Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 542

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 542
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ology targets address either T cell or myeloid functions, VISTA has the potential to regulate both.

KVA12123 has
demonstrated activity on important innate and adaptive immune cells (Figure 4) present in the TME in preclinical assays (in vitro).

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Figure 4.Blocking VISTA with KVA12123 activates both innate and adaptive immune
cells

Additionally, KVA12123 drives an integrated innate and adaptive anti-tumor immune response in tumor models
like MB49 bladder tumor (ex vivo).

Figure 5. Blocking VISTA with KVA12123 drives anti-tumor responses in MB49 model

In preclinical models, KVA12123 has been observed to show strong single agent tumor growth inhibition in
poorly immunogenic “cold tumors” models and complementary tumor growth inhibition when dosed in combination with CPIs like PD-1 or CTLA-4 as shown in Figure 6
below. Studies in preclinical tumor models demonstrate the tumor growth inhibition of Kineta’s anti-VISTA antibody as a single agent in bladder cancer, T cell lymphoma and colon cancer models. In combination studies, Kineta’s anti-VISTA
antibody acts synergistically in combination with anti-PD-1 therapy to inhibit tumor growth in preclinical colon cancer and bladder cancer models.

350

Figure 6.KVA12123 demonstrates single agent tumor growth inhibition and in
combination with PD-1 in preclinical models

Source: Kineta data

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Kineta has completed multiple, single and repeat-dose toxicology studies in non-humanprimates (“NHP”) with doses of KVA12123 up to 100 mg/kg (>100-foldsafety margin over target human exposure). KVA12123 was observed to be well-tolerated in NHP toxicology studies with no mortality, no overt clinical signs or weight loss, no treatment-related findings and no change in CRS-associatedcytokine levels (IL6 or TNFα). IL6 and TNFα are indicators of CRS. KVA12123 Competitive Differentiation The competitive landscape for VISTA blocking immunotherapies includes four primary companies (Kineta, Inc., Hummingbird Bioscience Pte. Ltd., PharmAbcine, Inc. and Sensei Biotherapeutics, Inc.) with assets in Phase 1 clinical development. Other discovery stage assets have been announced by Apexigen, Inc. and Five Prime Therapeutics (acquired by Amgen Inc.)/Bristol Myers Squ