MEI Pharma Updates on Voruciclib and Venetoclax Combo in Relapsed/Refractory AML Clinical Trial

MEI Pharma, Inc. has commenced enrollment for an additional 12 patients in an expansion cohort of a Phase 1 clinical trial. The study is assessing the combination of voruciclib, a CDK9 inhibitor, and venetoclax, a BCL2 inhibitor, for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The decision to expand the cohort was based on positive preliminary findings, which included anti-leukemic activity in heavily pretreated patients, a reduction in Mcl-1 levels, and a favorable safety profile without dose limiting toxicities.
Dr. Yesid Alvarado-Valero, a study chair at the University of Texas MD Anderson Cancer Center, highlighted the potential of voruciclib in suppressing MCL-1, a protein associated with resistance to venetoclax in AML and CLL patients. The combination therapy showed no added toxicity and early clinical activity, with disease responses observed in the treated patient group.
Richard Ghalie, M.D., MEI Pharma's chief medical officer, emphasized the need for new treatments for AML patients who relapse after venetoclax therapy, as resistance is common and salvage therapy benefits are limited. Voruciclib's data so far shows promise, with consistent Mcl-1 reduction indicating the drug's biological effect.
The Phase 1 study is open-label and involves multiple stages, including dose escalation and expansion. It has completed the evaluation of voruciclib as a monotherapy and is now focusing on the combination therapy with venetoclax. The study has enrolled 29 patients with a median age of 67 years, who had received a median of three prior treatments. The primary objectives are to establish the safety and effective biological dose of voruciclib, both as a single agent and in combination with venetoclax.
Initial safety and tolerability data for the combination therapy indicate that voruciclib at doses up to 300 mg for 14 consecutive days in a 28-day cycle with venetoclax was well tolerated, with no dose limiting toxicities. The most common grade 3 adverse events were related to myelosuppression from AML. In terms of efficacy, three out of 20 patients administered voruciclib at a dose of 100 mg or more achieved a response, with two showing complete response with incomplete hematologic recovery (CRi) and one achieving a morphologic leukemia-free state (MLFS). Additionally, 14 patients had stable disease lasting over 90 days.
Voruciclib is an investigational CDK9 inhibitor with potential applications in hematological malignancies and solid tumors. CDK9 is a gene transcription controller involved in cell cycle regulation and is a promising target for cancer treatment due to its role in controlling Mcl-1 and MYC, proteins often dysregulated in cancer cells. MEI Pharma is a clinical-stage pharmaceutical company dedicated to developing novel cancer therapies, with a focus on overcoming resistance mechanisms to standard treatments. The company's pipeline includes voruciclib and ME-344, a mitochondrial inhibitor targeting the oxidative phosphorylation pathway.

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