TuHURA Biosciences and Kintara Therapeutics Complete Merger, Focus on Novel Immunotherapies
Key Insights
TuHURA Biosciences (search) and Kintara Therapeutics have finalized their merger, creating a combined entity named TuHURA Biosciences, Inc., focused on advancing cancer immunotherapies.
The merged company will prioritize TuHURA's technologies, including innate immune response agonists and tumor microenvironment modulators, to combat resistance to cancer immunotherapy.
TuHURA plans to initiate a Phase 3 trial in H1 2025 for IFx-2.0, an innate immune response agonist, as an adjunctive therapy to Keytruda in advanced Merkel Cell Carcinoma (search).
TuHURA Biosciences (search), an immune-oncology company specializing in overcoming resistance to cancer immunotherapy, has completed its merger with Kintara Therapeutics. The combined company will operate as TuHURA Biosciences, Inc., focusing on advancing TuHURA's novel technologies.
Strategic Focus on Overcoming Immunotherapy Resistance
The newly formed TuHURA Biosciences (search) will concentrate on its two core technology platforms: Immune Fx (IFx) Innate Immune Response Agonists and Tumor Microenvironment Modulators. These technologies aim to address the primary obstacles limiting the effectiveness of current immunotherapies in cancer treatment.
"This marks a transformational milestone for both companies and is a significant step in the evolution of TuHURA," said Dr. James Bianco, president and CEO of TuHURA. "Our novel technologies are designed to overcome resistance to cancer immunotherapy, and we are planning to initiate a single phase 3 accelerated approval registration trial in the first half of 2025 with our lead innate immune response agonist, IFx-2.0."
Phase 3 Trial Planned for IFx-2.0 in Merkel Cell Carcinoma
TuHURA is preparing to initiate a Phase 3 accelerated approval 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 (search). This trial is under a Special Protocol Assessment (SPA) agreement with the US FDA and is expected to begin in the first half of 2025. IFx-2.0 utilizes a proprietary plasmid DNA (pDNA) or messenger RNA (mRNA) to express a highly immunogenic bacterial protein (Emm55) on the surface of tumor cells, designed to overcome primary resistance to checkpoint inhibitors.
Targeting the Tumor Microenvironment
In addition to IFx-2.0, TuHURA is developing bi-specific immune modulating Antibody (ADC) or Peptide (PDC) Drug Conjugates targeting Myeloid Derived Suppressor Cells (search) (MDSCs). These Tumor Microenvironment Modulators leverage TuHURA's Delta receptor technology to inhibit the immune-suppressing effects of MDSCs, aiming to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
Merger Details and Leadership
Under the merger agreement, Kintara’s wholly-owned subsidiary, Kayak Mergeco, Inc., merged with and into TuHURA, with TuHURA surviving as the combined company’s direct, wholly-owned subsidiary. Post-merger, former Kintara equity holders own approximately 2.85% (or approximately 5.45% after giving effect to the shares issued pursuant to the CVR Agreement if the milestones are achieved) of the common stock of the combined company on a pro forma fully diluted basis, while TuHURA equity holders own approximately 97.15% (or approximately 94.55% after giving effect to the shares issued pursuant to the CVR agreement if the milestones are achieved).
The combined company will continue to be led by James Bianco as president and chief executive officer, with Dan Dearborn as CFO and Dennis Yamashita as chief scientific officer.