TuHURA Biosciences Secures Exclusive Rights to Kineta's Anti-VISTA Inhibitor KVA12123

TuHURA Biosciences, Inc., a company in late-stage clinical development specializing in immune-oncology, has entered into an Exclusivity and Right of First Offer Agreement with Kineta, Inc. This agreement concerns the potential acquisition of Kineta's KVA12123 anti-VISTA antibody and associated rights and assets. KVA12123 is a targeted anti-VISTA antibody checkpoint inhibitor designed to counteract VISTA immune suppression, remodel the tumor microenvironment, and tackle resistance to immunotherapies. The agent is currently undergoing a Phase 1/Phase 2 clinical study as both a monotherapy and in combination with Merck's KEYTRUDA® in patients with advanced solid tumors. So far, KVA12123 has shown favorable clinical safety and tolerability without dose-limiting toxicities or signs of Cytokine Release Syndrome at tested dosages.

In conjunction with the agreement, TuHURA has committed a $5 million payment to Kineta, half of which was paid upon signing, with the remaining amount due by mid-July 2024. Additionally, TuHURA sold $5 million worth of its common stock to an existing shareholder to sustain its financial health for ongoing and future clinical trials.

KVA12123 targets VISTA, a checkpoint molecule on quiescent T-cells preventing their activation. Unlike other inhibitors that act on activated T-cells, KVA12123's unique focus on VISTA makes it a promising candidate in cancer immunotherapy, especially for tumors resistant to current checkpoint inhibitors, such as certain gynecologic cancers. VISTA is also expressed on myeloid cells, including tumor-associated myeloid-derived suppressor cells, which contribute to immunosuppression within the tumor microenvironment.

Current preclinical and clinical data indicate that KVA12123 effectively inhibits tumor growth as a monotherapy without inducing Cytokine Release Syndrome, a common drawback of other VISTA-targeting therapies. This efficacy, combined with its unique mechanism of action, suggests that KVA12123 could be a significant addition to TuHURA's portfolio of immunotherapy solutions.

Dr. James Bianco, CEO of TuHURA, emphasized the potential synergies between KVA12123 and TuHURA’s existing technologies, suggesting that this acquisition could enhance their pipeline with a promising Phase 2-ready checkpoint inhibitor. The focus on VISTA opens new avenues for treating cancer types unresponsive to other checkpoint inhibitors.

Craig W. Philips, President of Kineta, expressed confidence in TuHURA’s capability to advance KVA12123, noting TuHURA's extensive expertise and experience in the field. The partnership is seen as a strategic move to introduce a new treatment option for cancer patients.

Additionally, TuHURA is in the process of merging with Kintara Therapeutics in an all-stock transaction aimed at combining their expertise and resources to advance a diversified oncology pipeline. This merger will focus on TuHURA's personalized cancer vaccines and bi-functional Antibody Drug Conjugates (ADCs), designed to overcome the challenges limiting the effectiveness of current cancer immunotherapies. Upon completion, the merged entity will operate under the name "TuHURA Biosciences, Inc." and will trade on The Nasdaq Capital Market under the ticker "HURA."

TuHURA's lead product, the personalized cancer vaccine IFx-2.0, is set to enter a Phase 3 registration trial as an adjunctive therapy to Keytruda® for treating advanced Merkel Cell Carcinoma. Their ADC technology aims to counter immune suppression in the tumor microenvironment by targeting Myeloid-Derived Suppressor Cells.

Overall, these developments mark significant progress in TuHURA's mission to develop next-generation cancer immunotherapies.