Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 428

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 428
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0 to the 30% - 35% of patients with advanced or metastatic Merkel cell carcinoma who do not present with cutaneous or lymph nodal lesions by examining the safety and efficacy of IFx-2.0 in first line treatment as adjunctive therapy to Keytruda® when administered via interventional radiology to lesion in the liver, lung or retroperitoneal. Once we determine feasibility and safety when IFx-2.0 is administered this way, we plan on a second stage of this study open to other cancers beyond Merkel cell carcinoma by conducting the basket trial described above. We plan on examining IFx-2.0 in patients with any type of advanced cancer where their tumor exhibits primary resistance to and who fail checkpoint inhibitor therapy. If successful, this basket trial is intended to potentially expand the use of IFx-2.0 to many types of cancer for which there are no effective or approved therapies for patients who fail to respond to checkpoint inhibitors or whose cancers are known not to respond to checkpoint inhibitors. |

| • |     | Leverage the IFx technology platform to develop next generation candidates to expand into hematologic cancer indications. We are also developing IFx-3.0, its mRNA based innate immune agonist candidate, for systemic (intravenous) or autologous whole cell administration targeting the CD22 receptor on malignant B cells as a potential treatment for blood related cancers like aggressive lymphoma, with the intention of expanding the application of IFx technology to blood related cancers not amenable to intratumoral administration. The Company believes this would be the first systemically targeted mRNA innate immune agonist known to be in development. |

| • |     | Establish a leadership position in developing immune modulating bi-functional ADCs and APCs. We believe that we may be the first company to identify a novel Delta Opioid Receptor that controls the regulation of multiple immune suppressive functions of MDSCs, the primary contributor to tumor microenvironment immunosuppression. The Company believes that inhibiting MDSC functionality may represent a novel way to overcome acquired resistance to immunotherapies. The Company believes that its immune modulating bi-specific bi-functional ADCs and APCs represent a paradigm shift in this important class of therapeutics and has the potential to position the Company to take the lead on advancing these novel immunomodulatory bi-functional ADCs and APCs to clinical trials. |

| • |     | Establish Development and Commercial License Collaborations. Leveraging our CEO’s track record of successfully establishing development