On June 30, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported the successful completion of the acquisition of Kineta, Inc. (OTCPK:KANT) ("Kineta"), the maker of the novel VISTA inhibiting mAb formerly known as KVA1213, now renamed as TBS-2025 (Press release, TuHURA Biosciences, JUN 30, 2025, View Source [SID1234654173]).
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"While TuHURA’s IFx-2.0 is being investigated for its potential to overcome primary resistance to checkpoint inhibitors in Merkel cell carcinoma, the acquisition of VISTA expands TuHURA’s pipeline with a Phase 2 ready drug candidate, TBS-2025, which TuHURA believes has the potential to overcome acquired resistance to cancer immunotherapy," stated James Bianco, M.D., President and Chief Executive Officer of TuHURA. "The acquisition provides for synergies across both TuHURA’s therapeutic focus as well as with TuHURA’s antibody drug conjugate (ADC) technology. Not only can TBS-2025 be administered as the intact mAb alone or in combination with other therapeutics, we are also investigating the possibility of it being conjugated to a Delta Opioid Receptor inhibitor(s) resulting in a potential immunomodulatory, bi-functional, and bi-specific ADC targeting myeloid derived suppressor cells (MDSCs) in the tumor microenvironment (TME)."
"We are currently planning on investigating TBS-2025 (formerly known as KVA12123) in a Phase 2 trial in combination with a menin inhibitor in NPM1 mutated AML. 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. Research has demonstrated that when mutated, NPM1 and DNM3TA, two of the most common mutations in AML and typically co-mutated in myelodysplasia (MDS), result in high expression of VISTA on the surface of leukemic blasts. The presence of VISTA on these cells is believed to be the primary mechanism by which leukemic cells escape immune recognition and attack, resulting in a low treatment response rate and a high level of relapse in AML. We believe, in a relatively inexpensive, small Phase 2 study, we can determine if TBS-2025, our VISTA inhibiting antibody, can augment the response rates seen with menin inhibitors and decrease the rate of relapse in patients with NMP1 mutated relapsed or refractory AML where menin inhibitors are the current standard of care."
About the Transaction
Pursuant to the terms and conditions of the merger agreement between TuHURA and Kineta, each share of Kineta common stock, par value $0.001 per share (each, a "Share"), issued and outstanding immediately prior to the merger, was converted into the right to receive at the closing of the merger 0.185298 shares of TuHURA common stock, par value $0.001 per share ("TuHURA Common Stock"), for an aggregate of 2,868,169 shares of TuHURA Common Stock. Also pursuant to the terms and conditions of the merger agreement, each Share is also entitled to its pro rata portion of an aggregate of 1,129,885 additional shares of TuHURA Common Stock to be issued after 6 months following the closing, which aggregate number of shares is subject to adjustment for losses incurred or accrued during the six month period from the closing of the merger, and (ii) the right to its pro rata share of cash consideration received by Kineta pursuant to disposed asset payments related to legacy Kineta assets. Such payments of cash consideration, if any, will be made at a later date and in accordance with the terms of the merger agreement. In each case, in lieu of the issuance of a fractional share of TuHURA Common Stock to former holders of Kineta common stock, TuHURA will pay an amount equal to the product of (A) such fractional share and (B) $5.7528.
Leerink Partners acted as the exclusive financial advisor to TuHURA on the transaction.
About TBS-2025 (f/k/a KVA12123)
VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells. VISTA is a strong driver of immunosuppression in the tumor microenvironment (TME). VISTA expression is found on infiltrating immune cells, with the highest levels on myeloid lineage cells, including MDSCs. It suppresses T cell function, and high levels of VISTA expression in the human TME have been correlated in most studies with decreased overall survival (OS).
TBS-2025 VISTA-blocking immunotherapy is administered intravenously every 2 weeks (Iadonato et al. Front Immunol 2023). It is an engineered IgG1 mAb with an extended half-life that binds to a unique epitope at both acidic and neutral pH.
TBS-2025 was investigated in a dose escalation Phase 1/2 trial, both as a monotherapy and in combination with pembrolizumab, in patients with relapsed and/or treatment-refractory advanced solid tumors. TBS-2025 was well tolerated at doses up to 1,000mg both in the monotherapy arm (n=24) or in the pembrolizumab combination therapy arm (n=16). Pharmacokinetic and pharmacodynamic data demonstrated greater than 90% receptor occupancy across the every two- week dosing interval. Immunocytokine analysis was consistent with the mechanism of action for VISTA inhibition on immune cells.