Announcement • Apr 12
MEI Pharma, Inc. Announces Strategic Plan to Leverage Recent Positive Voruciclib and ME-344 Clinical Data
MEI Pharma, Inc. reported that the Company’s Board of Directors unanimously agreed on a strategic plan to leverage recent positive voruciclib and ME-344 clinical data to prioritize clinical development of voruciclib while enabling development of a new ME-344 formulation for Phase 1 study. Additionally, the Company’s Board of Directors unanimously determined not to proceed with a second return of capital under the October 31, 2023 Anson Funds and Cable Car Capital cooperation agreement in order to conserve resources and align strategic investment, and thereby extend the Company’s operational runway. As previously disclosed, the Company’s October 31, 2023 Cooperation Agreement with stockholders, including Anson Funds and Cable Car Capital, provided that a potential second return of capital could be authorized by the Board under certain circumstances as outlined in that agreement, subject to the exercise of the Board’s fiduciary duties. Since data reported from Cohort 1 of the Phase 1b study exceeded a criterion for the potential second return of capital stated in the Agreement, the trigger for a return of capital was not met. The Board further unanimously determined, after deciding not to proceed with Cohort 2, that in the exercise of its fiduciary duties under applicable law, and in light of its views on what path is in the best interests of the Company’s stockholders, the Company would not proceed with any additional potential return of capital as permitted under the Cooperation Agreement. The strategy unanimously approved by the MEI Board of Directors provides for advancing clinical development of voruciclib, an investigational selective oral cyclin-dependent kinase 9 (“CDK9”) inhibitor, to new value inflection points by the end of calendar year 2025 and for enabling a new formulation of ME-344, an investigational inhibitor of mitochondrial oxidative phosphorylation (“OXPHOS”). The plan builds on encouraging recently reported voruciclib clinical data and ME-344 data separately reported . Specifically with respect to voruciclib, the development objective is to optimize voruciclib for a Phase 3 study in combination with venetoclax (Venclexta®) in patients with relapsed and refractory (“R/R”) acute myeloid leukemia (“AML”). Under the plan, the ongoing voruciclib development strategy will be guided by future clinical trial results and applicable regulatory authority advice. Subject to positive Phase 1 data later this year, MEI plans to amend the ongoing Phase 1 study to add a Phase 2 study arm, with enrollment in the Phase 2 arm anticipated to begin in 2025. This is anticipated to generate Phase 2 data by the end of 2025. Contingent on the success of the Phase 1/2 study, MEI plans to have the program ready to initiate a Phase 3 registration trial during 2026. With regards to ME-344, the plan is to develop a new formulation for further clinical development to better leverage the opportunity to advance a novel approach to inducing synthetic lethality in tumors in combination with VEGF inhibitors such as bevacizumab (Avastin®). The Company has already initiated research and development activity of the new formulation with encouraging results, with the goal of increasing biological activity, improving convenience of administration and increasing commercial opportunity. Interrupting ME-344 clinical activity and developing a new formulation will immediately reduce ME-344 expenditures. The Company recently reported initiation of enrollment in an expansion cohort of the ongoing Phase 1 study evaluating voruciclib plus venetoclax (Venclexta®), a B-cell lymphoma 2 (“BCL2”) inhibitor, in R/R AML. The decision to open the expansion cohort was based on encouraging initial data demonstrating anti-leukemic activity, including complete responses in heavily pretreated patients. Additionally, at doses of 100 mg or more, initial results from correlative biomarker assay analyses of available samples from patients treated with the combination demonstrated anticipated decreases of myeloid leukemia cell differentiation protein (“Mcl-1”), including a greater decrease in Mcl-1 at higher doses. Reductions in Mcl-1 are consistent with the known mechanism of action of CDK9. Further, there was no evidence of overlapping toxicity with venetoclax and no dose limiting toxicities were observed. Increasingly, venetoclax is being used as a standard treatment in patients with AML, but salvage therapy after venetoclax failure is common and yields limited benefit; only about 10% of patients respond to salvage therapy after venetoclax failure, representing a significant need for patients with AML. While mutation specific therapies, such as FLT3, IDH, and menin inhibitors, may be used in patients with such mutations, the majority of patients with AML do not have therapeutically actionable mutations. Thus, inhibition of CDK9 is a mutation agnostic therapeutic opportunity across the majority of patients with R/R AML, representing an addressable patient population larger than that of any mutation specific therapy. As separately reported, based on initial study results, 25% of evaluable patients with relapsed metastatic colorectal cancer (“mCRC”) enrolled in Cohort 1 of the ongoing Phase 1b study evaluating ME-344 in combination with bevacizumab (Avastin®) reached a predetermined 16-week progression free survival (“PFS”) threshold, exceeding the 20% threshold set in the Clinical Study Protocol. Patients were heavily pretreated and had failed standard therapies for their disease. The combination was also observed to have a generally well-tolerated safety profile. The recently reported data represent new clinical support of the potential of ME-344 in combination with VEGF inhibitors such as bevacizumab to induce synthetic lethality in tumors; this is a novel therapeutic strategy to potentially provide benefit to patients in a well-tolerated manner. Further, there is a significant medical need to provide patients with colorectal cancer new treatment options in light of the fact that deaths from this disease are a leading cause of cancer-related deaths in the U.S. and given that the incidence of colorectal cancer is increasing among those under 55. While the threshold was met to proceed to Cohort 2, the Company believes the best approach to meet the need of patients with mCRC, and potentially patients with other cancers where VEGF inhibitors are standard-of-care, is to continue to advance ME-344 via development of a new formulation, building upon the ME-344 results to date. The Company believes that development of a new formulation represents the optimal approach to leveraging the potential of the program and the novel therapeutic strategy to induce synthetic lethality in tumors via the combination.