MEI Pharma, Inc. (NASDAQ: MEIP), a clinical-stage pharmaceutical
company focused on advancing new therapies for cancer, today
announced the dosing of the first patient in a Phase 1b study
evaluating ME-344 in combination with bevacizumab (AVASTIN®) in
patients with previously treated metastatic colorectal cancer.
ME-344 is a novel mitochondrial inhibitor targeting energy
production through the OXPHOS pathway, which is important for
supporting tumor cell survival and proliferation for many forms of
cancer, including colorectal cancer. Bevacizumab, a vascular
endothelial growth factor (VEGF) inhibitor, and other
antiangiogenics, increase reliance on mitochondrial energy
production, thereby providing an important opportunity to evaluate
a combination with a mitochondrial inhibitor like ME-344 to inhibit
energy production in tumor cells and induce an antitumor
effect.
“As one of the most commonly diagnosed cancers, and a leading
cause of cancer-related deaths in both men and women in the United
States, there is a high medical need for new therapies to treat
colorectal cancer, particularly for patients who have failed
standard therapy and have metastatic disease,” stated Dr Howard
Hochster, Distinguished Professor, and Director, GI Oncology,
Rutgers Cancer Institute. “This clinical study presents an
important opportunity to evaluate a novel approach to treatment
with the potential to bring improved benefit to patients. This
target is quite unlike other treatments for colorectal cancer, and
will be studied by investigators at the Rutgers Cancer Institute
Metabolomics Center of Excellence in conjunction with the trial. We
are excited to join with our colleagues nationally in the Academic
GI Cancer Consortium (AGICC) to investigate this promising
agent.”
“We are excited to continue to pioneer the evaluation of
mitochondrial inhibition as a promising approach to treat solid
tumors with the initiation of this innovative study evaluating
ME-344, our mitochondrial inhibitor, in combination with
bevacizumab in patients with colorectal cancer who progressed after
standard therapies,” said Richard Ghalie, M.D., chief medical
officer, of MEI Pharma. “With the current study, we look forward to
the opportunity to build on both mechanistic and efficacy data from
earlier pre-clinical and clinical studies demonstrating the
anti-tumor activity of ME-344 in combination with bevacizumab.”
The Company anticipates announcing safety and efficacy data from
the first cohort of 20 ME-344 patients in the first half of
2024.
About the Phase 1b Study
The Phase 1b study is evaluating ME-344 plus bevacizumab across
two cohorts in patients with metastatic colorectal cancer after
failure of standard therapies. Twenty patients will be enrolled in
the first cohort and receive ME-344 at 10 mg/kg once weekly in
combination with bevacizumab every two 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 who will receive ME-344 every 2 weeks to match bevacizumab
infusion frequency. 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.
About ME-344
ME-344 is a novel mitochondrial inhibitor drug candidate that
has demonstrated tumor selective activity in pre-clinical studies.
It targets the OXPHOS pathway involved in the production of
adenosine triphosphate, or ATP. Energy supplied in the form of ATP
fuels tumor metabolism supporting cell division and growth. By
disrupting the production of ATP, ME-344 has been shown
pre-clinically to induce cancer cell death through the induction of
DNA fragmentation and through a process known as destructive
autophagy, whereby a cell consumes itself. ME-344 has also
demonstrated evidence of antitumor activity in preclinical and
clinical studies.
The two major sources of ATP are the mitochondria and
glycolysis, a process that breaks down glucose. It is understood
that anti-angiogenics, like the vascular endothelial growth factor
(VEGF) inhibitor bevacizumab (AVASTIN®), may reduce the rate of
glycolysis in tumors as a mechanism to slow tumor growth. However,
tumor metabolism may then shift to mitochondrial metabolism for
energy production to support continued tumor proliferation. In such
cases of tumor plasticity in the presence of treatment with
anti-angiogenics, contemporaneously targeting the alternative
metabolic source by inhibiting ATP production with the
mitochondrial drug inhibitor ME-344, may open an important
therapeutic opportunity.
In a multicenter, investigator-initiated, randomized,
open-label, window of opportunity clinical study, ME-344 (3 doses)
plus bevacizumab (1 dose) was evaluated in 42 women with early
HER2-negative breast cancer. Study results demonstrated significant
biological antitumor activity in HER2-negative breast cancer
patients as measured by reductions 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 ME-344 can reverse resistance to
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 Colorectal Cancer
Colorectal cancers generally start as growths, called polyps, on
the inner lining of the colon or rectum. If cancer forms in a
polyp, it can grow into the wall of the colon or rectum over time,
and then grow into blood vessels or lymph vessels that can allow
the cancer to spread across the body. Metastatic colorectal cancer
is a colorectal cancer that has already spread to other parts of
the body.
Excluding skin cancers, colorectal cancers are the third most
common cancer diagnosed in both men and women in the United States.
It is estimated that approximately 150,000 patients will be
diagnosed with colorectal cancers in the United States in 2023.
Colorectal cancer is the second most common cause of cancer deaths
in the U.S., with approximately 52,550 deaths expected during
2023.*
Treatment of colorectal cancer may include a combination of
chemotherapy, targeted therapy, immunotherapy, surgery, and
radiation therapy, which can be used to slow the spread of the
disease and shrink a cancerous tumor.**
*American Cancer Society, Cancer.org (accessed July 26, 2023);
**American Society of Clinical Oncology, Cancer.Net (accessed July
26, 2023).
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a pharmaceutical company
focused on developing potential new therapies for cancer. MEI
Pharma’s portfolio of drug candidates includes clinical stage
candidates with differentiated mechanisms of action intended to
address unmet medical needs and deliver improved benefit to
patients 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
Certain information contained in this press release includes
“forward-looking statements,” within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. 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. Our forward-looking statements
are based on current beliefs and expectations of our management
team that involve risks, potential changes in circumstances,
assumptions, and uncertainties, including our expectations
regarding the effect of the reverse stock split, our ability to
meet the minimum bid price requirement, our ability to regain
compliance with the Nasdaq continued listing requirements, and our
financial condition, growth and strategies. Any or all of the
forward-looking statements may turn out to be wrong or be affected
by inaccurate assumptions we might make or by known or unknown
risks and uncertainties. These forward-looking statements are
subject to risks and uncertainties including risks related to our
ability to regain compliance with Nasdaq’s minimum bid price
requirement, or otherwise maintain compliance with any other
listing requirements on Nasdaq, the potential de-listing of our
shares on Nasdaq, our strategy, business plans and focus, and the
other risks set forth in our filings with the U.S. Securities and
Exchange Commission, including our Annual Report on Form 10-K and
our Quarterly Reports on Form 10-Q. For all these reasons, actual
results and developments could be materially different from those
expressed in or implied by our forward-looking statements. You are
cautioned not to place undue reliance on these forward-looking
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release. We undertake no obligation to publicly update such
forward-looking statements to reflect subsequent events or
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David A. Walsey 858-369-7104 investor@meipharma.com
Joele Frank, Wilkinson Brimmer Katcher Dan Katcher / Aaron
Palash 212-355-4449 MEIP-jf@joelefrank.com
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