Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 569

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 569
---
 |     | Cleared all six KVA12123 monotherapy cohorts (3, 10, 30, 100, 300 and 1000 mg KVA12123) and completed enrollment of first three combination therapy cohort (30, 100 and 300 mg KVA12123 plus 400 mg pembrolizumab) with 37 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 In the ongoing VISTA-101clinical trial, full enrollment has been achieved in the monotherapy arm as well as in the first three combination therapy cohorts. The last combination therapy cohort opened in February 2025. 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 half of 2025. 364

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 KVA12123. Data from the Phase 1/2 clinical trial will more fully inform the indications to initially pursue for regulatory approval.

The projected new annual patients worldwide for each of these initial indications in 2027 totals 984,000 for NSCLC, 243,