MEI Pharma, Inc. announced that an abstract highlighting clinical data from the monotherapy dose escalation stage of the ongoing Phase 1 study evaluating voruciclib, a selective oral cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in combination with venetoclax (Venclexta®), a B-cell lymphoma 2 ("BCL2") inhibitor, in patients with acute myeloid leukemia (AML) or B-cell malignancies, will be presented during a poster session at the upcoming 65thAmerican Society of Hematology (ASH) Annual Meeting and Exposition to be held December 9 ? 12, 2023. The Phase 1 study is a two stage, open-label, 3+3 dose escalation and expansion study evaluating voruciclib, a CDK9 inhibitor, as a monotherapy and in combination with venetoclax (marketed as Venclexta®), a BCL2 inhibitor.

Inhibition of CDK9 blocks the production of Mcl-1, which is an established resistance mechanism to the BCL2 inhibitor venetoclax. The primary objectives of the study are to determine the safety and biologic effective dose of voruciclib monotherapy or voruciclib in combination with venetoclax. Secondary objectives of the study include assessing the preliminary efficacy, pharmacokinetics, pharmacodynamics, and biomarkers of voruciclib monotherapy or voruciclib in combination with venetoclax.

The first stage of the study, evaluating the dose and schedule of voruciclib as a single-agent in patients with relapsed and refractory (?R/R?) acute myeloid leukemia (?AML?) or B-cell malignances after failure of standard therapies, is now completed and the final results presented in the abstract. Stage 2 of the study is evaluating voruciclib in combination with standard dose venetoclax in patients with R/R AML.