On April 28, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported on poster presentations of Kineta Inc.’s ("Kineta") KVA12123 novel anti-VISTA antibody and TuHURA’s IFx-Hu2.0 in advanced melanoma and at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL (Press release, TuHURA Biosciences, APR 28, 2025, View Source [SID1234652249]).
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In the first poster presentation, (CT041/20) TuHURA and Kineta provided updated results from VISTA-101, a Phase I-II first-in-human study of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors (NCT05708950). The poster, was presented by Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. KVA12123 was found to be generally safe and well tolerated in all monotherapy and combination arms, with no dose-limiting toxicities observed. Additionally, KVA12123 demonstrated a favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile at all dose levels, including:
At 1,000mg every two weeks, KVA12123 demonstrated greater than dose proportional PK profile exceeding 90% VISTA receptor occupancy, providing important PK data for determining recommended Phase 2 dose.
No dose limiting toxicities were observed in the study, including at the 1,000mg dose level, among the 24 patients treated in the monotherapy or in the 17 patients in the combination with pembrolizumab arms
"We are pleased to have Thierry present the latest data from the KVA12123 program, a valuable drug candidate that TuHURA will acquire following the closure of the proposed merger with Kineta which is currently targeted for the end of Q2 2025. TuHURA’s exclusivity payment last July allowed Kineta the ability to restart and complete the Phase I study providing important data regarding receptor occupancy and other PK, PD and translational biomarker data at the previously unstudied 1,000mg dose level. The study demonstrated in excess of 90% VISTA receptor occupancy over the entire Q2W dosing interval where PK simulations would predict similar receptor occupancy even at 750mg Q2W dosing, which we believe will be the recommended Phase 2 dose and schedule", stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences.
Dr. Bianco continued, "Our primary interest in VISTA is its potential in immunologic tolerance in a variety of blood related cancers. Recent scientific data demonstrates that NPM1 mutation, present in 30% to 35% of patients with acute myeloid leukemia (AML) results in the high expression of VISTA on leukemic blasts. This is believed to be the mechanism by which leukemia escapes immune recognition and attack and is responsible for high rate of treatment failures in AML. We look forward to evaluating the VISTA inhibiting antibody in a Phase 2 randomized study in relapsed AML, which we expect to initiate in the fourth quarter of 2025 based on the anticipated closing of the proposed merger with Kineta."
TuHURA also announced that the Markowitz Lab at Moffitt Cancer Center also presented a poster of TuHURA’s IFx-Hu2.0 in patients with advanced treatment refractory Melanoma who, like patients in TuHURA’s Phase 1b Merkel cell carcinoma trial, progressed while on CPI therapy. The data demonstrated that, among heavily pre-treated patients with advanced Melanoma who were resistant to anti-PD-1-based therapy, following IFx-Hu2.0, three of four patients achieved clinically meaningful, durable anti-tumor responses following re-administration of a CPI.
"Demonstration of the development of antibody specific response to the Emm55 bacterial protein expressed on the surface of the tumor cell following IFx-Hu2.0 in the phase 1 study and an abscopal effect in murine model of melanoma is consistent with the data generated in patients with advanced cutaneous malignancies like melanoma or Merkel cell carcinoma," noted Dr. Bianco. "We look forward to that anticipated initiation of our Phase 3 accelerated approval trial in first line treatment of patients with advanced or metastatic Merkel cell carcinoma targeted for later this quarter."
In the second poster presentation relating to IFx-Hu2.0 entitled: "Mechanistic Insights into IFx- Hu2.0 Responses in the First Human Trial After Prior Anti-PD-1 Therapy Failure," (3428/23) IFx-Hu2.0’s first-in-human study demonstrated stimulation of an innate immune response, with increased T cell and B cell production in peripheral blood compared to tumor tissue. This innate immune activation underscores the potential of IFx-Hu2.0 to generate tumor specific activate T and B cells for patients who are resistant to anti-PD-1 CPIs. Additionally, IFx-Hu2.0 was generally safe and well tolerated, with only mild Grade 1 and Grade 2 adverse events, largely injection site reactions.
As previously announced, on December 11, 2024, TuHURA entered into a definitive agreement with Kineta, Inc. (OTC Pink: KANT) ("Kineta"), in which TuHURA agreed to acquire Kineta, including the rights to Kineta’s novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction upon the terms and conditions and subject to the conditions set forth in TuHURA’s Form 8-K filed on December 12, 2024. The merger is currently targeted to close in Q2 2025 pending the satisfaction of certain closing conditions.