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MEI Pharma Announces Acceptance of Three Abstracts for Presentation at the 63rd Annual American Society of Hematology Annual Meeting

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MEI Pharma, Inc. (NASDAQ: MEIP) announced the presentation of three abstracts at the 63rd Annual American Society of Hematology Meeting from December 11 to 14, 2021. The studies include: 1) a Phase 3 trial of zandelisib with rituximab versus standard immunochemotherapy for indolent non-Hodgkin’s lymphoma; 2) ME-344's enhancement of venetoclax activity against acute myeloid leukemia (AML); and 3) a Phase 1 study of voruciclib in B-cell malignancies. The latter showed promising results with no significant toxicities and disease stabilization in heavily treated patients.

Positive
  • Three abstracts presented at ASH highlight advancements in MEI Pharma's oncology drug pipeline.
  • Zandelisib study shows potential as a treatment for relapsed indolent non-Hodgkin’s lymphoma.
  • ME-344 demonstrates enhanced activity against AML when combined with venetoclax.
  • Voruciclib study exhibits good tolerance and disease stabilization in difficult-to-treat patients.
Negative
  • None.

SAN DIEGO--(BUSINESS WIRE)-- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that three abstracts highlighting data and information from three oncology drug candidates in its pipeline will be presented at the upcoming 63rd Annual American Society of Hematology (ASH) Annual Meeting to be held December 11 – 14, 2021.

Details on the poster presentations are included below:

Title: Coastal: A Phase 3 Study of the PI3Kδ Inhibitor Zandelisib with Rituximab (R) Versus Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma (iNHL)
Authors: Wojciech Jurczak, M.D., Ph.D., et. al.
Date: Sunday, December 12, 2021, 6:00 PM - 8:00 PM ET
Abstract ID: 2430

Summary of study methods: the COASTAL study is a randomized, open-label, controlled multicenter phase 3 trial to investigate the safety and efficacy of zandelisib in combination with rituximab versus standard immunochemotherapy in patients with relapsed or refractory follicular or marginal zone lymphomas who received at least one prior line of therapy. Eligible patients must have received an anti-CD20 antibody in combination with chemotherapy or lenalidomide.

Title: A Novel Isoflavone, ME-344, Enhances Venetoclax Antileukemic Activity Against AML Via Suppression of Oxidative Phosphorylation and Purine Biosynthesis
Authors: Katie Hurrish, et. al.
Date: Sunday, December 12, 2021, 6:00 PM - 8:00 PM ET
Abstract ID: 2238

Summary of results: preclinical studies evaluating the combination of ME-344 with venetoclax in AML cell lines, including those with cytarabine resistance, and in an AML patient sample, suggest that ME-344 suppresses OXPHOS and the purine biosynthesis pathway to enhance the antileukemic activity of venetoclax against AML.

Title: A Phase 1 Dose-Escalation Study of the Oral CDK Inhibitor Voruciclib in Patients with Relapsed/Refractory B-Cell Malignancies or Acute Myeloid Leukemia (AML): Preliminary Results of the Completed Dose Escalation Stage in AML
Authors: Marina Konopleva, M.D., Ph.D., et. al.
Date: Monday, December 13, 2021, 6:00 PM - 8:00 PM ET
Abstract ID: 3423

Summary of conclusions: voruciclib administered on an optimized schedule of 14 consecutive days in a 28-day cycle was well tolerated. Further, no dose limiting toxicities were observed and no significant myelosuppression was seen in patients with B-cell malignancies, suggesting no overlapping toxicities with venetoclax. Disease stabilization was observed in heavily pretreated patients and differentiation syndrome was observed in AML patients indicating biologic activity. A protocol amendment is forthcoming to evaluate voruciclib in combination with venetoclax in patients with relapsed AML.

The abstracts are available on the ASH annual meeting website. The e-poster presentations will be available on the MEI Pharma website on the morning each poster opens for viewing at ASH.

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.

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.

MEI Pharma Contacts

David A. Walsey

MEI Pharma

Tel: 858-369-7104

investor@meipharma.com

Jason I. Spark

Canale Communications for MEI

Tel: 619-849-6005

jason.spark@canalecomm.com

Source: MEI Pharma, Inc.

FAQ

What abstracts will MEI Pharma present at the ASH Annual Meeting?

MEI Pharma will present three abstracts, including studies on zandelisib, ME-344, and voruciclib.

When is the ASH Annual Meeting where MEI Pharma will present?

The ASH Annual Meeting will take place from December 11 to 14, 2021.

What is the significance of the COASTAL study by MEI Pharma?

The COASTAL study investigates zandelisib's efficacy compared to standard treatment for patients with relapsed indolent non-Hodgkin’s lymphoma.

What results were reported for ME-344 in the ASH abstracts?

ME-344 was found to enhance venetoclax's antileukemic activity against AML through oxidative phosphorylation suppression.

What are the preliminary findings of the voruciclib study?

Voruciclib was well tolerated without significant toxicities, with disease stabilization observed in heavily pretreated patients.

MEI Pharma, Inc.

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