Company: HURA
Filing Date: 2025-02-07
Form Type: S-4
Source: 0001193125-25-022803
Chunk: 431

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-02-07
Form: S-4
Chunk 431
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 extension of the company’s innate immune agonist candidates to tumors not accessible by injection, like blood-related cancers, and could result in eliciting a more potent immune response without the need for checkpoint inhibitors. We expect to develop an anti-CD22 conjugated mRNA LNP candidate forin vitro andin vivo characterization and select a lead candidate and initiate IND-enabling studies in 2 half 2025.

Market Opportunity

Checkpoint inhibitors dominate oncology sales and represent the most successful oncology drug commercial launches in oncology drug development. Since their commercial launch in 2014, sales of checkpoint inhibitors have grown at an impressive compounded annual growth rate with $29.9 billion in sales in 2020 reaching $37 billion in 2022, according to Precedence Research. By 2030 the market is expected to grow to over $148 billion in world wide sales, according to Precedence Research. The company believes that its technology platforms have the potential to address both primary and acquired resistance, the two major limitations to checkpoint inhibitor and cellular therapies and as such represents a large market opportunity. While upward of 15% to 60% of patients will respond to first time treatment with checkpoint inhibitors, 40% to 85% will not. It is this population of patients with primary resistance to checkpoint inhibitors that the company believes represents the initial market opportunity for IFx-2.0. The biologic basis for primary resistance to checkpoint inhibitors is similar across various tumor types, predominately the lack of tumor infiltration with activated tumor specific T cells. The company believes that an agent that can overcome primary resistance to checkpoint inhibitors in one tumor type should overcome resistance in others, if not all, tumor types that exhibit primary resistance to them. The company’s initial strategy is to demonstrate the ability of IFx-2.0 to overcome primary resistance in the 50%**

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**of patients with advanced MCC receiving front line therapy with Keytruda (pembrolizumab), the current standard of care, allowing more patients to achieve an anti-tumor response than with Keytruda alone.

It is estimated by the American Cancer Society that there are approximately 3,3000 patients in the U.S. diagnosed with MCC each year with approximately 4,500 in Australia and 7 major market countries in the EU. The standard of care for patients with the advanced or metastatic MCC is therapy with a checkpoint inhibitor like Keytruda (pembrolizumab). The company also plans on