MEI Pharma, Inc. (NASDAQ: MEIP), and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), 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,
SAN DIEGO and TOKYO, June 7, 2021 /PRNewswire/ -- 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 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, 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." About Zandelisib 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 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* 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. About MEI Pharma About Kyowa Kirin *American Cancer Society: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed March 1, 2021. Forward-Looking Statements Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; the impact of the COVID-19 pandemic on our industry and individual companies, including on our counterparties, the supply chain, the execution of our clinical development programs, our access to financing and the allocation of government resources; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
SOURCE MEI Pharma, Inc. |
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Company Codes: NASDAQ-SMALL:MEIP, Tokyo:4151, OTC-PINK:KYKOY |