Kineta Resumes VISTA-101 Trial Enrollment for KVA12123 in Advanced Solid Tumor Patients

Effective immediately, clinical sites in the VISTA-101 Phase 1/2 clinical trial can resume screening of patients for enrollment in the clinical study. To date, 30 patients have been enrolled in the clinical trial, which includes a monotherapy arm with KVA12123 and a combination arm utilizing KVA12123 together with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). Kineta anticipates the trial to be fully enrolled by the end of 2024.

On August 19, 2024, Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on developing novel immunotherapies targeting cancer immune resistance, announced the resumption of patient enrollment for its ongoing VISTA-101 Phase 1/2 clinical trial. This decision follows a temporary suspension of patient enrollment, initially announced on March 12, 2024, due to certain investors failing to meet their funding obligations in April 2024 as per a previously disclosed private placement financing agreement.

KVA12123 has successfully cleared the fifth of six monotherapy dose levels and two of the four cohorts in combination with pembrolizumab. Earlier this year, initial results showed partial response and stable disease in the combination cohorts, along with durable stable disease in the monotherapy cohorts, as presented at the American Association of Cancer Research (AACR) Annual Meeting 2024. Moreover, KVA12123 demonstrated a favorable safety and tolerability profile, with no dose-limiting toxicities and no signs of cytokine release syndrome-associated cytokines at any dose level.

Thierry Guillaudeux, Chief Scientific Officer of Kineta, expressed satisfaction with the resumption of the trial, stating, “We are very pleased to resume enrollment for VISTA-101. KVA12123 has been well tolerated with no dose-limiting toxicities and no cytokine release syndrome, and we continue to be encouraged by the initial data demonstrated. With enrollment now recommenced, we are focused on successful execution and working towards completing enrollment by the end of 2024.”

On July 8, Kineta entered into an exclusivity and right of first offer agreement with TuHURA Biosciences, Inc., a Phase 3 registration-stage immuno-oncology company. Under this agreement, Kineta received a $5 million nonrefundable payment from TuHURA. Both companies are collaborating on restarting patient enrollment for the trial.

James A. Bianco, Chief Executive Officer of TuHURA, commented on the importance of KVA12123, stating, “KVA12123 is a novel, differentiated new treatment alternative for patients with cancer. The completion of the enrollment in the Phase 1 portion of the trial this year is an important milestone for this exciting development program, and we are pleased to work closely with the Kineta team to resume enrollment.”

As part of the agreement, Kineta has granted TuHURA exclusive rights to acquire its worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other assets associated with the KVA12123 development program. This exclusive right remains valid until either the execution of a definitive agreement by TuHURA or one of its affiliates, or until 11:59 PM Eastern Time on October 1, 2024, subject to extension.

Kineta is a clinical-stage biotechnology company dedicated to developing next-generation immunotherapies that can significantly improve patients' lives. Utilizing its expertise in innate immunity, Kineta focuses on discovering and developing potentially differentiated immunotherapies that tackle major challenges in current cancer treatments. The company’s immuno-oncology pipeline includes KVA12123, a novel VISTA blocking immunotherapy in a Phase 1/2 clinical trial for advanced solid tumors, and a preclinical monoclonal antibody targeting CD27.

Combining unique epitope binding and an optimized IgG1 Fc region, KVA12123 has shown strong tumor growth inhibition in preclinical models, both as a monotherapy and in combination with other checkpoint inhibitors. KVA12123 offers a novel approach to mitigating immune suppression in the tumor microenvironment with a mechanism of action that complements T cell-focused therapies. This immunotherapy may prove effective for various cancers, including non-small cell lung cancer (NSCLC), colorectal cancer, renal cell carcinoma, head and neck cancer, and ovarian cancer.

In February 2024, Kineta announced a significant corporate restructuring to reduce expenses and preserve cash. This restructuring involved a substantial workforce reduction and the suspension of new patient enrollment in the ongoing VISTA-101 Phase 1/2 clinical trial. At that time, Kineta also revealed plans to explore strategic alternatives to maximize stockholder value.