single agent and in combination with KEYTRUDA in patients with advanced solid tumors. The objectives of the study are to evaluate the safety, tolerability, PK and anti-tumor responses of KVA12123 as a monotherapy and in combination with
KEYTRUDA with initial clinical data released in the fourth quarter of 2023 and consolidated in the second and fourth quarters of 2024. Kineta is responsible for conducting this study.

VISTA-101Clinical Data

Kineta presented the last updated KVA12123 clinical data from VISTA-101 as a monotherapy and in
combination KEYTRUDA at the SITC 39 Annual Meeting in November 2024.

As of January 31, 2025, the Phase 1/2 VISTA-101 trial enrolled 24 patients with advanced solid
tumors in the six monotherapy dose-escalation cohorts, where subjects received either 3, 10, 30, 100, 300 or 1000 mg of KVA12123 by intravenous infusion every two weeks, and 13 patients in the first three combination therapy cohorts, where subjects
received 30, 100, and 300 mg of KVA12123 Q2W and 400 mg of pembrolizumab Q6W. Patients enrolled in VISTA-101 monotherapy arm ranged in gender, ethnicity and age (Figure 15). Patients were heavily pretreated
with multiple prior lines of therapy including chemotherapy, radiation and immunotherapy.

359

Figure 15. VISTA