On November 28, 2022 Evotec’s partner Exscientia plc (Nasdaq: EXAI) reported clinical trial application ("CTA") approval of a Phase I/II trial of EXS-21546, an A2a receptor antagonist, co-invented and developed through a collaboration between Exscientia and Evotec (Press release, Evotec, NOV 28, 2022, View Source [SID1234624487]). The approval enables site activation in the first European country.

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The Phase I/II trial will evaluate safety, efficacy, pharmacokinetics and pharmacodynamics of EXS-21546 in combination with anti-PD-1 therapy in up to 110 patients with immunotherapy relapsed or refractory renal cell carcinoma ("RCC") and non-small cell lung cancer ("NSCLC"). 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.

Exscientia intends to expand to additional tumour types, including breast cancer, in future trials after assessment of EXS-21546 activity and validation of its selection biomarkers.

Exscientia will lead further clinical development of the molecule and Evotec will retain co-ownership rights throughout clinical development.