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MEI Pharma and Kyowa Kirin to Present Clinical Data from Ongoing Studies Evaluating Zandelisib for Lymphoma at the 16th International Conference on Malignant Lymphoma Virtual Scientific Program

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MEI Pharma (NASDAQ: MEIP) and Kyowa Kirin announced clinical data from a Phase 1b study evaluating zandelisib, a selective PI3K delta inhibitor for treating B-cell malignancies. The data will be showcased at the 16th International Conference on Malignant Lymphoma from June 18-22, 2021. The study aims to address patients with follicular lymphoma who progressed within 24 months of first-line therapy. Additionally, the Phase 3 COASTAL study will investigate zandelisib combined with rituximab versus conventional therapies for relapsed or refractory indolent non-Hodgkin's lymphoma.

Positive
  • Upcoming presentations highlight Phase 1b study results of zandelisib, potentially increasing investor interest.
  • Zandelisib is under development for B-cell malignancies, indicating a focus on addressing unmet medical needs in cancer treatment.
Negative
  • None.

SAN DIEGO and TOKYO, June 9, 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 utilizes the latest biotechnology to discover and deliver novel medicines, today announced clinical data from a Phase 1b study of zandelisib, an investigational selective phosphatidylinositol 3-kinase delta ("PI3K") inhibitor in clinical development for the treatment of B-cell malignancies, and the trial design of COASTAL, a Phase 3 study of zandelisib in combination with rituximab, will be highlighted in poster presentations at the 16th International Conference on Malignant Lymphoma (16-ICML) to be held June 18 – 22, 2021. 

Details on the two e-poster presentations are included below:

Title: Zandelisib, a PI3Kδ Inhibitor on Intermittent Schedule (IS) in Follicular Lymphoma Patients who Progressed within 24 Months of First-Line Chemoimmunotherapy (POD24)
Authors: John Pagel, et. al.
Abstract ID: 113

Title: COASTAL: A Phase 3 Study of the PI3Kδ Inhibitor Zandelisib with Rituximab (R) versus Immunochemotherapy in Patients with Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)
Authors: Wojciech Jurczak, et. al. 
Abstract ID: 
262

The abstracts are available on the Wiley Online Library website. The e-poster presentations will be available on the MEI Pharma website on June 18, 2021.

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 four clinical-stage assets, including zandelisib, currently in an ongoing Phase 2 clinical trial which may support accelerated approval applications with the U.S. Food and Drug Administration. 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 more than 70-year heritage, the comapny applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://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. 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.

 

Kyowa Kirin logo (PRNewsfoto/MEI Pharma, Inc.)

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/mei-pharma-and-kyowa-kirin-to-present-clinical-data-from-ongoing-studies-evaluating-zandelisib-for-lymphoma-at-the-16th-international-conference-on-malignant-lymphoma-virtual-scientific-program-301308689.html

SOURCE MEI Pharma, Inc.

FAQ

What is the significance of the Phase 1b study of zandelisib presented by MEI Pharma?

The Phase 1b study of zandelisib showed results that may indicate its effectiveness for patients with follicular lymphoma who experienced early progression after initial treatment.

When will the clinical data for zandelisib be presented?

The clinical data for zandelisib will be presented during the 16th International Conference on Malignant Lymphoma from June 18-22, 2021.

What are the goals of the Phase 3 COASTAL study involving zandelisib?

The Phase 3 COASTAL study aims to evaluate the efficacy of zandelisib in combination with rituximab compared to traditional immunochemotherapy in patients with relapsed or refractory indolent non-Hodgkin's lymphoma.

What does zandelisib target in cancer treatment?

Zandelisib is a selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor, targeting specific pathways involved in B-cell malignancies.

MEI Pharma, Inc.

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