Update on Phase 1/2 KVA12123 Trial for Advanced Solid Tumors

Kineta, a biotechnology firm, has reported positive results from its KVA12123 monotherapy and combination therapy trials in treating advanced solid tumors. KVA12123, a VISTA blocking immunotherapy, has shown to be well-tolerated without dose limiting toxicities and has induced pro-inflammatory biomarkers essential for anti-tumor activity. The Phase 1/2 clinical trial, VISTA-101, has dosed 18 patients so far, with 15 receiving monotherapy and 3 receiving a combination of KVA12123 and pembrolizumab. The drug has demonstrated a strong on-target effect by blocking VISTA, a negative immune checkpoint.

Kineta's CEO, Shawn Iadonato, expressed optimism regarding the biomarker data and the drug's safety profile, which allows for advancing to higher doses. The company aims to fully enroll the Phase 1 trial by April 2024. KVA12123 has shown a dose-proportional increase in drug exposure and has achieved over 90% VISTA receptor occupancy at certain doses. The drug has been developed to address immune suppression in the tumor microenvironment without causing cytokine release syndrome, which has been a challenge for other VISTA-targeting therapies.

Kineta is dedicated to developing next-generation immunotherapies that could potentially transform cancer treatment. Their pipeline includes KVA12123 and a preclinical monoclonal antibody targeting CD27. KVA12123 is positioned as an effective therapy for various cancers, including non-small cell lung cancer, colorectal, renal cell carcinoma, head and neck, and ovarian cancer. The drug's mechanism of action is differentiated and complementary to T cell-focused therapies, offering a novel approach to overcoming immune resistance in cancer.

The company's focus on innate immunity and the development of potentially differentiated immunotherapies is aimed at tackling the challenges associated with current cancer therapies. Kineta's mission is to leverage its expertise to discover and develop new treatments that can make a significant impact on patients' lives. Additional clinical efficacy data for KVA12123's monotherapy and combination therapy is expected to be released in the second quarter of 2024.