Company: HURA
Filing Date: 2025-05-15
Form Type: 425
Source: 0000950170-25-072703
Chunk: 5

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-15
Form: 425
Chunk 5
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 will include patients without skin lesions who present with metastatic deep-seated tumors in the liver, lungs or retroperitoneum (abdomen), who are not eligible to participate in our Phase 3 accelerated approval trial due to the trial’s primary lesion enrollment criteria. Approximately 30% of MCC patients have unknown primary lesions, and demonstrating safety and efficacy in the MCCUP patient population would allow us the opportunity to provide IFx-Hu2.0 to more patients with MCC,” said James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. “We are also moving towards initiating our Phase 3 accelerated approval trial of IFx-Hu2.0 in first-line advanced and metastatic MCC and anticipate resolving the manufacturing-related partial clinical hold in the coming weeks. Our Phase 3 trial, for which we have an SPA agreement with the FDA, will be a single randomized placebo-controlled trial, and, if positive, may satisfy the requirement for a post-approval confirmatory trial, saving time, money and risk associated with a second trial.”

“In addition to our IFx-Hu2.0 drug candidate, we continue to assemble an exciting late-stage pipeline through our pending acquisition of Kineta, Inc. and its VISTA inhibitor antibody, KVA12123. We are targeting to close the acquisition later this quarter subject to financing and other conditions and advance KVA12123 into a Phase 2 trial in relapsed or refractoryNPM1-mutated AML where VISTA expression on leukemic blasts is believed to be responsible for how leukemic cells escape immune recognition contributing to poor responses to therapy and high

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rates of relapse,” stated Dr. Bianco. “We are also developing tumor microenvironment modulators in the form of bi-specific immune modulating Antibody Peptide Conjugates (APCs) and Antibody Drug Conjugates (ADCs) targeting myeloid-derived suppressor cells (MDSCs). We plan to present additional data at a scientific conference this year on the discovery of high-expression delta opioid receptor (DOR) and the effect on MDSCs and M2 macrophages in the tumor environment. We believe that our DOR program has the potential to reprogram the function of MDSCs and M2 macrophages within the tumor microenvironment, which could have broad implications,” concluded Dr. Bianco.

Corporate Highlights

Initiation of Phase 1b/2a Study of IFx-Hu2.0 as Adj