MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that two posters presenting preclinical data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2022 for zandelisib, an orally administered phosphatidylinositol-3-kinase (PI3K) inhibitor, and ME-344, a tumor selective mitochondrial inhibitor.

“The preclinical data presented at AACR is supportive of the promise of our pipeline and we look forward to continuing to advance our clinical candidates in an effort to provide new therapeutic options for patients with cancer,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma.

To view the posters click here.

Title: Efficacy and immune profiling of the PI3K delta inhibitor zandelisib (ME-401) in a preclinical model of chronic lymphocytic leukemia (CLL)

Authors: Dr. Maharaj, et. al.

Date: Friday, April 8, 2022, 8:30 AM ET

AbstractID: 5496

Summary: Data from preclinical studies with zandelisib ex vivo in normal human T cells and in vivo in a murine CLL model suggest that zandelisib has immunomodulatory properties on human T cells. Zandelisib in combination with ibrutinib further reduced normal human T cell proliferation and inducible regulatory T cells (Tregs), while zandelisib alone decreased activation and expression of suppressive markers, such as PD-1 and CTLA-4 on inducible regulatory (Tregs) and CD4+ T cells, comparably to zandelisib/ibrutinib combination. In the murine CLL model, a reduction in Treg numbers, markers of terminal memory differentiation and T-cell exhaustion on CD4+ and CD8+ T cells – all of which are features that have been shown to permit CLL immune evasion – as well as improvement in overall survival was observed.

Title: ME-344, a novel isoflavone mitochondrial inhibitor, in combination with venetoclax constitutes a new metabolism-targeted approach to overcome resistance to Bcl-2 inhibition and standard of care treatment in AML

Authors: Katie Hurrish, et. al.

Date: Wednesday, April 13, 2022, 10:00 AM – 1:30 PM ET

AbstractID: 3785

Summary: ME-344 is an investigational isoflavone that has been shown to suppress OXPHOS in solid tumor cells. However, it has not been tested extensively in hematologic malignancies. This study analyzes the ability of ME-344 to enhance the activity of venetoclax against acute myeloid leukemia (AML). Data from the presented in vitro and in vivo preclinical studies evaluating the combination of ME-344 with venetoclax in standard-of-care-resistant AML cell lines and relapsed or refractory AML patient samples suggest that ME-344, both alone and in combination with venetoclax, inhibits purine biosynthesis, suppresses oxidative phosphorylation, induces apoptosis and decreases Mcl-1, which together target metabolic vulnerabilities of AML cells. The data demonstrated that ME-344 and venetoclax prolong survival in MV4-11- and MV4-11/AraC-R-derived xenograft AML models. Overall, it’s concluded that ME-344 enhances venetoclax activity against AML cells including resistant AML.

About Zandelisib

Zandelisib, a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. Clinical trials are investigating the efficacy and safety of zandelisib as a single agent and in combination with other modalities while administered on an Intermittent Dosing Regimen (IDT). The IDT leverages molecular and biologic properties specific to zandelisib.

Ongoing zandelisib studies include the Phase 2 TIDAL study (NCT03768505) evaluating patients with relapsed or refractory follicular and marginal zone lymphomas. Also ongoing is the Phase 3 COASTAL study (NCT04745832) comparing zandelisib plus rituximab to standard of care chemotherapy plus rituximab, in patients with relapsed or refractory follicular or marginal zone lymphomas who received more than one prior line of therapy, which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide. COASTAL is intended to support marketing applications in the U.S. and globally.

About ME-344

ME-344 is a novel and tumor selective mitochondrial inhibitor drug candidate. It directly targets the OXPHOS complex 1, a pathway involved in the production of adenosine triphosphate, or ATP, in the mitochondria. Treatment of tumor cells with ME-344 as a single-agent results in a rapid loss of ATP and cancer cell death.

Although clinical investigation of ME-344 has demonstrated single agent activity in patients with solid tumors, using it in combination with other cancers therapies is thought to hold more significant potential for patients. Data reported from an investigator-initiated, multi-center, randomized study of ME-344 in combination with the VEGF inhibitor bevacizumab (Avastin®) demonstrated biologic activity in the ME-344 treatment group supporting further clinical investigation.

A Phase 2 study of ME-344 plus Avastin in patients with relapsed colorectal cancer is planned to start towards the end of 2022.

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, 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.

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