MEI Pharma Announces Acceptance of Abstract for Presentation at ASH 2023
02 November 2023 - 2:00PM
Business Wire
MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical
company focused on advancing new therapies for cancer, today
announced that an abstract highlighting clinical data from the
monotherapy dose escalation stage of the ongoing Phase 1 study
evaluating voruciclib, a selective oral cyclin-dependent kinase 9
(CDK9) inhibitor, alone and in combination with venetoclax
(Venclexta®), a B-cell lymphoma 2 ("BCL2") inhibitor, in patients
with acute myeloid leukemia (AML) or B-cell malignancies, will be
presented during a poster session at the upcoming 65th American
Society of Hematology (ASH) Annual Meeting and Exposition to be
held December 9 – 12, 2023.
Presentation Title: A Phase 1 Study of the Oral CDK9
Inhibitor Voruciclib in Relapsed/Refractory (R/R) B-Cell Lymphoma
(NHL) or Acute Myeloid Leukemia (AML) Session Title: Acute
Myeloid Leukemias: Investigational Therapies, Excluding
Transplantation and Cellular Immunotherapies: Poster III (616)
Presenter: Mathew Davids, MD, MMSc., Director, Clinical
Research, Division of Lymphoma, Dana Farber Cancer Institute
Date: Monday, December 11, 2023, 6:00-8:00 PM (Pacific Time)
Publication Number: 4286
About the Phase 1 Study
The Phase 1 study is a two stage, open-label, 3+3 dose
escalation and expansion study evaluating voruciclib, a CDK9
inhibitor, as a monotherapy and in combination with venetoclax
(marketed as Venclexta®), a BCL2 inhibitor. Inhibition of CDK9
blocks the production of Mcl-1, which is an established resistance
mechanism to the BCL2 inhibitor venetoclax. The primary objectives
of the study are to determine the safety and biologic effective
dose of voruciclib monotherapy or voruciclib in combination with
venetoclax. Secondary objectives of the study include assessing the
preliminary efficacy, pharmacokinetics, pharmacodynamics, and
biomarkers of voruciclib monotherapy or voruciclib in combination
with venetoclax.
The first stage of the study, evaluating the dose and schedule
of voruciclib as a single-agent in patients with relapsed and
refractory (“R/R”) acute myeloid leukemia (“AML”) or B-cell
malignances after failure of standard therapies, is now completed
and the final results presented in the abstract. Stage 2 of the
study is evaluating voruciclib in combination with standard dose
venetoclax in patients with R/R AML.
About Voruciclib
Voruciclib is an orally administered cyclin-dependent kinase 9
(“CDK9”) inhibitor with potential to treat both hematological
malignancies and solid tumors. It is in clinical development for
acute myeloid leukemia and B-cell malignancies. Applications in
solid tumors are also being considered.
The CDK family of proteins are important cell cycle regulators
responsible for the control of cell proliferation, differentiation,
apoptosis, and DNA repair. CDK9, one of several members of the CDK
family of proteins, functions as a gene transcription controller
and is also involved in regulating protein degradation.
Specifically, CDK9 is a promising target to treat a range of
cancers because of its role in controlling two other proteins often
dysregulated in cancerous cells: myeloid leukemia cell
differentiation protein ("Mcl-1") and the MYC proto-oncogene
protein ("MYC")
Mcl-1 is a member of the family of anti-apoptotic proteins
which, when elevated, may prevent the cell from undergoing cell
death. Inhibition of CDK9 blocks the production of Mcl-1, which is
an established resistance mechanism to the B-cell lymphoma 2
("BCL2") inhibitor venetoclax (marketed as Venclexta®).
MYC regulates cell proliferation and growth. Upregulation of MYC
is implicated in many human cancers and is frequently associated
with poor prognosis and unfavorable patient survival. CDK9, in
addition to being a transcription factor for MYC, also decreases
phosphorylation of MYC protein that is implicated in stabilizing
MYC in KRAS mutant cancers. Targeting MYC directly has historically
been difficult, but CDK9 is a promising approach to target this
oncogene.
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. 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; 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; the impact of geopolitical tensions, 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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MEI Pharma Contacts: David A. Walsey MEI Pharma Tel:
858-369-7104 investor@meipharma.com
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