Tampa, Florida-based TuHURA Biosciences has completed its acquisition of Kineta, Inc., adding a Phase 2-ready VISTA-inhibiting monoclonal antibody to its pipeline of cancer immunotherapy treatments designed to overcome resistance mechanisms that limit current therapies.
Key Points
- The Kineta acquisition brings TBS-2025, a VISTA-inhibiting monoclonal antibody, into TuHURA’s immuno-oncology pipeline with Phase 2 trials planned for the second half of 2025.
- The company aims to investigate the antibody in combination with a menin inhibitor for treating NPM1 mutated acute myeloid leukemia.
- VISTA (V-domain Ig suppressor of T cell activation) represents a different approach to checkpoint inhibition, being predominantly expressed on myeloid cells and quiescent T cells rather than activated T cells.
- VISTA is a strong driver of immunosuppression in the tumor microenvironment and is highly expressed on myeloid cells including MDSCs.
- The acquisition expands TuHURA’s strategy to address both primary and acquired resistance to cancer immunotherapy.
- While the company’s lead candidate IFx-2.0 targets primary resistance in a Phase 3 trial for Merkel Cell Carcinoma, TBS-2025 aims to overcome acquired resistance mechanisms.
- TuHURA plans to explore combining TBS-2025 with its antibody drug conjugate technology, potentially creating a bi-functional, bi-specific ADC targeting myeloid derived suppressor cells in the tumor microenvironment.
The acquisition positions TuHURA to address both primary and acquired resistance to cancer immunotherapy, targeting two key reasons why these treatments fail or stop working in cancer patients.
The Data
- Phase 1/2 trial of TBS-2025 in patients with relapsed/refractory advanced solid tumors included 24 patients in the monotherapy arm and 16 in the pembrolizumab combination arm.
- TBS-2025 demonstrated tolerability at doses up to 1,000mg with >90% receptor occupancy maintained across the every-two-week intravenous dosing interval.
- Kineta shareholders received 0.185298 shares of TuHURA stock per Kineta share, totaling 2,868,169 shares immediately, with an additional 1,129,885 shares to be issued after 6 months (subject to adjustment).
- The completed acquisition triggers the fourth tranche of a $12.5 million PIPE financing announced June 3, 2025.
Industry Context
Unlike other checkpoints, which are mostly present on activated T cells, VISTA is predominately expressed on myeloid cells, notably MDSCs, and on quiescent T cells.
James Bianco, M.D., President and CEO of TuHURA
The acquisition addresses a specific mechanism of cancer treatment resistance through VISTA inhibition. According to the company, certain common mutations in AML result in high VISTA expression on leukemic blast cells. This VISTA expression is believed to be the primary mechanism allowing these cancer cells to escape immune recognition and attack, contributing to low treatment response rates and high relapse rates in AML.
TBS-2025 is an engineered IgG1 monoclonal antibody with an extended half-life that binds to a unique epitope at both acidic and neutral pH levels. The company believes that in a relatively small Phase 2 study, it can determine whether VISTA inhibition can augment response rates to menin inhibitors and potentially decrease relapse rates in relapsed or refractory AML.
