– MEI Pharma Board Unanimously Determines,
Based on Clinical Data Results, Not to Proceed with Second Capital
Return Under 2023 Anson and Cable Car Cooperation Agreement:
Conserving Capital, Prioritizing Measured Investment, Extending
Operational Runway –
MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical
company evaluating novel drug candidates to address known
resistance mechanisms to standard-of-care cancer therapies, today
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.
“We are very fortunate as a development-stage therapeutics
company to have two very promising oncology candidates, voruciclib
and ME-344, that continue to generate data supporting their
potential as novel therapeutics to benefit patients with cancer.
With the MEI Board aligned around our strategy, we have a
productive framework to advance both clinical programs in a manner
intended to address significant medical needs while prioritizing a
measured and objective-based allocation of our resources,” said
David Urso, president and chief executive officer of MEI Pharma.
“Voruciclib, our investigational oral CDK9 inhibitor, in
combination with venetoclax is being developed to treat patients
with relapsed/refractory AML without an actionable mutation,
representing a potential opportunity to address more patients in a
mutation agnostic approach than mutation specific therapies such as
FLT3, IDH or menin inhibitors. In addition, investigational ME-344
has the potential to treat patients across many types of solid
tumors through a novel therapeutic strategy in combination with
VEGF inhibitors, such as Avastin®, to create synthetic lethality in
tumor cells.”
“The entire MEI Board is pleased to unanimously align around a
strategy that we believe is in the best interests of the Company’s
shareholders, with the intent to optimize the opportunity to
judiciously advance both of the voruciclib and ME-344 development
programs,” stated Taheer Datoo, director of MEI Pharma and
principal and portfolio manager of Anson Funds. “Under the
strategy, use of capital is measured and balanced to achieve key
clinical objectives designed to optimize the development potential
these product candidates hold to advance the standard of care for
patients with cancer while also optimizing the interests of our
shareholders.”
Mr. Datoo continued: “As we move forward, we have every
confidence that execution of the strategy is in good hands with the
MEI leadership team. They have significant experience in the
clinical development of oncology therapeutics and are well suited
to achieve success for patients and for the Company’s
shareholders.”
Return of Capital Determination
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.
Strategic Overview
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 today.
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.
Voruciclib
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.
ME-344
As separately reported today, 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. The goal of the
formulation effort is to increase biological activity, improve
patient convenience of administration and increase commercial
opportunity. This plan will reduce short-term expenditures on the
ME-344 program and ultimately, if successful, create an enhanced
formulation for continued clinical development
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a clinical-stage
pharmaceutical company committed to developing novel and
differentiated cancer therapies. We build our pipeline by acquiring
promising cancer agents and creating value in programs through
development, strategic partnerships, out-licensing and
commercialization, as appropriate. Our approach to oncology drug
development is to evaluate our drug candidates in combinations with
standard-of-care therapies to overcome known resistance mechanisms
and address clear medical needs to provide improved patient
benefit. The drug candidate pipeline includes voruciclib, an oral
cyclin-dependent kinase 9 ("CDK9") inhibitor, and ME-344, a novel
small molecule inhibitor of mitochondrial oxidative phosphorylation
(OXPHOS). For more information, please visit www.meipharma.com.
Follow us on X (formerly Twitter) @MEI_Pharma and on LinkedIn.
Forward-Looking Statements
Certain information contained 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, without limitation,
statements regarding: the potential, safety, efficacy, and
regulatory and clinical progress of our product candidates,
including the anticipated timing for initiation of clinical trials
and release of clinical trial data and our expectations surrounding
potential regulatory submissions, approvals and timing thereof, our
business strategy and plans; the sufficiency of our cash, cash
equivalents and short-term investments to fund our operations; and
our ability to fund future capital returns. 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, or
the failure to obtain such approval, of our product candidates;
uncertainties or differences in interpretation in clinical trial
results; uncertainty regarding the impact of rising inflation and
the increase in interest rates as a result; potential economic
downturn; geopolitical conflicts; activist investors; 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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240411560218/en/
David A. Walsey MEI Pharma Tel: 858-369-7104
investor@meipharma.com
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