A new clinical collaboration for B-cell malignancies

SAN DIEGO, CAMBRIDGE, Mass. and BEIJING—MEI Pharma and BeiGene, two pharmaceutical companies focusing on the treatment of cancer, have announced a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene’s zanubrutinib (BGB-3111), an investigational Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with B-cell malignancies.

ME-401 is an investigational oral phosphatidylinositol 3-kinase (PI3K) delta inhibitor. PI3K delta is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancer cells. ME-401 displays high selectivity for the PI3K delta isoform, and has distinct pharmaceutical properties from other PI3K delta inhibitors. It’s currently being clinically evaluated in patients with various B-cell malignancies. MEI is initiating a Phase 2 study to evaluate the efficacy, safety, and tolerability of ME-401as a single agent in patients with follicular lymphoma after failure of at least two prior systemic therapies, including chemotherapy and an anti-CD20 antibody. The Phase 2 study is intended to support an accelerated approval marketing application with the U.S. Food and Drug Administration.

“We are excited to be working with BeiGene to explore the potential of ME-401 in combination with zanubrutinib,” said Robert Mass, MD, chief medical officer of MEI Pharma. “Combinatorial approaches to fighting difficult to treat cancers historically have proven to be important in the delivery of better treatments to patients, and we believe that the data observed to date for ME-401, with its unique pharmaceutical properties, and for zanubrutinib support the evaluation of the combination for the treatment of patients with various B-cell malignancies.”

Under the terms of the clinical collaboration agreement, MEI will amend its ongoing Phase 1b trial to include evaluation of ME-401 in combination with zanubrutinib in patients with B-cell malignancies. Study costs will be shared equally by the parties, and MEI will supply ME-401 and BeiGene will supply zanubrutinib. MEI will retain full commercial rights for ME-401 and BeiGene will retain full commercial rights for zanubrutinib.

“Zanubrutinib is a potentially differentiated BTK inhibitor that is being globally developed in a number of B-cell malignancies both as a monotherapy and in combination. We look forward to exploring this interesting combination in patients with B-cell malignancies,” mentioned Jane Huang, MD, chief medical officer, hematology, at BeiGene.