FDA Accepts Investigational New Drug Application for KVA12123 to Treat Advanced Solid Tumors

The FDA’s decision to grant KVA12123 an investigational new drug application now allows its manufacturer, Kineta, to begin a clinical trial assessing its safety and efficacy across several solid tumors.

The FDA has accepted an investigational new drug application (IND) for KVA12123 for the treatment of patients with advanced solid malignancies, according to a press release from developer Kineta.1

There are plans for a phase 1/2 clinical trial to assess KVA12123 alone or in combination with pembrolizumab (Keytruda) in a patient population with advanced solid cancers. The trial will assess the safety, tolerability, pharmacokinetics, pharmacokinetics, and treatment response for both the monotherapy and combination regimen. The trial is expected to start enrolling patients by the end of the year.

“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,” Shawn Iadonato, PhD, CEO at Kineta, said in a press release. “We believe KVA12123 has the potential to improve clinical responses in [patients with] cancer as a monotherapy as well as in combination with currently approved immunotherapies.”

Iadonato noted that the company expects to release interim results from the trial in late 2023.

KVA12123 is a differentiated VISTA blocking immunotherapeutic that might work to resolve immunosuppression within the tumor microenvironment. Moreover, it is a human engineered IgG1 monoclonal antibody that binds to VISTA via a unique epitope that is administered through intravenous infusion.

The agent was designed to fulfill a role in which current checkpoint inhibitors don't perform well, thus potentially fulfilling an unmet need. According to the release, the agent may be an effective treatment for those with head and neck, colorectal, ovarian, renal cell, and lung cancers, as well as additionally difficult to treat solid tumors.

Findings from a non-human primate toxicology phase 1/2 study of KVA12123 in solid tumors showed that there were no reported deaths, overt clinical signs or weight loss.2 Moreover, there were no treatment-related data for clinical pathology end point or changes in cytokine release syndrome levels.

Based on this, the agent was pushed forward to be assessed as part of the aforementioned study. In part A, KVA12123 will be evaluated at several escalating dose levels, including 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, and 1000 mg every 2 weeks. In part B, the agent will be assessed in combination with pembrolizumab every 3 weeks at several dose levels, including 30 mg, 100 mg, 300 mg, and 1000 mg.


  1. Kineta announces FDA acceptance of investigational new drug (IND) application for KVA12123 for the treatment of advanced solid tumors. News release. Kineta. November 15, 2022. Accessed November 15, 2022. http://bit.ly/3EybsNL
  2. Lustig K, Frazier E, Kabi N, et al. KVA12123: an anti-VISTA monoclonal antibody with strong single agent anti-tumor activity and no evidence of cytokine mediated toxicity. 2021 Society for Immunotherapy of Cancer; November 8-November 12; Boston, MA; abstract 425.