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MEI Pharma and Kyowa Kirin Announce Acceptance of Abstract for Presentation at the American Society of Clinical Oncology Annual Meeting 2022
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Rhea-AI Summary
MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. announced the presentation of Phase 2 TIDAL study data on zandelisib at the ASCO 2022 Annual Meeting, scheduled for June 3-7, 2022. The study evaluates the efficacy and safety of zandelisib, a PI3Kδ inhibitor for treating B-cell malignancies. The abstract ID is 7511, with a poster discussion led by Dr. Andrew David Zelenetz on June 4. MEI Pharma focuses on developing innovative cancer therapies, aiming for FDA approvals for its clinical-stage assets.
Positive
Presentation of Phase 2 TIDAL study data at ASCO 2022 may attract investor interest.
Zandelisib, a promising treatment for B-cell malignancies, highlights potential for future market approval.
Collaboration with Kyowa Kirin enhances credibility and support for drug development.
Negative
Forward-looking statements indicate uncertainties around FDA approvals and clinical trial outcomes.
Potential risks include delays in clinical trials and challenges in commercialization.
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 an abstract highlighting data and information from the Phase 2 TIDAL study evaluating the intermittent dosing of zandelisib, an investigational phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies, will be presented during a poster discussion session at the upcoming American Society of Clinical Oncology (ASCO) 2022 Annual Meeting to be held June 3 – 7, 2022.
Presentation Title: Efficacy and safety of zandelisib administered by intermittent dosing (ID) in patients with relapsed or refractory (R/R) follicular lymphoma (FL): Primary analysis of the global phase 2 study TIDAL
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter:Andrew David Zelenetz, Ph.D., M.D.
Date:Saturday, June 4th Abstract ID: 7511
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 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, including statements regarding the results of our clinical trials of zandelisib, the anticipated timing of our submission of an FDA marketing application for zandelisib, the anticipated timing of the disclosure of the final study data for our Phase 2 TIDAL trial, the timing and success of enrollment for our Phase 3 COASTAL trial, our projected financial position and our expected cash runway, the overall advancement of our product candidates in clinical trials and our plans to continue development of our product candidates. We may in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. 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 of our product candidates, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; the risk that our clinical trials are discontinued or delayed for any reason, including for safety, tolerability, enrollment, manufacturing or economic reasons; 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 Contacts:
Hiroki Nakamura (Global)
Corporate Communications Department media@kyowakirin.com
Lauren Walrath (North America)
VP, Public Affairs - Kyowa Kirin North America Tel: 646-526-4454
lauren.walrath.g4@kyowakirin.com
Source: MEI Pharma, Inc.
FAQ
What is the significance of the TIDAL study for MEI Pharma (MEIP)?
The TIDAL study evaluates zandelisib's effectiveness in treating B-cell malignancies, with its findings potentially impacting MEI Pharma's market position.
When will the TIDAL study results be presented?
The TIDAL study results will be presented during the ASCO Annual Meeting from June 3-7, 2022.
What are the risks associated with MEI Pharma's zandelisib treatment?
Risks include uncertainties in achieving FDA approval and possible delays in clinical trial processes.
How does Kyowa Kirin's involvement affect MEI Pharma's strategies?
Kyowa Kirin's collaboration may enhance MEI Pharma's credibility and resources in developing zandelisib.
