On October 17, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that the first patient has been dosed in Part B of its Phase 1/2 VISTA-101 clinical trial that will evaluate the safety and tolerability of the company’s VISTA blocking immunotherapy, KVA12123, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors (Press release, Kineta, OCT 17, 2023, View Source;utm_medium=rss&utm_campaign=kineta-announces-first-patient-dosed-in-phase-1-2-vista-101-clinical-trial-of-kva12123-in-combination-with-keytruda-pembrolizumab-in-patients-with-advanced-solid-tumors [SID1234636066]).

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"Dosing the first patient in the combination arm with KEYTRUDA and KVA12123 is a significant milestone for Kineta, and we are very pleased with the progress of our differentiated VISTA blocking immunotherapy," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We anticipate that the results from the combination arm will further build on the already encouraging initial safety, tolerability, and pharmacokinetic profile of KVA12123 observed in the monotherapy arm. We look forward to reporting initial clinical data for the combination treatment next year."

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 monotherapy and in combination with pembrolizumab which has now been initiated. Additionally, Parts A and B will be used to determine a recommended Phase 2 dose (RP2D) for Parts C and D. The clinical trial will transition into a Phase 2 study (Parts C and D) that will focus on dose expansion with an optimized dose.

KVA12123 is a VISTA blocking immunotherapy in development as a twice weekly infusion. The drug is being evaluated in a Phase 1/2 clinical trial for patients with advanced solid tumors. Competitive therapies targeting VISTA have demonstrated either poor monotherapy anti-tumor activity in preclinical models or induction of cytokine release syndrome (CRS) in human clinical trials. Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 demonstrates strong monotherapy tumor growth inhibition in preclinical models without evidence of CRS in clinical trial participants. KVA12123 effectively de-risks the VISTA target and provides a novel approach to address immune suppression in the tumor microenvironment (TME) with a mechanism of action that is differentiated and complementary to T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer.

Initial combination therapy clinical data as well as additional monotherapy safety and efficacy data are expected in Q2 2024.

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