Kineta, Inc. has announced the completion of enrollment in the monotherapy arm of its Phase 1 VISTA-101 clinical trial. This trial is evaluating KVA12123, Kineta’s novel VISTA blocking immunotherapy, in patients with advanced solid tumors. The company is now focusing on enrolling patients in cohorts that will evaluate KVA12123 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).
The monotherapy portion of the trial included patients in 6-dose cohorts ranging from 3mg to 1000mg administered every two weeks. Notably, the study has reported no dose-limiting toxicities or cytokine-related adverse events.
Initial Results and Safety Profile
Earlier this year, at the American Association for Cancer Research (AACR) Annual Meeting 2024, Kineta presented initial results from the trial. These results demonstrated partial responses and stable disease in the cohorts evaluating KVA12123 in combination with pembrolizumab. Furthermore, durable stable disease was observed in the monotherapy cohorts. The initial data also indicated a favorable clinical safety and tolerability profile for KVA12123, with no dose-limiting toxicities and no evidence of CRS-associated cytokines at any dose level.
Strategic Collaboration with TuHURA Biosciences
Kineta has also been in collaboration with TuHURA Biosciences, Inc., an immuno-oncology company in Phase 3 registration, to overcome resistance to cancer immunotherapy. In July 2024, Kineta entered into an exclusivity and right of first offer agreement with TuHURA, receiving a $5 million nonrefundable payment. Enrollment in the VISTA-101 clinical trial was reopened in August 2024 as a result of this collaboration. TuHURA exercised its right to extend their exclusivity and right of first offer on October 2, 2024.
About KVA12123
KVA12123 is designed to address immune suppression in the tumor microenvironment. Preclinical models have demonstrated strong tumor growth inhibition both as a monotherapy and in combination with other checkpoint inhibitors. Kineta believes KVA12123 may be an effective immunotherapy for various types of cancer, including non-small cell lung cancer (NSCLC), colorectal cancer, renal cell carcinoma, head and neck cancer, and ovarian cancer.
Company Statement
"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," said Craig W. Philips, President of Kineta.
