Kineta has reported positive safety and biomarker data for its immuno-oncology candidate KVA12123 in a Phase I/II trial.

The VISTA-101 trial (NCT05708950), so called because the drug targets V-domain immunoglobulin suppressor of T cell activation (VISTA), has enrolled 11 patients with advanced solid tumours in the first three monotherapy dose-escalation cohorts.

Patients received either 3, 10 or 30 mg of KVA12123 by intravenous (IV) infusion every two weeks. Kineta announced the drug was well tolerated with no dose-limiting toxicities or cytokine-related adverse events.

The Seattle, US-based biotech also stated that the drug demonstrated better than expected dose-proportional pharmacokinetic profile. KVA12123 achieved more than 90% VISTA receptor occupancy in the 30 mg dose cohort.

Research has indicated that high VISTA expression in tumour correlates with poor survival in cancer patients. Blocking VISTA can drive anti-tumour responses.

Kineta states that, unlike other VISTA-targeting therapies, its candidate has demonstrated high monotherapy activity in preclinical models without introducing cytokine release syndrome – a systemic hyper-inflammatory response.

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By GlobalData

Kineta will continue with the monotherapy dose cohorts of KVA12123 in Part A of the study and initiate the second portion of the study to evaluate KVA12123 in combination with pembrolizumab.

Kineta plans to release the initial monotherapy efficacy data in Q4 2023.

Kineta CEO Shawn Iadonato said: “We are very pleased with the progress of our Phase I/II clinical trial, showing very compelling initial safety and pharmacokinetic data for KVA12123, which we believe significantly de-risks VISTA as a novel drug target.”

Kineta’s chief scientific officer Thierry Guillaudeux said: “We are thrilled to see greater than 90% VISTA receptor occupancy in patients treated with 30 mg dose. This indicates that we can saturate the target without dose-limiting toxicities and are close to achieving an optimal dose for KVA12123.”

This week, Sensei Therapeutics initiated the combination therapy arm in its Phase I/II trial investigating its VISTA-targeting monoclonal antibody.