TuHURA Biosciences: Unlocking Cancer Immunotherapy's Full Potential

TuHURA Biosciences, Inc. (Nasdaq:HURA) has made significant strides in its mission to overcome resistance to cancer immunotherapy, as it provided a business update and outlined upcoming targeted milestones. The company, now a Phase 3 registration-stage immune-oncology firm, is poised to revolutionize the field with its novel technologies.

TuHURA's lead program, IFx-2.0, is entering a single Phase 3 accelerated approval registration trial in the first half of 2025 for the treatment of 1st line Merkel Cell carcinoma. This trial comes under a Special Protocol Assessment (SPA) agreement with the FDA, ensuring a well-aligned trial design and increasing the likelihood of success. The trial will investigate IFx-2.0 in combination with Keytruda® (pembrolizumab), potentially overcoming primary resistance to checkpoint inhibitors.



TuHURA is also expanding its pipeline through a non-binding letter of intent with Kineta, exploring the potential acquisition of KVA12123, a Phase 2 ready, novel VISTA inhibiting antibody. This acquisition would bring a complementary therapy to TuHURA's pipeline, enhancing its therapeutic synergies and reducing development timelines.

Moreover, TuHURA is advancing IFx-3.0, the first systemically administered tumor-targeted mRNA innate immune response agonist for aggressive B Cell Lymphoma. Additionally, the company is developing early discovery programs for first-in-class tumor microenvironment modulating bi-specific antibody drug conjugates (ADCs) or peptide drug conjugates (PDCs) targeting Myeloid Derived Suppressor Cells (MDSCs).



The company has secured $31 million in financing through a merger with Kintara, funding operations into late 2025. This capital raise, combined with the potential acquisition of KVA12123, positions TuHURA to advance its pipeline and maintain a strong competitive stance in the immune-oncology landscape.

TuHURA's strategic initiatives, supported by robust financing and a promising pipeline, place it at the forefront of cancer immunotherapy. By addressing both primary and acquired resistance, the company aims to unlock the full potential of cancer immunotherapy, ultimately improving patient outcomes and transforming the field.