About Us | Overview

TuHURA
Biosciences

TuHURA Biosciences, Inc. (NASDAQ: HURA) is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA’s lead innate immune response agonist candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for advanced or metastatic Merkel Cell Carcinoma.

In addition to its innate immune response agonist candidates, TuHURA is leveraging its Delta receptor technology to develop first-in-class bi-specific ADCs, and PDCs targeting Myeloid Derived Suppressor Cells to inhibit their immune suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.

Our Strategy 

The company’s strategy leverages its technologies and novel product candidates as adjunctive therapy to overcome primary and acquired resistance to checkpoint inhibitors, molecularly modified immune therapies and cellular therapies. The key elements of this strategy include:

Shortening the time and cost to product registration

TuHURA is working to shorten the time and cost to product registration by focusing on patient populations that qualify for accelerated approval, such as patients with advanced Merkel Cell Carcinoma (MCC) working with FDA on novel trial design to preclude the need for a postmarketing required trial.

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Expanding the application of our IFx-2.0 personalized cancer vaccine

TuHURA believes that the tumor biology leading to primary resistance to checkpoint inhibitors, for the most part, shares the same mechanism irrespective of the type of tumor (i.e., histology agnostic). TuHURA plans 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 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 first time treatment with checkpoint inhibitors.

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Leverage the IFx technology platform to develop next generation candidates to expand into blood related cancers

TuHURA is also developing IFx-3.0, its mRNA based personalized cancer vaccine candidate, for systemic (intravenous) 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. TuHURA believes this would be the first systemically targeted mRNA cancer vaccine product candidate in development.

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Establish a leadership position in developing first-in-class Bi-Functional Antibody Drug Conjugates (ADCs)

TuHURA believes that it may be the first company to identify a novel Delta receptor that controls the regulation of multiple immune suppressive functions of MDSCs, the primary contributor to tumor microenvironment immunosuppression. TuHURA believes that inhibiting MDSC functionality may represent a novel way to overcome acquired resistance to immunotherapies. The company believes that its bi-functional ADCs 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 bi-functional ADCs to clinical trials.

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Establish development and commercial license collaborations

TuHURA intends to seek and establish partnerships with large pharmaceutical or biotech companies as a source of non-dilutive capital and funding to advance the global development of its product candidates.

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