Kineta Completes Enrollment for VISTA-101 Phase 1 Monotherapy in Advanced Solid Tumors

Kineta, Inc., a clinical-stage biotechnology company specializing in novel immunotherapies for cancer, has announced the completion of patient enrollment in the monotherapy segment of its VISTA-101 Phase 1 clinical trial. This trial is evaluating KVA12123, Kineta’s innovative VISTA-blocking immunotherapy, in patients with advanced solid tumors.

The monotherapy trial enrolled participants across six dose levels, from 3mg to 1000mg administered bi-weekly. Importantly, no dose-limiting toxicities or cytokine-related adverse events were observed. Currently, the company is continuing to enroll patients in cohorts that evaluate KVA12123 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).

Earlier this year, initial results from these studies were shared at the American Association of Cancer Research (AACR) Annual Meeting 2024. These results indicated promising outcomes, including partial response and stable disease in patients treated with the combination therapy, and durable stable disease in the monotherapy cohorts. Additionally, KVA12123 demonstrated a favorable safety and tolerability profile, with no dose-limiting toxicities or cytokine release syndrome (CRS)-associated cytokines at any dose level.

Craig W. Philips, President of Kineta, expressed satisfaction with the progress, stating, "We are pleased to successfully complete patient enrollment in the monotherapy arm, and we remain on target for completing full enrollment into this study before year end."

In another development on July 8, 2024, Kineta entered into an exclusivity and right of first offer agreement with TuHURA Biosciences, Inc., a Phase 3 immuno-oncology company. As part of this agreement, Kineta received a nonrefundable $5 million payment from TuHURA. This collaboration led to the reopening of patient enrollment in the VISTA-101 clinical trial in August 2024. The two companies are continuing their joint efforts on the ongoing Phase 1 clinical program for patients with advanced solid tumor cancer. On October 2, 2024, Kineta announced that TuHURA was exercising its right to extend their exclusivity and right of first offer per the agreement terms.

Kineta’s mission is to develop next-generation immunotherapies that can transform patients’ lives. Leveraging its expertise in innate immunity, the company is focused on creating differentiated immunotherapies that tackle significant challenges in current cancer treatments. Among its pipeline, Kineta has KVA12123, which is being tested in a Phase 1/2 clinical trial for advanced solid tumors, and a preclinical monoclonal antibody targeting CD27.

KVA12123 combines unique epitope binding with an optimized IgG1 Fc region, demonstrating strong tumor growth inhibition in preclinical models both as a monotherapy and in combination with other checkpoint inhibitors. This novel approach targets immune suppression within the tumor microenvironment and complements T cell-focused therapies. KVA12123 shows potential as an effective treatment for a variety of cancers, including non-small cell lung cancer (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer.

In February 2024, Kineta announced a major corporate restructuring aimed at significantly reducing expenses and conserving cash. This restructuring involved a substantial workforce reduction and the temporary halt of new patient enrollment in the VISTA-101 Phase 1/2 clinical trial. Concurrently, Kineta disclosed that it was exploring strategic alternatives to enhance stockholder value.