Exscientia Receives First CTA Approval to Initiate IGNITE-AI, a Phase 1/2 Trial of EXS-21546 in Patients with Advanced Solid Tumours - Seite 2

“We are proud to move forward with this industry-leading trial and the first patient study for Exscientia. Exscientia is a precision medicine company, and this trial exemplifies how we are extending our AI-driven, adaptive learning approach that we use in discovery now into development,” said Professor Andrew Hopkins, D.Phil., founder and Chief Executive Officer of Exscientia. "We believe that our precision medicine platform can help us select the right patients, which could allow us to translate the scientific potential for A_2A receptor antagonists into clinical results."

About the Phase 1/2 IGNITE-AI trial

The IGNITE-AI Phase 1/2 trial is a multicentre, open-label, two-stage clinical trial to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of EXS-21546 in combination with PD-1 inhibition. The Company intends to enrol patients with relapsed or refractory RCC or NSCLC who previously received treatment with an immune checkpoint inhibitor. By evaluating patients that have progressed after checkpoint inhibition therapy, the trial is designed to test whether A_2A receptor antagonism will restore the ability of the immune system to respond to checkpoint inhibitors.

The dose escalation portion of the trial will enrol a maximum of 30 patients across up to seven dose levels, depending on how many dose levels are needed to define the maximum tolerated dose (MTD). The dose expansion phase of the trial will commence upon identification of the MTD and will enrol up to 80 patients. The primary efficacy endpoint of the expansion phase is objective response rate (ORR).

EXS-21546 is a highly selective A_2A receptor antagonist ​​co-invented and developed through a collaboration between Exscientia and Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; Nasdaq: EVO). The molecule was identified in 9 months after testing 163 compounds and is one of the first AI designed drugs in the industry to enter the clinic. In June 2022, Exscientia reported topline data from a healthy volunteer study which confirmed Exscientia’s target product profile design, including potency, high receptor selectivity and expected low brain exposure with no CNS adverse events reported.