TuHURA Biosciences signs letter of intent to acquire Kineta's KVA12123

TuHURA Biosciences, Inc. (Nasdaq: HURA) said on November 25, 2024 that it has entered into a non-binding letter of intent with Kineta, Inc. (OTC Pink: KANT) regarding a potential transaction. Under the letter, TuHURA would acquire the rights to Kineta's VISTA inhibiting antibody, KVA12123, for a combination of cash and shares of TuHURA common stock, using a merger structure. The announcement came in a business update that also covered TuHURA's lead cancer program, two management hires and its funding.

What the letter does and does not settle

The letter is non-binding. TuHURA says the potential transaction is subject to negotiation, completion and execution of a definitive agreement. The release states no price, no cash amount, no share count and no closing conditions, and it names no bank, financial advisor or law firm for the deal.

TuHURA's milestone list targets a potential definitive agreement in Q4 2024, subject to continuing diligence and negotiations with Kineta, and completion of the acquisition in H1 2025. The two companies signed an Exclusivity and Right of First Offer Agreement on July 8, 2024. Before its merger with Kintara Therapeutics, Inc., TuHURA raised an additional $5 million to fund that agreement. The company says the money would be applied to the acquisition consideration if a definitive agreement is signed. If one is signed, TuHURA and Kineta say they intend to file a proxy statement/prospectus with the SEC, and Kineta's stockholders would vote on the transaction.

What TuHURA would be buying

KVA12123 has completed enrollment in its monotherapy arm, which the release says demonstrated safety at its highest dose level (1000mg). Kineta anticipates completing enrollment in the combination arm, where the antibody is given with Merck's anti-PD1 therapy Keytruda (pembrolizumab). Initial results were reported earlier in 2024 at the AACR Annual Meeting and recently at the SITC meeting. The release gives no efficacy figures from either arm, so TuHURA's description of KVA12123 as Phase 2 ready is the company's own. It plans to start Phase 2 trials of the antibody in H2 2025, but only if the Kineta merger transaction has been completed.

The lead program

TuHURA's lead candidate, IFx-2.0, is a first-in-class innate immune response agonist. TuHURA is preparing a single, randomized, placebo-controlled Phase 3 accelerated approval trial of IFx-2.0 added to Keytruda, versus pembrolizumab plus placebo, in first line treatment of checkpoint inhibitor-naive patients with advanced or metastatic Merkel cell carcinoma. The trial will run under a Special Protocol Assessment agreement with the FDA, reached through the FDA's Oncology Center of Excellence and its Project Front Runner initiative.

The primary endpoint is overall response rate. Progression-free survival is a key secondary endpoint that, if achieved, the company says can satisfy the requirement for a post-approval confirmatory trial. The data used to support the design came from a Phase 1b trial in patients who showed primary resistance to checkpoint inhibitors, a different group from the first line patients the Phase 3 will enroll. The release reports no results from that trial.

Legacy asset, hires and funding

From the Kintara merger, TuHURA holds REM-001, a late-stage photodynamic therapy being evaluated in an open-label 15-patient study for cutaneous metastatic breast cancer. As of October 7, 2024, four patients had been dosed, and the company expects to complete enrollment in Q4 2024. TuHURA plans to seek licensing opportunities for REM-001. Former Kintara stockholders hold contingent value rights to additional TuHURA shares if a minimum of 10 patients in the study are enrolled and complete 8 weeks of follow-up on or before December 31, 2025.

TuHURA named Peter O'Neill as Vice President, Clinical Operations, and Michael Krsulich as Head of Quality Assurance.

On money, the company says a $31 million fully funded financing closed in connection with the Kintara merger and is expected to fund planned operations late into the second half of 2025. The release gives no cash balance, net loss or cash used in operations. Its H1 2025 targets are the IFx-2.0 Phase 3 start, an inhibitor resistant basket trial and the Kineta closing. The release does not say how the cash portion of the Kineta price would be paid within the stated funding horizon.

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