MEI Pharma Announces Expansion of Phase 1b Study Evaluating Zandelisib and Clinical Pipeline Update
SAN DIEGO, Jan. 4, 2021 /PRNewswire/ --MEI Pharma, Inc.. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that the Phase 1b trial arm exploring zandelisib, an investigational selective phosphatidylinositol 3-kinase ("PI3K") delta inhibitor, in combination with zanubrutinib (marketed as BRUKINSA®), an inhibitor of Bruton's tyrosine kinase ("BTK") developed by BeiGene, Ltd. ("BeiGene"), completed the safety evaluation stage in patients with B-cell malignancies and is expanding into disease specific B-cell malignancy cohorts. The Safety Review Committee recommended moving forward with a dosing regimen found to be generally well tolerated and active following a planned safety analysis.
"Inhibition of the PI3K and BTK pathways with combination therapy is believed to present a promising opportunity for inducing a robust and durable response against various B-cell malignancies," said Richard Ghalie, M.D., senior vice president, clinical development, of MEI Pharma. "The intermittent dosing schedule and unique therapeutic profile of zandelisib makes it an attractive option for combination therapy. We are encouraged that the data to date supported the recommendation of the Safety Review Committee to move forward with the expansion cohorts, initially in follicular and mantle cell lymphomas, and we look forward to further exploring the potential of this and other combinations of zandelisib in patients with various B-cell malignancies with our global development partner, Kyowa Kirin."
A Series of Important Pipeline Updates in 2021
Zandelisib – PI3K delta inhibitor for the treatment of various B-cell malignancies
Voruciclib – CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
ME-344 – tumor selective mitochondrial inhibitor
MEI Pharma also confirmed today that it has a cash runway to fund operations through calendar year 2023.
H.C. Wainwright BIOCONNECT 2021 Virtual Conference Presentation
PI3K delta is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancers. Zandelisib displays high selectivity for the PI3K delta isoform and has distinct pharmaceutical properties from other PI3K delta inhibitors.
Ongoing clinical studies of zandelisib include TIDAL (Trials of PI3K DeltA in Non-Hodgkin's Lymphoma), a global Phase 2 clinical trial evaluating the candidate as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, MEI is planning a submission with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H.
Also ongoing is the multicenter, open-label, single-arm pivotal Phase 2 study of zandelisib in patients with indolent B-cell non-Hodgkin's lymphoma (iNHL) without Small lymphocytic lymphoma, lymphoplasmacytic lymphoma (LPL), and Waldenström's macroglobulinemia (WM) in Japan to evaluate zandelisib as a monotherapy for the treatment of Japanese patients with relapsed or refractory iNHL with at least two prior systemic therapies.
In October 2018, MEI entered a clinical collaboration with BeiGene to evaluate the safety and efficacy of zandelisib in combination with BeiGene's zanubrutinib for the treatment of patients with various relapsed or refractory B-cell malignancies. Clinical study costs in the Phase 1b study evaluating the combination are equally shared, and each company is supplying its own investigational agent. MEI retains all commercial rights to zandelisib and BeiGene retains all commercial rights to zanubrutinib.
In April 2020, MEI and Kyowa Kirin Co., Ltd. (Kyowa Kirin) entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin are co-developing and co-promoting zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.
In May 2020, updated data from the Phase 1b study of zandelisib was presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program. These data evaluating patients on an intermittent dosing schedule showed that treatment was generally well tolerated and demonstrated an 83% overall response rate in patients with relapsed or refractory follicular lymphoma. Responses appeared durable: median duration of response was not yet reached after median follow-up of 13.2 months (range: 3.0-27.6).
About MEI Pharma
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SOURCE MEI Pharma, Inc.
Company Codes: NASDAQ-SMALL:MEIP