MEI Pharma Initiates Strategic Realignment

MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that it plans to initiate a realignment of its clinical development efforts following the discontinuation of global development outside Japan of its PI3K delta inhibitor, zandelisib. As part of the realignment, the company plans to streamline its organization towards the development of two earlier clinical-stage assets, voruciclib and ME-344. Following completion of the workforce reductions, MEI expects its existing cash, cash equivalents and marketable securities will be sufficient to fund operations through clinical data milestones for both voruciclib and ME-344. The company further announced that it has engaged Torreya Partners as financial advisor to help explore additional strategic opportunities.

“In light of the determination we made with our global partner, Kyowa Kirin, to discontinue development of zandelisib outside of Japan after a recent meeting with FDA, we have had to make some tough decisions. We intend to continue development of our earlier-stage clinical assets, streamline MEI’s operations towards these efforts, and consider additional strategic opportunities,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. “As we move forward with the planned development of voruciclib and ME-344, two investigational candidates representing potential treatments for various hematological and solid tumor cancers, I want to express my deep gratitude to the MEI team. I am very proud of our work, and the simply exemplary efforts, to develop zandelisib. I also want to recognize the collaborative efforts of our partner, Kyowa Kirin, and sincerely thank all the healthcare providers and patients that contributed to zandelisib’s development.”

Expected Drug Candidate Pipeline Developments

Voruciclib – Oral cyclin-dependent kinase 9 (CDK9) inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia, as well as solid tumors.

• After initiating dosing of the first patient in November, continue advancing the dosing of patient cohorts evaluating voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia in the ongoing Phase 1 study.
  • Provide a clinical data update in CY2023.
• Continue preclinical evaluation of the role CDK9 in cMYC regulation in solid tumors expressing KRAS mutations to support potential clinical development as a treatment for solid tumors.

ME-344 – Tumor selective mitochondrial inhibitor for the treatment of solid tumors.