The primary objective is to evaluate VISTA as a biomarker to guide patient selection and treatment optimization for VISTA-targeted therapies where no standardized scoring method currently exists. Similar to standards established for PD-L1 immune checkpoint, there is a need to quantify VISTA expression in the tumor microenvironment (TME) to properly guide patient selection.

“We are excited to work with the Fred Hutchinson Cancer Center and tap into their cancer pathology expertise as we advance the clinical development of KVA12123,” said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. “VISTA expression has the potential to be a clinically relevant biomarker that we can use to inform our Phase 2 clinical study design with KVA12123 and ultimately predict positive anti-tumor responses to treatment.”

VISTA is a negative immune checkpoint that suppresses T cell function in a variety of solid tumors. High VISTA expression in tumor correlates with poor survival in cancer patients and has been associated with a lack of response to other immune checkpoint inhibitors. Blocking VISTA induces an efficient polyfunctional immune response to address immunosuppression and drives anti-tumor responses.

KVA12123 is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope at both physiologic and acidic pH levels. KVA12123 may be an effective immunotherapy for many types of cancer including NSCLC (lung), colorectal, renal cell carcinoma, head and neck, and ovarian. Initial clinical data from Kineta’s ongoing Phase 1/2 study of KVA12123 in advanced solid tumors is anticipated by end of 2023.