TuHURA Biosciences and Kintara Therapeutics Announce Kineta Inc. Reopens Enrollment for VISTA-101 Trial of KVA12123 in Advanced Solid Tumor Cancer

On August 19, 2024, TuHURA Biosciences, Inc. ("TuHURA") and Kintara Therapeutics, Inc. ("Kintara") announced the reopening of patient enrollment in Kineta, Inc.'s ongoing VISTA-101 Phase 1/2 clinical trial. Kineta, which is focused on developing novel immunotherapies to combat cancer immune resistance, is trialing the VISTA blocking antibody, KVA12123. To date, 30 of the projected 39 patients have been enrolled, with the trial including both a monotherapy arm and a combination arm utilizing KVA12123 alongside Merck's anti-PD1 therapy, KEYTRUDA® (pembrolizumab). Full enrollment is anticipated by the end of 2024.

TuHURA, a phase 3 immune-oncology company, recently entered into an Exclusivity and Right of First Offer Agreement with Kineta, potentially acquiring the rights and assets related to KVA12123. Under this agreement, Kineta has already received a $5 million nonrefundable payment from TuHURA. Kineta and TuHURA are collaborating on reinitiating patient enrollment during TuHURA's due diligence period concerning the KVA12123 assets.

KVA12123 has successfully completed five out of six monotherapy dose levels and two out of four combination cohorts with KEYTRUDA®. Earlier in 2024, initial results reported at the American Association of Cancer Research (AACR) Annual Meeting showcased partial responses and stable disease in combination cohorts. Monotherapy cohorts also exhibited durable stable disease, with no dose-limiting toxicities or cytokine release syndrome (CRS)-associated cytokines at any dosage level.

Dr. James Bianco, CEO of TuHURA, expressed optimism about KVA12123's potential as a promising new cancer treatment. He highlighted the synergy between KVA12123 and TuHURA's IFx and Delta receptor technologies, viewing it as a potential Phase 2-ready checkpoint inhibitor. The expected completion of Phase 1 enrollment this year marks a significant milestone for the VISTA-101 program, and TuHURA is keen to advance the trial alongside Kineta.

Thierry Guillaudeux, Chief Scientific Officer of Kineta, emphasized the progress of the VISTA-101 trial, noting that KVA12123 has been well tolerated without any dose-limiting toxicities or CRS. Kineta aims to resume patient enrollment and complete it by the end of 2024.

KVA12123 is being developed as an infusion administered every two weeks. It is tested both as a standalone treatment and in combination with KEYTRUDA® for patients with advanced, treatment-resistant solid tumors. Competitive therapies targeting VISTA have shown limited monotherapy efficacy or induced CRS in clinical trials. However, KVA12123 has demonstrated significant monotherapy tumor growth inhibition in preclinical models without CRS in human trials. This novel immunotherapy approach aims to address immune suppression in the tumor microenvironment (TME) with a unique mechanism of action that complements T cell-focused therapies.

VISTA, a negative immune checkpoint, suppresses T cell function in various solid tumors. High VISTA expression is linked to poor survival in cancer patients and a lack of response to other immune checkpoint inhibitors. Blocking VISTA triggers a robust polyfunctional immune response, addressing immunosuppression and promoting anti-tumor activity.

TuHURA has also announced a definitive agreement with Kintara for an all-stock transaction to form a combined company, leveraging their expertise to advance a diversified late-stage oncology pipeline. The new entity will focus on TuHURA's personalized cancer vaccines and first-in-class bi-functional ADCs. Expected to operate under the name "TuHURA Biosciences, Inc." and trade on The Nasdaq Capital Market under the ticker "HURA," the transaction is slated to close in the third quarter of 2024, pending customary closing conditions and stockholder approval.

TuHURA is preparing to initiate a Phase 3 registration trial for its lead personalized cancer vaccine candidate, IFx-2.0, in combination with KEYTRUDA® for treating advanced Merkel Cell Carcinoma. Additionally, TuHURA is developing bi-functional ADCs targeting Myeloid Derived Suppressor Cells to prevent T cell exhaustion and acquired resistance to immunotherapies.

Kintara, based in San Diego, focuses on developing novel cancer therapies for patients with unmet needs. Its lead program, REM-001 Therapy, is aimed at treating cutaneous metastatic breast cancer (CMBC). REM-001 Therapy has demonstrated a high clinical efficacy and a robust safety profile in previous trials.

Both companies are committed to advancing innovative cancer treatments, leveraging their combined expertise to address critical unmet needs in oncology.

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