MEI Pharma Announces Update of Ongoing Phase 1 Study Evaluating Oral CDK9 Inhibitor Voruciclib in Patients with Acute Myeloid Leukemia or B-Cell Malignancies

MEI Pharma, a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, has announced an update to the Phase 1 study evaluating voruciclib, an orally administered cyclin-dependent kinase 9 (“CDK9”) inhibitor, in patients with relapsed and refractory (“R/R”) acute myeloid leukemia (“AML”) or B-cell malignancies.

These results demonstrate that, as of the data cut off, voruciclib alone or in combination with venetoclax (Venclexta®), a BCL2 inhibitor, was generally well tolerated with no significant myelosuppression. The results further demonstrated encouraging clinical activity in heavily pretreated patients administered voruciclib alone and at the initial dose level in combination with venetoclax. These early results are consistent with the hypothesized ability of voruciclib to inhibit MCL-1 via CDK 9 inhibition to address a common venetoclax resistance mechanism. Dose escalation is continuing in the voruciclib and venetoclax combination arm in patients with R/R AML.

“These initial results provide encouraging support for the potential of voruciclib administered in combination with venetoclax to address a common resistance mechanism to venetoclax therapy and deliver improved clinical benefit to patients without significant myelosuppression,” said Dan Gold, Ph.D., president and chief executive officer of MEI Pharma. “We look forward to disclosing more data from this study around year-end, including data from patients receiving higher doses of voruciclib plus venetoclax, to further evaluate the potential of the combination to safely provide synergistic benefit to patients.”