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MEI Pharma and Kyowa Kirin Announce Acceptance of Three Abstracts for Presentation at the American Society of Hematology Annual Meeting 2022
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MEI Pharma and Kyowa Kirin have announced the presentation of three abstracts related to zandelisib, a PI3Kδ inhibitor for B-cell malignancies, at the American Society of Hematology Annual Meeting on December 10-13, 2022. The presentations will cover the efficacy and safety of zandelisib, both as a standalone treatment and in combination with zanubrutinib, along with immune-related toxicities. These findings may support ongoing clinical trials and potential marketing approvals globally.
Positive
Three abstracts related to zandelisib will be presented at ASH 2022, potentially highlighting its efficacy and safety.
The studies include final results from the TIDAL Phase 2 study on zandelisib for relapsed or refractory follicular lymphoma.
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SAN DIEGO & TOKYO--(BUSINESS WIRE)--
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 creating innovative medical solutions utilizing the latest biotechnology, today announced that three abstracts highlighting data and information from the clinical development program evaluating the intermittent dosing of zandelisib, an investigational phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor for the treatment of B-cell malignancies, will be presented at the upcoming American Society of Hematology (ASH) 2022 Annual Meeting to be held December 10 – 13, 2022.
Presentation Title: Efficacy and Safety of Single-agent Zandelisib Administered by Intermittent Dosing in Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Final Results of the TIDAL Phase 2 Study
Session Title: Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Presenter: Andrew David Zelenetz, Ph.D., M.D.
Date: Saturday, December 10, 2022 Publication Number: 1563
Presentation Title: Safety and Efficacy of the PI3Kδ Inhibitor Zandelisib in Combination with the BTK Inhibitor Zanubrutinib in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) or Mantle Cell Lymphoma (MCL)
Session Title: Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Presenter: Jacob D. Soumerai, M.D.
Date: Saturday, December 10, 2022 Publication Number: 78
Presentation Title: Mechanistic Insights into Immune Related Toxicities in Subjects with Relapsed/ Refractory Follicular Lymphoma Treated with Zandelisib
Session Title: Lymphomas: Translational–Non-Genetic: Poster I
Presenter: Binu Kandathilparambil Sasi, Ph.D.
Date:Saturday, December 10, 2022 Publication Number: 1553
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. MEI Pharma's portfolio of drug candidates contains multiple clinical-stage assets, including zandelisib, currently in ongoing clinical trials which may support marketing approvals with the U.S. Food and Drug Administration and other regulatory authorities globally. Each of MEI Pharma's pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. For more information, please visit www.meipharma.com. Follow us on Twitter @MEI_Pharma and on LinkedIn.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based global specialty pharmaceutical company with a heritage of more than 70 years, the company applies cutting-edge science, including expertise in antibody research and engineering, to address the needs of patients across multiple therapeutic areas such as nephrology, oncology, immunology/allergy and neurology. Across its four regions – Japan, Asia Pacific, North America and EMEA/International – Kyowa Kirin focuses on its purpose, to make people smile, and is united by its shared values of commitment to life, teamwork, innovation and integrity. Learn more about the Company at www.kyowakirin.com.
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 including, without limitation, statements regarding: the potential, safety, efficacy, and regulatory and clinical progress of zandelisib and our other product candidates, including the anticipated timing for initiation of clinical trials and release of clinical trial data and our expectations surrounding potential regulatory submissions, approvals and timing thereof, our business strategy and plans; and the sufficiency of our cash, cash equivalents and short-term investments to fund our operations. 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; the availability or appropriateness of utilizing the FDA’s accelerated approval pathway for our product candidates; final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; 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; adverse effects on the Company's business as a result of the restatement of our previously issued financial statements; 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.
