On October 17, 2022 Kineta, Inc. ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada) (Press release, Kineta, OCT 17, 2022, View Source;utm_medium=rss&utm_campaign=kineta-announces-clinical-collaboration-with-merck-to-evaluate-kva12123-in-combination-with-keytruda-pembrolizumab-in-cancer-patients-with-advanced-solid-tumors [SID1234622054]). Under this collaboration, Kineta will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KVA12123 (formerly KVA12.1), its novel anti-VISTA monoclonal antibody, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced solid tumors.

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VISTA is a key driver of immunosuppression in the tumor microenvironment. VISTA is up-regulated after checkpoint inhibitor therapy that has been associated with treatment failure and 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 and at physiologic and acidic pH levels. In preclinical studies, KVA12123 demonstrated promising anti-tumor activity both as a single agent and in combination with PD-1 checkpoint inhibitor therapy.

"Treatment with PD-1 inhibitors as a monotherapy or in combination with other treatments has become a recommended first-line treatment and has dramatically improved outcomes for many cancer patients. However, for patients who failed to achieve a response or who relapse, treatment options are limited. We believe that KVA12123 is a potential best-in-class VISTA blocking immunotherapy that may drive strong anti-tumor efficacy and deliver a highly differentiated product profile across a range of solid tumors," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We are excited to enter into this collaboration with Merck to evaluate KVA12123 in combination with KEYTRUDA in cancer patients later this year."

Kineta is planning to conduct a Phase 1/2 clinical study evaluating KVA12123 as a single agent and in combination with KEYTRUDA in patients with advanced solid tumors. The objectives of the study are to evaluate the safety, tolerability, pharmacokinetics and anti-tumor responses of KVA12123 alone and in combination with KEYTRUDA with interim results anticipated in late 2023. Kineta is responsible for conducting this study, which it expects to initiate in the fourth quarter of 2022.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.