MEI Pharma Announces FDA Clearance of IND Application for CDK Inhibitor Voruciclib

SAN DIEGO, CA, USA I January 8, 2018 I MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug Application (IND) for voruciclib, an orally available Cyclin Dependent Kinase 9 (CDK9) inhibitor, for patients with relapsed/refractory B-cell malignancies. Under this IND, MEI Pharma plans to initiate a Phase 1 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of voruciclib in patients with B-cell malignancies.

"Inhibiting the function of certain CDK family members has shown significant clinical activity in breast cancer. Voruciclib inhibits CDK9 which controls expression of MCL-1, a known mechanism of resistance to apoptosis. Therefore, voruciclib alone or in combination with a BCL-2 inhibitor such as venetoclax offers a potential novel approach for treatment of B-cell malignancies," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "With the FDA clearance of our IND, we look forward to advancing voruciclib through the clinic in the second quarter of 2018 to demonstrate its clinical and commercial value."

About Voruciclib

Voruciclib (formerly P1446A; ME-522) has been tested in more than 70 patients in multiple solid tumor Phase 1 studies and has been associated with side effects consistent with other drugs in its class, including nausea, vomiting and diarrhea. In pre-clinical studies, voruciclib alone induces cell death in multiple patient-derived chronic lymphocytic leukemia (CLL) samples1. In additional pre-clinical studies, voruciclib shows dose-dependent suppression of MCL-1 at concentrations achievable with doses that appeared to be generally well tolerated in the Phase 1 studies2. Studies have shown that MCL-1 is an established resistance mechanism to the B-cell lymphoma 2 (BCL-2) inhibitor venetoclax (marketed as Venclexta™)3.

About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The Company's portfolio of drug candidates includes pracinostat, an oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA. Pracinostat has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for use in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. Pracinostat is also being developed in combination with azacitidine in patients with high and very high-risk myelodysplastic syndrome (MDS). MEI Pharma's clinical development pipeline also includes ME-401, a highly differentiated oral PI3K delta inhibitor currently in a Phase Ib study in patients with relapsed/refractory CLL or follicular lymphoma, and voruciclib, an oral, selective CDK inhibitor shown to suppress MCL1, a known mechanism of resistance to BCL2 inhibitors. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-sponsored study in combination with bevacizumab for the treatment of HER2-negative breast cancer. Pracinostat, ME-401, voruciclib and ME-344 are investigational agents and are not approved for use in the U.S. For more information, please visit www.meipharma.com.

1 PLoS One. 2015 Nov 25;10(11):e0143685
2 Scientific Reports. 2017 Dec 21;7:(1):18007
3 Blood. 2016 Jun 23;127(25):3192-201

SOURCE: MEI Pharma

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