Kineta Announces First Patient Dosed in Phase 1/2 Clinical Study of KVA12123 for Advanced Solid Tumors:

SEATTLE, April 12, 2023 — Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today the first patient has been dosed in a Phase 1/2 clinical study evaluating KVA12123 alone and in combination with the immune checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. KVA12123 is a novel VISTA blocking immunotherapy designed to address immunosuppression in the tumor microenvironment (TME). Patients are currently being enrolled for this study across multiple clinical sites in the United States. Initial readout of Phase 1 data is expected by the end of 2023.

There is a strong clinical rationale for targeting VISTA with an antibody immunotherapy. VISTA is up-regulated after checkpoint inhibitor therapy and the protein is highly expressed in colorectal, renal cell carcinoma, head and neck, ovarian, and non-small cell lung cancers. These factors correlate with poor outcomes in cancer patients. 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 has demonstrated compelling activity in a range of preclinical cancer models as monotherapy and in combination with checkpoint inhibitor therapy. It was also observed to be well-tolerated in preclinical toxicology studies.

“New cancer immunotherapies continue to transform the standard of care and have significantly improved overall survival for patients with cancer. Despite the introduction of these novel therapies, most patients still progress following treatment leaving an urgent medical need for new treatments,” said Evan Yu, M.D., Section Head for Cancer Medicine, Clinical Research Division at the Fred Hutchinson Cancer Center and Principal Investigator of the study. “We are excited to kick off this Phase 1 trial to evaluate Kineta’s VISTA blocking immunotherapy as a potential approach to alleviate immunosuppression and promote antitumor immune responses in the tumor microenvironment.”

The Phase 1/2 clinical study (NCT05708950) is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and tumor response of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors. The study will be conducted in 4 parts. The Phase 1 study (Parts A and B) will focus on dose escalation of KVA12123 as a single-agent and in combination with pembrolizumab and will transition into a Phase 2 study (Parts C and D) that will focus on dose expansion. Additionally, Parts A and B will be used to determine a recommended Phase 2 dose (RP2D) for Parts C and D.

“KVA12123 represents a potentially promising new treatment option for a number of difficult-to-treat cancers,” said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. “Initiation of this first-in-human trial of KVA12123 marks an important milestone for Kineta and brings us one step closer to delivering a next-generation immunotherapy that addresses cancer immune resistance.”