MEI Pharma Announces Expansion of Phase 1b Study Evaluating Zandelisib and Clinical Pipeline Update
- Safety Review Committee approved Phase 1b expansion cohorts in study arm evaluating zandelisib in combination with zanubrutinib in various B-cell maligniancies -
- MEI provides clinical pipeline outlook for 2021 -
- MEI Pharma to present at the H.C. Wainwright BIOCONNECT 2021 Virtual Conference -
Jan 4, 2021
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
MEI Pharma also provided an update on pipeline programs and anticipated milestones for 2021 for zandelisib, voruciclib and ME-344.
Zandelisib – PI3K delta inhibitor for the treatment of various B-cell malignancies
Completion of enrollment in the Phase 2 TIDAL study evaluating zandelisib as a monotherapy for patients with relapsed or refractory follicular lymphoma anticipated around the end of first quarter of 2021, subject to the continuing impact of the COVID-19 pandemic
Initiation of a second arm in the Phase 2 TIDAL study enrolling patients with relapsed or refractory marginal zone lymphoma anticipated in the first quarter of 2021
Initiation of the Phase 3 study of zandelisib in combination with rituximab evaluating follicular and marginal zone lymphoma patients who received one or more prior lines of treatment anticipated in mid-2021; this study is intended to act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma
Clinical updates for the Phase 1b study of zandelisib, including the combination with zanubrutinib, anticipated in mid-2021
Top line clinical data from the Phase 2 TIDAL study anticipated in the fourth quarter of 2021
Voruciclib – CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
Program updates, including data from the Phase 1 program evaluating voruciclib in combination with venetoclax, anticipated in 2021
ME-344 – tumor selective mitochondrial inhibitor
Update plans for a potential Phase 2 pilot study of ME-344 in solid tumors anticipated by year-end 2021
MEI Pharma also confirmed today that it has a cash runway to fund operations through calendar year 2023.
KZA Price at posting:
$1.30 Sentiment: Buy Disclosure: Held
, 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.
