Company: HURA
Filing Date: 2025-02-07
Form Type: S-4
Source: 0001193125-25-022803
Chunk: 411

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-02-07
Form: S-4
Chunk 411
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 molecule to the inhibit the DOR on tumor associated MDSCs , and a checkpoint inhibitor targeting checkpoints on T cells or other immune cells.

These bi-specific conjugates are also bi-functional: inhibition of DOR decreasing their immune suppression, on TME making tumor more susceptible to attack to checkpoint released activated tumor specific T cells. In addition to modulating the immunosuppressive phenotype of the TME, TuHURA’s APCs through DOR inhibition block many of the elements associated with tumor malignant phenotype, most notably the ability to invade and metastasize. These two functions are intended to work together with the goal of overcoming acquired resistance, preventing T cell exhaustion and allowing checkpoint inhibitors and cellular therapies to be safer and more effective while interfering with the tumor’s ability to invade and spread throughout the body.

Our Pipeline

Our pipeline focuses on acquiring and developing technologies designed to overcome tumor-intrinsic mechanisms underlying primary resistance to checkpoint inhibitors. We also focus on technologies to overcome acquired resistance to cancer immunotherapies related to the immune suppressing characteristics of the TME. We are leveraging our technology platforms to advance several diversified product candidates, including principally the following:

IFx-2.Innate Immune Agonist. IFx-2.0 is our lead product candidate. We received guidance from and worked with the FDA’s Office of Tissues and Advanced Therapies and Oncology Center of Excellence in developing the Phase 3 trial for IFx-2.0. For a description of the planned Phase 3 trial, see “Information about TuHURA’s Business—TuHURA’s Clinical Development Program—Planned Phase 3 Trial for IFx-2.0.”

IFx-2.0Phase 1b/2a Basket Trial.We are planning 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**

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**common biologic reason for resistance to checkpoint inhibitors. The phase 1b stage of the trial will examine the feasibility and safety of Keytruda and adjunctive IFx-2.0 where IFx-2.0 is 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. The Phase 2a stage of the trial will include patients with checkpoint inhibitor resistant ovarian and triple negative breast cancer or