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Exscientia Receives Regulatory Nod to Start AI-Aided Phase I/II Trial

This article has been updated to correctly note that Exscientia received permission to start a Phase I/II trial of EXS-21546 from regulators in Belgium, not the UK.

NEW YORK – Exscientia on Monday said the Belgium Federal Agency for Medicinal and Health Products has approved its clinical trial application to conduct a Phase I/II trial of its A2A receptor antagonist with anti-PD-1 therapy in patients with relapsed or refractory renal cell carcinoma and non-small cell lung cancer.

In the IGNITE-AI trial, Exscientia will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of EXS-21546 in up to 110 patients who have previously received an immune checkpoint inhibitor. Exscientia used a simulation-guided clinical trial design to establish the parameters of the trial's two stages.

In the first stage, a dose-escalation study, investigators will use a continuous reassessment model to determine the maximum tolerated dose in 30 patients across seven dose levels. The MTD will then be used in an expansion cohort of 80 patients in the second stage of the trial. In this stage, the Oxford, UK-based firm will generate efficacy evidence for EXS-21546 in combination with a PD-1 inhibitor and gather data to increase statistical confidence in its multi-gene signature, dubbed the adenosine burden score (ABS). Exscientia plans to use this ABS to enrich the patient population for the drug in development.

EXS-21546 was developed with Exscientia's AI-based personalized medicine platform in partnership with Evotec. In June, Exscientia reported that in healthy volunteers the drug had the characteristics of its target profile, including potency, receptor selectivity, and low brain exposure with no central nervous system adverse events.

Exscientia hopes to explore the activity of EXS-21546 in other tumor types in future trials, including in breast cancer, with validated biomarkers for stratifying patients.