KVA12123 Advances in VISTA-101 Trial with Positive Initial Results

Kineta, a clinical-stage biotechnology firm, has reported updates on its VISTA-101 Phase 1/2 clinical trial. The trial is assessing KVA12123, a drug being tested as a single treatment and in combination with Merck’s KEYTRUDA® (pembrolizumab), for advanced solid tumors. The drug has cleared the fifth of six single treatment dose levels and the second of four in combination with pembrolizumab. KVA12123 has shown good tolerance with no dose limiting toxicities or cytokine related adverse events.

In the single treatment phase, 12 out of 21 enrolled patients have received at least one baseline and follow-up scan. The best overall response in these patients is stable disease, averaging 15 weeks. Notably, a non-small cell lung cancer patient, who had failed six prior treatments, including checkpoint inhibitor therapy, has had stable disease for 28 weeks. As for the combination therapy phase, two out of three patients have shown stable disease and partial response, respectively, with significant reductions in target lesions.

The trial also observed dose-dependent induction of pro-inflammatory cytokines and chemokines, along with increases in non-classical monocytes, CD4+ and CD8+ T cells, and NK cells. Safety results are promising with no dose limiting toxicities observed.

Thierry Guillaudeux, Ph.D., Kineta’s Chief Scientific Officer, expressed satisfaction with the study’s progress and the safety profile of KVA12123. He highlighted the drug’s potential to offer a novel approach to managing solid tumor cancers by addressing immunosuppression in the tumor microenvironment.

However, due to restructuring and the pursuit of strategic alternatives to maximize shareholder value, Kineta has suspended new patient enrollment into the trial. Existing patients are allowed to continue participating. KVA12123 is a VISTA blocking immunotherapy, which is being evaluated for its potential to treat various types of cancer without inducing cytokine release syndrome.

Kineta is dedicated to developing innovative immunotherapies that can transform patient outcomes. The company’s pipeline includes KVA12123 and a preclinical monoclonal antibody targeting CD27. VISTA is a negative immune checkpoint that, when blocked, can induce a robust immune response to combat immunosuppression and promote anti-tumor activity.