MEI Pharma to Present Design of Ongoing Clinical Study Evaluating ME-344 at ASCO GI Cancers Symposium 2024
16 Janeiro 2024 - 7:00PM
Business Wire
– Ongoing Phase 1b Study Evaluating ME-344 Plus
Avastin® in Patients with Metastatic Colorectal Cancer: Combination
Intended to Create Metabolic Synthetic Lethality –
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
announced the design of the ongoing Phase 1b study of the
mitochondrial oxidative phosphorylation (OXPHOS) inhibitor ME-344
in combination with bevacizumab (Avastin®) in refractory metastatic
colorectal cancer patients will be presented during a poster
session at the 2024 ASCO Gastrointestinal Cancers Symposium to be
held January 18 – 20, 2024.
Presentation Title: A Phase 1b Study of the OXPHOS
Inhibitor ME-344 in Combination with Bevacizumab in Refractory
Metastatic Colorectal Cancer Session Title: Trials in
Progress Poster Session C: Cancers of the Colon, Rectum, and Anus
Presenter: Patrick M. Boland Date: Saturday, January
20, 2024, 6:30-7:45 AM (Pacific Time) Abstract Number:
TPS222
The poster can be viewed on the MEI Pharma website here:
https://meipharma.com/ASCO2024enocuyg.html#
About the Phase 1b Study
The ongoing Phase 1b study is evaluating ME-344 plus bevacizumab
across two cohorts in patients with metastatic colorectal cancer
after failure of standard therapies. The combination of ME-344 and
bevacizumab is intended to create metabolic synthetic lethality by
leveraging the ability of antiangiogenics like bevacizumab to
reduce glycolysis, forcing tumors to switch to mitochondrial
respiration via OXPHOS, which is inhibited by ME-344.
In the first cohort of approximately 20 patients ME-344 is
administered at 10 mg/kg once weekly for 3 weeks in combination
with bevacizumab every two weeks, with cycles repeated every 4
weeks. If the rate of non-progression in Cohort 1 reaches a
predetermined progression free survival threshold, Cohort 2 will
enroll an additional 20 patients. Patients will be treated until
disease progression or intolerability. The primary endpoint of the
study is progression free survival. Secondary endpoints include
overall response rate, duration of response, overall survival and
safety.
The study is being conducted at member centers of the Academic
GI Cancer Consortium (AGICC), an oncology consortium dedicated to
identifying new drugs to treat gastrointestinal (GI) cancers.
About ME-344
ME-344 is a novel drug candidate that inhibits mitochondrial
oxidative phosphorylation (OXPHOS), a fundamental metabolic pathway
involved in the production of adenosine triphosphate (ATP) in the
mitochondria. ATP provides energy to drive many metabolic cell
processes, including division, proliferation, and growth. By
disrupting the production of ATP, ME-344 has been shown to induce
cancer cell death in nonclinical models and was associated with
antitumor activity in clinical studies.
The two main sources of ATP production in cells are OXPHOS and
glycolysis; the latter is highly active in most tumors.
Anti-angiogenics, like the vascular endothelial growth factor
(VEGF) inhibitor bevacizumab (AVASTIN®), have the potential to
normalize vasculature and decrease reliance on glycolysis. The
resulting reduction in glycolysis may trigger an increased
dependence on mitochondrial ATP production for energy to support
continued tumor proliferation.
In such cases of tumor plasticity, the combination of ME-344 and
bevacizumab may induce metabolic synthetic lethality, providing a
novel therapeutic strategy. Specifically, leveraging the ability of
antiangiogenics like bevacizumab to reduce glycolysis and force
tumor cells to switch to mitochondrial respiration via OXPHOS,
which is inhibited by ME-344, may reduce access to ATP needed for
cell division and growth in tumors.
This approach was first clinically evaluated in a multicenter,
investigator-initiated, randomized, open-label, window of
opportunity clinical study, evaluating ME-344 (3 doses) plus
bevacizumab (1 dose) in 42 women with early HER2-negative breast
cancer. Study results demonstrated significant biological antitumor
activity as measured by a reduction in the proliferative biomarker
Ki-67 compared to placebo. The combination appeared to be generally
well tolerated. The data from this study were consistent with
preclinical data suggesting that combining ME-344 can augment
anti-angiogenic therapy and provided validation for continued
evaluation of the combination of ME-344 with bevacizumab and other
VEGF inhibitors.
An earlier Phase 1 clinical study evaluating ME-344 as a
single-agent in patients with refractory solid tumors also
demonstrated anti-tumor activity, further validating the potential
of mitochondrial inhibition as a promising therapeutic
modality.
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, an
intravenous small molecule mitochondrial inhibitor targeting the
oxidative phosphorylation pathway. 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/20240116948064/en/
David A. Walsey MEI Pharma Tel: 858-369-7104
investor@meipharma.com
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