Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 565

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 565
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 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

| • |     | Biomarker 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-101 clinical 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