Kyowa Kirin and MEI Pharma Announce First Patient Dosed in Japanese Pivotal Phase 2 Study of Zandelisib in Patients with Indolent B-cell non-Hodgkin's Lymphoma

TOKYO and SAN DIEGO, CA, October 2, 2020 – Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, and MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announced the first patient has been dosed in the pivotal Phase 2 study of zandelisib (formerly called ME-401), an oral, once-daily, investigational drug-candidate selective for phosphatidylinositol 3-kinase delta (PI3Kδ) in patients with indolent B-cell nonHodgkin's lymphoma (iNHL) without Small lymphocytic lymphoma, lymphoplasmacytic lymphoma (LPL), and Waldenström's macroglobulinemia (WM) in Japan. This Phase 2, multicenter, open-label, single-arm clinical study is conducted by Kyowa Kirin to evaluate zandelisib as monotherapy for treatment of Japanese patients with relapsed or refractory iNHL with at least two prior systemic therapies. Yoshifumi Torii, Ph.D., Vice President, Head of R&D Division of Kyowa Kirin, said “I am pleased that we have initiated the clinical study to seek regulatory approval in Japan. We are committed to delivering zandelisib as a new potential treatment option for Japanese patients and their physicians. And we continue to work closely with MEI Pharma to expand the global development program for zandelisib.” “The initiation of the Japanese Phase 2 pivotal study is an important addition to the zandelisib global development program,” stated Richard Ghalie, M.D., senior vice president, clinical development of MEI Pharma. “We are excited to continue working diligently in close partnership with Kyowa Kirin to build on the potential for zandelisib inside and outside the U.S., and to expand development into indications beyond follicular lymphoma.” 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-devlop 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. You can see this table by scrolling horizontally. 〈About the Clinical Study〉 Indication iNHL* *SLL, WM and LPL are excluded Phase Phase 2 Design Multicenter, open-label and single-arm study Administration group Zandelisib monotherapy Primary Endpoint Objective response rate (ORR) Sample size 60 Estimated study completion September 2024 Countries/Regions Japan About Zandelisib Zandelisib (formerly called ME-401) is an investigational cancer treatment being developed as an oral, once-daily, selective PI3Kδ inhibitor for the treatment of B-cell malignancies. In March 2020 the U.S. FDA granted zandelisib Fast Track designation. 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. Ongoing studies evaluating zandelisib include TIDAL (Trials of PI3K DeltA in Non-Hodgkin's Lymphoma) a Phase 2 clinical trial evaluating zandelisib as a monotherapy for the treatment of adults with follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an antiCD20 antibody. Subject to the results, upon completion TIDAL is intended to be submitted to FDA to support an accelerated approval marketing application under 21 CFR Part 314.500, Subpart H. Ongoing zandelisib studies also include a Japanese Phase 2 pivotal study in patients with iNHL without Small lymphocytic lymphoma, LPL and WM being conducted by Kyowa Kirin.

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