MEI Pharma, Inc. Announces Expansion of Phase 1b Study Evaluating Zandelisib and Clinical Pipeline Update
January 04, 2021 at 07:00 am EST
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MEI Pharma, Inc. announced that the Phase 1b trial arm exploring zandelisib, an investigational selective phosphatidylinositol 3-kinase ("PI3K") delta inhibitor, in combination with zanubrutinib (marketed as BRUKINSA®), an inhibitor of Bruton's tyrosine kinase ("BTK") developed by BeiGene Ltd. ("BeiGene"), completed the safety evaluation stage in patients with B-cell malignancies and is expanding into disease specific B-cell malignancy cohorts. The Safety Review Committee recommended moving forward with a dosing regimen found to be generally well tolerated and active following a planned safety analysis. MEI Pharma also provided an update on pipeline programs and anticipated milestones for 2021 for zandelisib, voruciclib and ME-344. Zandelisib – PI3K delta inhibitor for the treatment of various B-cell malignancies: Completion of enrollment in the Phase 2 TIDAL study evaluating zandelisib as a monotherapy for patients with relapsed or refractory follicular lymphoma anticipated around the end of first quarter of 2021, subject to the continuing impact of the COVID-19 pandemic. Initiation of a second arm in the Phase 2 TIDAL study enrolling patients with relapsed or refractory marginal zone lymphoma anticipated in the first quarter of 2021. Initiation of the Phase 3 study of zandelisib in combination with rituximab evaluating follicular and marginal zone lymphoma patients who received one or more prior lines of treatment anticipated in mid-2021; this study is intended to act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma. Clinical updates for the Phase 1b study of zandelisib, including the combination with zanubrutinib, anticipated in mid-2021. Top line clinical data from the Phase 2 TIDAL study anticipated in the fourth quarter of 2021. Voruciclib – CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia: Program updates, including data from the Phase 1 program evaluating voruciclib in combination with venetoclax, anticipated in 2021. ME-344 – tumor selective mitochondrial inhibitor: Update plans for a potential Phase 2 pilot study of ME-344 in solid tumors anticipated by year-end 2021.
MEI Pharma, Inc. is a clinical-stage pharmaceutical company, which is engaged in developing novel and differentiated cancer therapies. Its drug candidate pipeline includes Voruciclib, an oral cyclin-dependent kinase 9 (CDK9) inhibitor, and ME-344, an intravenous small molecule mitochondrial inhibitor targeting the oxidative phosphorylation pathway. Voruciclib is a potent and selective orally administered CDK9 inhibitor. Voruciclib is being studied in a Phase 1 trial evaluating dose and schedule in patients with acute myeloid leukemia (AML) and B-cell malignancies as a single-agent, and in combination with the B-cell lymphoma 2 (BCL) inhibitor venetoclax (marketed as Venclexta) in patients with AML. ME-344 is a novel mitochondrial inhibitor drug candidate that demonstrates tumor selective activity in pre-clinical studies. It targets the OXPHOS pathway involved in the production of adenosine triphosphate (ATP).
MEI PHARMA, INC. 
