Exscientia plc announced the initiation of EXCYTE-2, an observational clinical study in acute myeloid leukaemia (AML) to investigate the relationship between ex vivo drug response (EVDR) measured in primary blood or bone marrow samples using the company?s deep learning, single-cell precision medicine platform and actual patient clinical response. The EXCYTE-2 study will collect blood and bone marrow samples from first-line patients with AML, with an option to expand to second-line patients. Both patient groups represent areas of high unmet medical need with low survival rates.

Biobanked tissue samples, alongside clinical patient data including diagnostic and outcome data, will be collected from treatment centres with samples to be processed by Exscientia or partner laboratories. These partner laboratories will be using Exscientia?s cloud-based AI to analyse samples remotely. In addition, the study allows for the evaluation of activity of EXS74539 (?539), Exscientia?s LSD1 inhibitor, in a large clinically annotated sample set.

This work has the potential to support the ongoing development of ?539, particularly in the selection of patients for future clinical trials. The EXCYTE-2 study builds on other previously initiated precision medicine focused studies, including EXALT-1 and EXCYTE-1. The EXALT-1 trial was an interventional trial and the first trial to leverage analysis of drug action in primary human cancer tissues using high content imaging and deep learning to guide treatment selection and improve outcomes in patients with late-stage haematological cancers. EXCYTE-2 will leverage the progress the company has made on its AI-driven precision medicine platform since the EXALT-1 trial was completed and will specifically evaluate earlier stage patient populations.

EXCYTE-1 is an ongoing prospective observational study focused on ovarian cancer. The EXCYTE-2 trial is a multicentre two-phase study evaluating the correlation between clinical and ex vivo drug response as measured using Exscientia?s AI-based precision medicine platform in AML. Initially the trial will focus on newly diagnosed AML patients, with the option to include relapsing/refractory AML patients after an interim analysis.

Blood or bone marrow collected from patients prior to initiation of therapy will be obtained from biobanks. The EVDR of commonly used standard of care therapies will then be evaluated in these patient samples by Exscientia?s AI-based precision medicine platform. These results will be compared against patients?

clinical response to treatment, which will be chosen and evaluated by physicians blinded to the EVDR data. Complete remission will be used as the primary clinical endpoint and assessed to monitor association with EVDR. Measurable residual disease is included as a secondary clinical endpoint.