On June 7, 2021 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, reported 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 (Press release, MEI Pharma, JUN 7, 2021, View Source [SID1234583656]). 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.

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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.

"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 Seràgnoli 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 (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) 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."

About Zandelisib
Zandelisib (formerly called ME-401), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. In March 2020 the U.S. FDA granted zandelisib Fast Track designation for treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies..

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin will co-develop and co-promote 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. and will pay MEI escalating tiered royalties on ex-U.S. sales.

Other than the TIDAL study, ongoing zandelisib studies also include a Phase 2 pivotal study in Japan in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) conducted by Kyowa Kirin.

About the TIDAL Phase 2 Study
The TIDAL study (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma) 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 endpoints of the study are the objective response rate and the tolerability of zandelisib.

Subject to the results, data from each study arm are intended to support separate accelerated approval marketing applications with FDA under 21 CFR Part 314.500, Subpart H.

The study is evaluating zandelisib administered once daily at 60 mg for two 28-day cycles and then on an intermittent schedule (IS) of once daily dosing for the first seven days of each subsequent 28-day cycle. Approximately 120 follicular lymphoma and 64 marginal zone lymphoma patients will be enrolled and treated with the IS regimen. 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.

The TIDAL study is being conducted in the US, Europe, Asia and Oceania. More information about this trial is available at ClinicalTrials.gov.

About Marginal Zone and Follicular Lymphomas*
Marginal zone lymphoma (MZL) is a group of indolent, or slow growing, lymphomas. The disease forms on B-cells, a type of white blood cell called a lymphocyte. MZL accounts for approximately 5% to 10% percent of all non-Hodgkin lymphoma cases; over 77,000 cases of non-Hodgkin lymphoma are diagnosed in the U.S. each year. The average age at diagnosis for most marginal zone lymphomas is 60 years.

Follicular lymphoma (FL) is the most common indolent lymphoma, comprising about 20-30% of all non-Hodgkin lymphomas. The disease also forms on B cells, is chronic in most cases and tends to progress slowly. Most people diagnosed with FL are over 65 years of age. Sometimes follicular lymphomas can change into diffuse large B-cell lymphoma, a fast-growing (aggressive) type of NHL.