Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 550

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 550
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 were observed during treatment (Figure 20).

Figure 20. VISTA-101KVA12123 pro-inflammatorybiomarkers

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Figure 21. VISTA-101KVA12123 immune cell responses KVA12123 demonstrated induction of pro-inflammatorymyeloid derived cytokines/chemokines involved in immune cell activation and recruitment in the TME. Changes in these 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 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