Gyre Therapeutics' TuHURA Biosciences Advances Cancer Immunotherapy with IFx-2.0 Trial Progress

TuHURA Biosciences Advances Cancer Immunotherapy with IFx-2.0 Trial

TuHURA Biosciences, Inc. is making significant strides in the field of immune-oncology, particularly with its lead Phase 3 trial of IFx-2.0, an adjunct therapy designed to enhance the efficacy of Keytruda® (pembrolizumab) for patients suffering from advanced and metastatic Merkel cell carcinoma (MCC). The company anticipates completing enrollment for this pivotal trial by the fourth quarter of 2026, having secured a Special Protocol Assessment from the FDA. This regulatory endorsement marks a critical step in the development of IFx-2.0, which aims to provide a new treatment avenue for patients facing this aggressive form of skin cancer.

In addition to the IFx-2.0 trial, TuHURA is exploring the potential of targeting VISTA (V-domain Ig suppressor of T cell activation) in treating acute myeloid leukemia (AML), especially in cases that are relapsed or refractory due to NPM1 mutations. Insights shared during a Key Opinion Leader (KOL) symposium on December 5, 2025, underscore the promise of combining VISTA inhibition with menin inhibitors as a novel therapeutic strategy. This approach could significantly expand treatment options for AML, a disease characterized by high resistance to current therapies, thereby potentially improving patient outcomes.

The company also recently presented compelling data at the 57th ASH Annual Meeting, showcasing the Delta Opioid Receptor (DOR) as a promising target for its bi-functional, bi-specific immune modulating antibody drug conjugates (ADCs). Dr. James Bianco, TuHURA's President and CEO, describes 2025 as a transformative year for the company, marked by the initiation of the Phase 3 trial for IFx-2.0 and a strategic merger with Kineta, which has bolstered its pipeline with a Phase 2 ready VISTA inhibiting antibody. Looking forward, TuHURA aims to achieve key milestones in 2026, including FDA clearance for a randomized Phase 2 trial comparing a menin inhibitor with a combination therapy involving TBS-2025, the VISTA inhibiting antibody.

In a separate development, OpenBench, Inc. has partnered with Brii Biosciences Limited to leverage cutting-edge artificial intelligence for molecular discovery. The collaboration aims to enhance Brii Bio's therapeutic initiatives, particularly in addressing unmet medical needs. This strategic alliance is expected to improve the efficiency of drug discovery, ultimately contributing to the development of therapies for diseases with significant treatment gaps, such as hepatitis B virus (HBV).