Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 582

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 582
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-3to its canonical MHC Class II ligand. Since PD1, CTLA4 and LAG-3serve as breaks on the T-cell-drivenimmune response, antibodies that block these interactions enhance the activation of effector T cells. The first LAG-3inhibitor was FDA approved only in combination with a PD1 inhibitor in March 2022. Because there is such a large population of advanced cancer patients for whom there are few available treatments, the CPIs have become widely used, and this is reflected in the commercial success of the group. However, despite more than a decade of development, existing CPIs still address only two distinct mechanisms of action and are effective in only a fraction of treated patients. Several key CPI deficiencies have become apparent from the clinical data:

| • |     | CR rates for most tumor types, either as a single agent or in combination with other drugs, are low and sometimes similar to conventional chemotherapy. There are very few instances where CR rates exceed 10%. |

| • |     | Most patients have no response or PR and do not achieve durable remission of disease. There are few or no options for subsequent immunotherapy treatment of these patients. |

| • |     | Only a few CPI mechanisms are FDA approved, limiting combination therapy options. |

| • |     | CPIs are not labeled or show poor efficacy in the most frequent types of cancer, including breast cancer, NSCLC, prostate cancer and CRC. |

Because the key to successful cancer treatment often involves the use of complex combination therapies, the immuno-oncology field urgently needs additional immunotherapies that do not increase the burden of drug related toxicity. Kineta is developing novel immunotherapies that address the mechanisms of cancer resistance where current therapies fail. KVA12123 (VISTA) Competition There are currently no approved VISTA blocking immunotherapies on the market. The competitive landscape includes four primary companies with assets in Phase 1 clinical development (Figure 25). Other discovery stage assets have been announced by Apexigen, Inc. and Five Prime Therapeutics (acquired by Amgen Inc.)/BMS. 374

Figure 26.VISTA competitive landscape Other discovery stage programs: Apexigen and Five Prime Therapeutics/BMS. Anti-CD27 Agonist mAb Immunotherapy Competition The competitive landscape for anti-CD27 agonist immunotherapies is led by Merck & Co., Inc. and Celldex Therapeutics, Inc. Merck is developing an anti-