Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 425

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 425
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 Phase 3 Trial for IFx-2.0.” IFx-2.0Phase 1b/2a Basket Trial .We have initiated a Phase 1b/2a trial referred to as a “basket” trial, which is a type of clinical trial that tests a new product candidate in patients who have different types of cancer but common biologic reason for resistance to checkpoint inhibitors. Approximately 30% to 35% of patients with advanced Merkel cell carcinoma do not present with cutaneous or nodal lesions and are therefore not eligible for participation in our Phase 3 study. In the first stage of this basket study, IFx-2.0 will be administered via interventional radiology into lesions in the liver, retroperitoneum or lungs of patients who have advanced and metastatic Merkel cell carcinoma who are checkpoint inhibitor naïve. who accessible cutaneous or lymph nodes. This trial has the potential to extend the application of IFx-2.0. The Phase 2a stage of the trial will include patients with checkpoint inhibitor resistant cancers such as triple negative breast cancer or other cancers known not to respond to checkpoint inhibitor therapy. We initiated this study in May of 2025. If successful, this trial could expand the utility of IFx-2.0beyond advanced Merkel cell carcinoma. IFx-3.0. IFx-3.0is our mRNA innate immune agonist for intravenous or autologous whole cell administration. We believe that advancing an mRNA innate immune agonist candidate for systemic or autologous whole cell administration may allow our company to expand the utility of its innate immune agonist technology to blood-related cancers, which are not amenable to intratumoral administration. The first planned application of IFx-3.0,is to target the CD22 receptor, which is over expressed on a number of B cell cancers like aggressive lymphomas. We plan to test various constructs in vitrobefore advancing to humanized immune competent murine models of aggressive lymphoma planned for 2026.

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Antibody drug or Peptide conjugates.We are also developing novel immune modulating bifunctional ADCs and APCs to modulate the tumor microenvironment by reprograming MDSCs’ immune suppressing capabilities through inhibition of the Delta Opioid Receptor on MDSCs while localizing checkpoint inhibitors to checkpoint release activated T cells in the tissue where the tumor resides. TuHURA is working on developing and expanding a portfolio of novel Delta specific small molecule or peptidom