MEI Pharma and BeiGene have entered into a clinical collaboration to evaluate the safety and efficacy of the combination of their respective drugs ME-401, an investigational PI3K delta inhibitor, and zanubrutinib, an investigational BTK inhibitor, for the treatment of patients with B-cell malignancies.
MEI Pharma chief medical officer Robert Mass said: “We are excited to be working with BeiGene to explore the potential of ME-401 in combination with zanubrutinib.
“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.”
BeiGene hematology chief medical officer Jane Huang said: “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.”
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.
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 is 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.
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B cell malignancies.
Source: Company Press Release