MEI Pharma is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. Our portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor that is being developed in combination with azacitidine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Our clinical development pipeline also includes ME-401, a highly selective, oral PI3K delta inhibitor, voruciclib, an oral, selective CDK inhibitor, and ME-344, a novel mitochondrial inhibitor.
In August 2016, we announced that the U.S. Food & Drug Administration granted Breakthrough Therapy Designation for Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are unfit for intensive chemotherapy. Later that month, we entered into an exclusive licensing, development and commercialization agreement with Helsinn Healthcare, SA, a Swiss pharmaceutical company, for Pracinostat in AML and other potential indications, including MDS.
ME-401 is a potent and selective oral inhibitor of PI3K delta, a molecular target that plays a critical role in the proliferation and survival of certain hematologic cancer cells. Results from a first-in-human, single ascending dose clinical study suggest that ME-401 has the potential for an improved therapeutic window compared to other PI3K delta inhibitors, with a half-life that supports once-daily dosing. A Phase Ib dose-escalation study of ME-401 in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or follicular lymphoma opened for enrollment in September 2016.
In September 2017, we entered into a license agreement for voruciclib, an oral and selective cyclin-dependent kinase (CDK) inhibitor, a class of drugs that has demonstrated significant clinical and commercial value, and is differentiated by its potent inhibition of CDK9. Voruciclib has been tested in more than 70 patients in multiple Phase 1 studies. In pre-clinical studies, voruciclib shows dose-dependent suppression of MCL1, an established resistance mechanism to the FDA-approved BCL2 inhibitor venetoclax (marketed as Venclexta™).
ME-344 is our isoflavone-derived mitochondrial inhibitor drug candidate. Results from a Phase I clinical study of ME-344 in patients with refractory solid tumors showed evidence of clinical activity, including a confirmed partial response in a heavily pre-treated patient with small cell lung cancer who remained on study for two years. An investigator-sponsored study of ME-344 in combination with the VEGF inhibitor bevacizumab (marketed as Avastin®) in HER2-negative breast cancer opened for enrollment in August 2016.
MEI Pharma is listed on the Nasdaq Capital Market (Nasdaq: MEIP).