Kineta Announces FDA Acceptance of Investigational New Drug (IND) Application for KVA12123 for the Treatment of Advanced Solid Tumors

SEATTLE, WA, USA I November 15, 2022 I Kineta, Inc. (“Kineta” or the “Company”), a clinical-stage biotechnology company focused on developing next-generation immunotherapies that address cancer immune resistance, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug application (IND) to evaluate its VISTA blocking immunotherapy, KVA12123 (formerly referred to as KVA12.1), as a potential treatment for patients with advanced solid tumors.

Kineta is planning to conduct a Phase 1 ⁄ Phase 2 clinical study evaluating KVA12123 as a single agent and in combination with pembrolizumab 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 pembrolizumab. Kineta expects to initiate the clinical trial in the fourth quarter of 2022.

“The FDA acceptance of the IND enables Kineta to initiate the Phase 1/Phase 2 clinical trial in cancer patients with advanced solid tumor and demonstrates Kineta’s ability to execute on our clinical objectives. This marks the next stage of our journey toward developing KVA12123 as a potential important new anti-cancer immunotherapy,” said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. “We believe KVA12123 has the potential to improve clinical responses in cancer patients as a monotherapy as well as in combination with currently approved immunotherapies. We look forward to working with our clinical partners to start this study in the United States later this year and to announce interim results anticipated in late 2023.”

KVA12123 is expected to be a differentiated VISTA blocking immunotherapy to address the problem of immunosuppression in the tumor microenvironment (TME). It is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope. KVA12123 is being developed as an intravenous infusion.

Kineta is developing KVA12123 in large clinical and commercial indications where existing checkpoint inhibitors (CPIs) perform poorly, there is a high unmet medical need and VISTA expression in the tumor microenvironment is high. KVA12123 may be an effective immunotherapy for many types of cancer, including lung, colorectal, ovarian, renal cell, and head and neck as well as other “cold” difficult-to-treat solid tumors.

Kineta is a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives. Kineta has leveraged its expertise in innate immunity and is focused on discovering and developing potentially differentiated immunotherapies that address the major challenges with current cancer therapy. For more information on Kineta, please visit, and follow Kineta on Twitter, LinkedIn and Facebook.

PiiONEER™ Platform was designed for the discovery and development of potentially differentiated immunotherapies that address the major challenges with cancer immune resistance. Kineta believes that utilization of the PiiONEER™ Platform has potential to result in novel, well-characterized innate immuno-oncology lead antibody therapeutics that can be efficiently advanced into formal IND-enabling and clinical studies.

SOURCE: Kineta

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