Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 546

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 546
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 monotherapy in the VISTA-101 trial in
April 2023. The ongoing Phase 1/2 clinical study of KVA12123 has finished enrollment in the monotherapy cohorts and continues enrollment in the last combination cohorts with pembrolizumab.

VISTA-101 is a
first-in-human (FIH), Phase 1/2, open-label, multicenter, dose escalation, and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics
(“PK”), immunogenicity, and tumor response of the investigational drug KVA12123 as a monotherapy and in combination with pembrolizumab in adults with relapsed or refractory advanced solid tumors.

The study is being conducted in 4 parts: Parts A, B, C and D. Parts A and B focus on dose escalation. Parts A (single-agent KVA12123) and B
(KVA12123 + pembrolizumab) comprise up to 6 and 4 dose escalation cohorts, respectively, each treating 1-6 participants, to characterize the safety, tolerability, pharmacodynamics (“PD”), PK and
preliminary tumor responses of study interventions.

Parts C and D will focus on dose expansion. Parts C (single-agent KVA12123) and D
(KVA12123 + pembrolizumab) will comprise up to 7 disease-specific dose expansion cohorts (2 for Part C and 5 for Part D), which will commence at the recommended Phase 2 dose (“RP2D”) to further characterize the safety, tolerability, PD,
PK, and preliminary tumor response of KVA12123 as a monotherapy and in combination with

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pembrolizumab. Part C and Part D will enroll patients with specific tumor types including NSCLC, SCCHN, OC, CRC and RCC as determined in Parts A and B. Figure 13.KVA12123 Phase 1/Phase 2 dose escalation study design VISTA-101study objectives VISTA-101study objectives are outlined below: Primary objectives

| • |     | Safety and tolerability |

| • |     | Recommended Phase 2 dose or maximum tolerated dose of KVA12123 |

Secondary objectives

| • |     | Pharmacokinetics |

| • |     | Immunogenicity |

| • |     | Tumor response in subjects with advanced solid tumors per iRECIST (ORR) |

Exploratory Objectives

| • |     | Biom