Core Insights - TuHURA Biosciences has filed an Investigational New Drug Application (IND) for TBS-2025, a novel VISTA inhibiting antibody, aimed at treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia (AML) in combination with a menin inhibitor [1] - The company plans to initiate a Phase 2 study in early Q2 2026, targeting menin inhibitor naïve patients, with preliminary results expected in Q3 2026 [1] - TBS-2025 is expected to address the unmet medical need in AML treatment, as current therapies have low complete response rates of less than 25% [1] Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to overcome resistance to cancer immunotherapy [1] - The company’s lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 trial for advanced Merkel Cell Carcinoma [1] - TBS-2025 was acquired through the merger with Kineta Inc. and is moving into Phase 2 development for mutNPM1 r/r AML [1] Scientific Rationale - Scientific evidence indicates that mutations like mutNPM1 drive VISTA expression on leukemic cells, contributing to poor therapy responses and high relapse rates in AML [1] - The removal of the VSIR gene, which encodes for VISTA, in murine models has shown enhanced immune response and improved survival rates [1] - TBS-2025 demonstrated a favorable safety profile in a Phase 1 trial, with an optimal Phase 2 dose anticipated to be 750mg every three weeks [1]

Core Insights - TuHURA Biosciences is advancing its Phase 3 program of IFx-2.0 as an adjunctive therapy with Keytruda® for advanced Merkel cell carcinoma, with enrollment completion targeted for Q4-2026 [1][13] - The company raised $15.6 million in a recent equity financing transaction, providing a cash runway to achieve key milestones across its development programs [1][2] - A mini KOL symposium highlighted the potential of targeting VISTA in acute myeloid leukemia (AML) and the combination with menin inhibitors for NPM1 mutated relapsed/refractory AML [1][3] Company Developments - The Phase 3 trial of IFx-2.0 has been initiated, marking a significant step in the company's strategy to address resistance to cancer immunotherapy [2][13] - The merger with Kineta has added a Phase 2 ready VISTA inhibiting antibody to the company's pipeline, enhancing its therapeutic offerings [2][14] - Preliminary data from the IFx-2.0 basket trial and insights on inhibiting Delta Opioid Receptor (DOR) are expected to be presented at scientific conferences in 2026 [3] Clinical Insights - VISTA is identified as the only checkpoint significantly upregulated in AML, particularly in high-risk subtypes, contributing to low response rates in patients treated with menin inhibitors [11] - The combination of TBS-2025 (VISTA inhibiting antibody) with menin inhibitors shows promise in improving survival outcomes in murine models of AML [11] - Key opinion leaders expressed enthusiasm for the potential of TBS-2025 in combination therapies for high-risk AML and patients unfit for intensive treatments [3][11]

Core Points - TuHURA Biosciences, Inc. has been added to the Russell 3000® Index and automatically included in the Russell 2000® Index as part of the 2025 annual reconstitution, effective June 27, 2025 [1][2] - The inclusion in the Russell indexes signifies the company's progress in its first year as a publicly traded entity and reflects its potential for continued development [2] - TuHURA is currently enrolling patients in a Phase 3 accelerated approval trial of its lead product IFx-2.0, which is being tested as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel cell carcinoma [2][11] - The company has also acquired a novel anti-VISTA antibody from Kineta, Inc. and plans to advance it into a Phase 2 clinical trial for treating NMPL1-mutated Acute Myeloid Leukemia [2] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing both primary and acquired resistance [10] - The company's lead product, IFx-2.0, is designed to enhance the effectiveness of checkpoint inhibitors [11] - TuHURA is also leveraging its Delta Opioid Receptor technology to create bi-specific antibody drug conjugates aimed at inhibiting immune suppression in the tumor microenvironment [12]