MEI Pharma, Inc. (NASDAQ:MEIP) is trading higher in the mid-session on Monday.

Major Trigger:

MEI Pharma and Kyowa Kirin Announce First Patient with Marginal Zone Lymphoma Dosed in Expanded Global Phase 2 TIDAL Study Evaluating Zandelisib

Key Highlights:

• today announced the dosing of the first patient with relapsed or refractory marginal zone lymphoma enrolled in the recently added second arm of the global Phase 2 TIDAL study of zandelisib, a selective phosphatidylinositol 3-kinase (“PI3K”) delta inhibitor.
• Both arms of the TIDAL study are evaluating zandelisib as a monotherapy for the treatment of adults with follicular and marginal zone lymphomas. Subject to results from TIDAL, data from each study arm are intended to support separate accelerated approval applications with the U.S. Food and Drug Administration (FDA) under 21 CFR Part 314.500, Subpart H.
• The TIDAL study (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), to be conducted in the U.S., Europe, Asia and Oceania, is a global Phase 2 study evaluating zandelisib as a monotherapy across two study arms: the first study arm for the treatment of adults with relapsed and refractory follicular lymphoma and the second study arm for marginal zone lymphomas, in both cases after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody.
• The primary efficacy endpoint will be the rate of objective responses to therapy and other endpoints will include duration of response and tolerability of zandelisib.

Key Quote

“The initiation of the marginal zone lymphoma study arm in TIDAL is an important step in our commitment, in partnership with Kyowa Kirin, to identify and explore the full potential of zandelisib across multiple B-cell malignancies, including  combinations with other therapies, and to meet the need for new innovative medicines across a range of hematological cancers.,” said Richard Ghalie, M.D., chief medical officer, of MEI Pharma. 

Market Reaction: Stock Extends Rally

As of 1:03, MEIP stock moved up by 5.39% to $3.13 with more than 248K shares traded hands, compared to its average volume of 659K shares. The stock has moved within a range of $2.9500 – 3.1450 after opening the trade at $2.99.