TuHURA Biosciences, Inc.

TuHURA Biosciences Provides First Look at Data from its Open-Label Study of IFx-2.0 as an Adjunctive Therapy to Keytruda® in First Line Treatment of Patients with Deep Seated Metastatic Merkel Cell Carcinoma

TuHURA Biosciences reported initial data from the first three patients in its open-label Phase 1b/2a study of IFx-2.0 plus Keytruda in first-line metastatic Merkel Cell Carcinoma. All three patients achieved partial responses per RECIST v1.1, with every response ongoing at the protocol-specified six-month assessment, and CT/ultrasound-guided administration was shown to be safe and feasible in deep-seated bulky tumors. Management framed the results as a proxy for the ongoing randomized placebo-controlled Phase 3 trial and said it would explore expanding enrollment and discussing the data with the FDA if responses hold.

•6d ago

TuHURA Biosciences Receives FDA "Study May Proceed" Notice and IND Clearance for the Evaluation of its TBS-2025 VISTA-Inhibiting Antibody in Molecularly Defined Subsets of AML and Other Blood-Related Cancers

The FDA has issued a 'Study May Proceed' notice and cleared TuHURA Biosciences' IND application for TBS-2025, a VISTA-inhibiting antibody, for molecularly defined subsets of acute myeloid leukemia and other blood-related cancers. The clearance enables a Phase 1b study of TBS-2025 monotherapy in relapsed/refractory mutNPM1 AML patients who failed menin inhibitor therapy — a population with no approved treatments. If dose-optimization response rates are encouraging, TuHURA will discuss trial expansion with the FDA toward a potential accelerated approval. CEO Dr. James Bianco called it a major milestone, noting TuHURA is the only known company to advance a VISTA-inhibiting mAb through the IND process into a Phase 1b AML study; preclinical murine models showed TBS-2025 improved survival. TBS-2025 is TuHURA's second clinical pipeline asset behind IFx-2.0, which is in a Phase 3 registration trial as an adjunct to Keytruda in first-line advanced or metastatic Merkel Cell Carcinoma.

•1mo ago

TuHURA Biosciences Files Investigational New Drug Application for Evaluation of the TBS-2025 VISTA Inhibiting Antibody in Molecularly Defined Subsets of AML and Other Blood Related Cancers

TuHURA Biosciences filed an Investigational New Drug (IND) application with the FDA for TBS-2025, a VISTA-inhibiting antibody, targeting molecularly defined subsets of Acute Myeloid Leukemia (AML). The filing follows detailed FDA feedback on a previous submission, with the agency waiving a required meeting in favor of written responses to the proposed Phase 1b/2 development plan. The company targets initiating the combined Phase 1b/2 study in the second half of 2026, aiming to evaluate TBS-2025 as both monotherapy and in combination with menin inhibitors in patients with NPM1 mutations.

•4mo ago

TuHURA Biosciences Reports First Quarter 2026 Financial Results and Provides a Corporate Update

TuHURA Biosciences reported Q1 2026 results with $6.3 million in cash and $5.2 million in R&D expenses, maintaining a burn rate consistent with prior periods. The company secured a $50 million non-equity credit facility from its largest stockholder, extending its cash runway into 2028 and providing capital for clinical development without immediate dilution. Management highlighted upcoming milestones, including an FDA IND meeting for TBS-2025 in AML and the completion of enrollment in the Phase 3 IFx-2.0 trial for Merkel Cell Carcinoma in late 2027.

•5mo ago