NEW YORK – Exscientia on Wednesday said it has begun studying its functional medicine platform in patients with acute myeloid leukemia.
In the EXCYTE-2 trial, investigators will analyze blood and bone marrow samples from patients with AML and compare the ex vivo drug response (EVDR) generated by Exscientia's artificial intelligence platform with the patient's clinical response to therapy. Initially, they will include only newly diagnosed AML patients in the study, but the study design includes an option to enroll patients with relapsed or refractory AML following an interim analysis.
Patients in the study will receive treatment chosen by their physicians, who will be blinded to the EVDR data. Doctors can give Exscientia's LSD1 inhibitor EXS74539, among other treatments, to study participants. The researchers will track complete remission as the primary endpoint and measurable residual disease as a secondary endpoint.
Treatment centers will collect blood and tissue samples from patients as well as clinical data such as diagnostic results and outcomes information. This data will then be processed by Exscientia or partner laboratories using Exscientia's cloud-based AI platform. In a statement, Exscientia said that this study will allow it to evaluate EXS74539 "in a large clinically annotated sample set" and "has the potential to support the ongoing development of '539, particularly in the selection of patients for future clinical trials."
The Oxford, UK-headquartered company has tested the ability of the AI platform to select treatments for patients with hematologic malignancies. That prospective study, dubbed EXALT-1, showed that 54 percent of patients whose treatment was guided by an image-based single-cell functional medicine approach had a 1.3-fold enhancement in progression-free survival compared with their previous therapy, including some patients who had responses lasting three times longer.
The EXCYTE-2 study "continues our focus on establishing AI-led ex vivo drug testing in human tissue samples as the most comprehensive strategy for preclinical testing of novel therapies, additive to mouse and other animal models," Nikolaus Krall, executive VP of precision medicine at Exscientia, said in a statement. "A robust correlation between our platform's results and clinical outcomes has the potential to change clinical practice for the benefit of AML patients."