Benzinga | Jun 7, 2021 08:03AM EDT

MEI Pharma, Kyowa Kirin Report First Patient Dosed In Phase 2 Study For Marginal Zone Lymphoma Candidate

MEI Pharma, Inc. (NASDAQ:MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, 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 evaluatingzandelisib 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.

"Relapsed and refractory marginal zone lymphoma is an incurable disease for which there are limited available therapeutic options for patients who may not have responded to conventional therapies," said Pier Luigi Zinzani, M.D., Ph.D. Professor, Institute of Hematology Ser?gnoli University of Bologna, Bologna, Italy, and co-chair of the global TIDAL study. "Given the positive and encouraging results to date with zandelisib, we are eager to further evaluate the potential benefit zandelisib may offer patients with marginal zone lymphoma."

"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. "We continue to anticipate multiple important milestones from the zandelisib program this year, including topline data from our Phase 2 TIDAL study in fourth quarter and clinical data updates from the ongoing Phase 1b study at ASCO, EHA and ICML. We also will continue expansion of the zandelisib clinical program evaluating additional indications and combinations, including the start around mid-year of COASTAL, a Phase 3 study evaluating zandelisib in combination with rituximab in patients with second line follicular and marginal zone lymphoma."

"I am delighted that this important milestone was achieved for zandelisib in the marginal zone lymphoma study arm of the global TIDAL study," said Yoshifumi Torii Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. "Under the partnership with MEI, we continue to work with medical professionals and patients to demonstrate zandelisib's potential to help those in need with B-cell malignancies."