MEI Pharma and Kyowa Kirin to Present Clinical Data from Phase 1b Study of Zandelisib in Combination with Zanubrutinib at the European Hematology Association 2021 Virtual Congress

Rhea-AI Summary

MEI Pharma and Kyowa Kirin have announced updated clinical data from a Phase 1b study of zandelisib, a selective PI3Kδ inhibitor, in combination with zanubrutinib, for patients with relapsed or refractory B-cell malignancies. This data will be presented at the European Hematology Association (EHA) 2021 Virtual Congress from June 9-17, 2021. The study aims to assess the drug combination's tolerability and efficacy, potentially leading to improved therapeutic options for patients. The abstract is accessible on the EHA website.

Positive

• Clinical data from Phase 1b study of zandelisib shows promise in treating B-cell malignancies.
• Presentation at EHA 2021 could raise visibility for zandelisib and attract investor interest.

Negative

• Regulatory uncertainties regarding FDA approval remain a risk for product candidates.

SAN DIEGO and TOKYO, May 12, 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 creating innovative medical solutions utilizing the latest biotechnology, today announced updated clinical data from a Phase 1b study of zandelisib, an investigational selective phosphatidylinositol 3-kinase delta ("PI3Kδ")  inhibitor in clinical development for the treatment of B-cell malignancies, in combination with zanubrutinib (marketed as BRUKINSA®), an inhibitor of Bruton's tyrosine kinase developed by BeiGene, Ltd., in patients with relapsed or refractory B-cell malignancies, will be highlighted in an oral presentation at the European Hematology Association (EHA) 2021 Virtual Congress to be held June 9 – 17, 2021.

Oral Presentation Title: Tolerability and Efficacy of the Combination of PI3K-Delta Inhibitor Zandelisib (ME-401) and BTK Inhibitor Zanubrutinib in Patients with Relapsed or Refractory (R/R) B-cell Malignancies: Initial Results
Session Title: Indolent & mantle cell lymphoma – Clinical
Presenter: Jacob Soumerai, M.D., lead author on the abstract, study investigator and Assistant Professor at Harvard Medical School and Massachusetts General Hospital Cancer Center
Abstract ID: S214

The abstract is available on the EHA Annual Congress website. All presentations will be made available on the EHA website for on-demand viewing on June 11, 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 heritage of 70+ years, we apply 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.

 

 

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SOURCE MEI Pharma, Inc.

FAQ

What is the purpose of the Phase 1b study of zandelisib?

The Phase 1b study aims to evaluate the safety and efficacy of zandelisib in combination with zanubrutinib for treating B-cell malignancies.

When will the clinical data be presented?

The clinical data will be presented during the EHA 2021 Virtual Congress from June 9-17, 2021.

What are the implications of the study results for MEI Pharma's stock?

Positive results could enhance MEI Pharma's value by potentially leading to accelerated FDA approval and increased investor interest.

What risks are associated with MEI Pharma's drug development?

Risks include regulatory hurdles, potential delays in FDA approval, and market acceptance challenges for their product candidates, including zandelisib.