KVA12123 shows promise in VISTA-101 trial

TAMPA, Fla. - TuHURA Biosciences, Inc. (NASDAQ:HURA), currently trading at $0.21 and down nearly 70% over the past six months, has shared new clinical data from the VISTA-101 trial of Kineta Inc.’s novel anti-VISTA antibody KVA12123, demonstrating significant receptor occupancy, and the efficacy of TuHURA’s IFx-Hu2.0 in advanced melanoma post-checkpoint inhibitor therapy failure. The findings were presented at the American Association for Cancer Research (AACR) Annual Meeting. According to InvestingPro analysis, the company’s stock shows high price volatility, with 11 additional key insights available to subscribers.

The VISTA-101 trial, a Phase I-II study (NCT05708950), evaluated KVA12123 alone and combined with pembrolizumab in patients with advanced solid tumors. The trial showed KVA12123 was safe and well-tolerated at all dose levels, with no dose-limiting toxicities. Notably, at a 1,000mg dose administered bi-weekly, the drug maintained over 90% VISTA receptor occupancy throughout the dosing interval, aiding in determining the recommended Phase 2 dose.

James Bianco, M.D., President and CEO of TuHURA, expressed optimism about the potential of VISTA in treating blood-related cancers, citing its role in immune tolerance. He highlighted the high expression of VISTA on leukemic blasts due to NPM1 mutation in acute myeloid leukemia (AML) patients as a mechanism for immune evasion and treatment failure. A Phase 2 randomized study in relapsed AML is expected to commence in the fourth quarter of 2025, pending the closure of TuHURA’s proposed merger with Kineta. With a current market capitalization of just $2.59 million and negative EBITDA of $13.52 million, InvestingPro data suggests the company is currently undervalued, though operating with significant financial challenges.

TuHURA also announced results from a study of IFx-Hu2.0 in advanced melanoma patients who had progressed on checkpoint inhibitor (CPI) therapy. The study showed clinically meaningful anti-tumor responses and an abscopal effect after re-administration of a CPI in three of four patients treated with IFx-Hu2.0. This aligns with findings from the Phase 1 study and suggests a potential for tumor-specific T and B cell activation in patients resistant to anti-PD-1 CPIs. A Phase 3 accelerated approval trial for Merkel cell carcinoma is targeted to begin later this quarter.

The safety profile of IFx-Hu2.0 was confirmed, with only mild adverse events reported, primarily at injection sites. The merger between TuHURA and Kineta, which includes the acquisition of KVA12123, is anticipated to finalize in Q2 2025.

TuHURA Biosciences is focused on developing technologies to overcome resistance to cancer immunotherapy. The company’s pipeline includes IFx-2.0, an innate immune agonist, and Delta Opioid Receptor technology for bi-specific antibody drug conjugates and antibody peptide conjugates targeting suppressor cells in the tumor microenvironment.

This article is based on a press release statement. Investors should note that TuHURA’s next earnings report is scheduled for May 9, 2025. InvestingPro subscribers can access comprehensive financial analysis, including detailed Fair Value estimates and additional metrics that help evaluate biotech investment opportunities.

In other recent news, Kineta, Inc. has made several notable announcements. The company disclosed a change in its independent registered public accounting firm, with Marcum LLP resigning and CBIZ CPAs P.C. taking over. This transition follows CBIZ CPAs’ acquisition of Marcum’s attest business and aims to maintain continuity as the audit team remains largely the same. Notably, Marcum’s reports in the past two fiscal years raised concerns about Kineta’s financial stability, citing substantial doubt about its ability to continue as a going concern. Additionally, Kineta acknowledged material weaknesses in its internal control over financial reporting for the fiscal years ending in 2023 and 2024.

In another development, Kineta has entered into a securities exchange agreement with an existing investor, exchanging common stock and a pre-funded warrant for the cancellation of certain outstanding warrants. This transaction is part of a strategic move ahead of Kineta’s planned merger with TuHURA Biosciences, Inc., which requires stockholder approval. The merger is intended to expand Kineta’s capabilities in the pharmaceutical sector. The investor involved in the securities exchange has committed to voting in favor of the merger at the upcoming stockholders meeting. These recent developments provide insight into Kineta’s financial maneuvers and strategic plans.

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