Company: HURA
Filing Date: 2025-02-07
Form Type: S-4
Source: 0001193125-25-022803
Chunk: 533

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-02-07
Form: S-4
Chunk 533
---
 key biomarkers and immune cell populations are indicative of the anti-tumor effects of blocking VISTA that is consistent with data from preclinical models (NHP and KO mice). These data validate their use as potential biomarker of VISTA target engagement with KVA12123. VISTA-101Initial Monotherapy Data Summary Safety

| • |     | Cleared all six KVA12123 monotherapy cohorts (3, 10, 30, 100, 300 and 1000 mg KVA12123) and the first two combination therapy cohort (30 and 100 mg KVA12123 plus 400 mg pembrolizumab) with 33 patients dosed |

| • |     | Well tolerated and no DLT were observed |

| • |     | No evidence of CRS-associated cytokines (IL-6, TNFα and IL-10) were detected |

Pharmacokinetics (PK) and Receptor Occupancy (RO)

| • |     | KVA12123 administration achieved >90% VISTA RO at doses greater than or equal to 30 mg and a complete saturation of the target between two-dose interval was achieved at 1000 mg dose |

| • |     | PK analyses demonstrated a greater than dose-proportional increase in drug exposure across all evaluated doses, consistent with target-mediated drug disposition at lower doses and target saturation at higher doses |

Biomarkers

| • |     | Demonstrated efficacy-related cytokine secretion of CXCL10, IFNg, CCL2, CCL3, CCL4 and CXCL8 |

| • |     | Significant changes in anti-tumor immune cell subpopulations were observed after treatment |

**Development timeline The ongoing VISTA-101clinical trial is currently enrolling patients in the last two combination therapy cohorts of the study while full enrollment has been achieved in the monotherapy arm. Updated monotherapy and combination therapy data was presented at SITC in November 2024. Consolidated monotherapy and combination therapy safety and efficacy data are anticipated in the second quarter of 2025. Kineta anticipates a meeting with the FDA at the end of Phase 1 and expects to initiate the Phase 2 arms of VISTA-101in the second quarter of 2025. 342

Potentially Large Commercial Opportunity for KVA12123

Based on the strong clinical rationale and commercial opportunity, Kineta has identified NSCLC, SCCHN, OC, CRC and RCC as potential initial indications for KVA