MEI Pharma (MEIP)
MEI Pharma is a late clinical stage oncology-focused biotech company with four pipeline products in development. Pracinostat is clinically the most advanced development. Pracinostat plus azacitidine is currently undergoing a Phase III trial as a potential 1st-line therapy in acute myeloid leukemia (AML) unfit for induction therapy. Pracinostat is an orally available histone deacetylase (HDAC) inhibitor and pracinostat/azacitidine combination has received a Breakthrough Therapy designation by the FDA. MEIP has partnered pracinostat with Helsinn Group for the clinical and commercial development. Pracinostat is also in a Phase II study in high and very high risk myelodysplastic syndrome (MDS). ME-401 is a differentiated PI3K delta inhibitor that MEIP is scheduled to commence a pivotal trial in follicular lymphoma (FL) as a potential 3rd-line treatment before year-end 2018. ME-401 is currently undergoing a Phase I study in chronic lymphocytic leukemia (CLL) and FL with data readout expected in 2Q18 at the ASCO meeting. MEIP’s third pipeline product is voruciclib, a novel selective CDK9 inhibitor that has the potential to mitigate the drug resistance of Bcl-2-based drug, like Venclexta. MEIP plans to start a Phase Ib dose-finding study in 2Q18 evaluating voruciclib and voruciclib plus venetoclax in relapsed and refractory B cell malignancies. ME-344, a novel mitochondrial inhibitor, in combination with Avastin is undergoing an investigator-sponsored Phase II study in HER2-negative breast cancer with interim data readout expected in 2Q18. The MOA of ME-344 is to overcome the metabolic plasticity developed by cancer cell after the antiangiogenic therapy and potentiate the treatment efficacy of an antiangiogenic therapy.
MEIP-2018-11-05-Kyowa Hakko Kirin deal
MEIP-2018-06-28-Major Focus is on ME-401 in FL
MEIP-2018-05-17-First glance on ASCO abstract