GlycoMimetics’ Uproleselan in Combination With Venetoclax/HMA Shown to Break Chemoresistance, Reduce Tumor Burden & Increas...
December 05 2020 - 6:00PM
Business Wire
GlycoMimetics exploring investigator-sponsored
follow-up human studies
Oral presentation at 62nd ASH Annual Meeting
and Exposition points to potential role for uproleselan as
foundational therapy in acute myeloid leukemia (AML)
GlycoMimetics’ (Nasdaq: GLYC) product candidate uproleselan —
when added to a combination therapy of venetoclax and a
hypomethylating agent (HMA) — was shown today in an oral
presentation to break chemoresistance by dramatically and
significantly reducing tumor burden as detected by circulating
human AML cells after three weeks of treatment, and by
significantly increasing survival (p = 0.0009) in an animal model
engrafted with AML from a patient with acquired resistance to
venetoclax/HMA combination therapy. The oral presentation made by
Dr. Kyung Hee Chang, Department of Leukemia, Division of Cancer
Medicine, The University of Texas MD Anderson Cancer Center, at the
62nd ASH Annual Meeting and Exposition supports the need for
further clinical investigation to potentially extend the use of
uproleselan, an investigational, first-in-class, targeted
E-selectin antagonist, to other drug combinations and, in
particular, to venetoclax/HMA.
“As in previously reported models, uproleselan has shown benefit
when added to multiple chemotherapy regimens. These data, showing
the potential benefit of adding uproleselan to a combination
therapy of venetoclax and HMA, are important given the rapid
changes in the landscape of approved AML therapies as well as those
in development. The data strongly support conducting a clinical
trial with this combination therapy,” said Rachel King,
GlycoMimetics’ Chief Executive Officer.
“Given investigator interest in this data, we’re actively
exploring opportunities for investigator-sponsored clinical trials
to study the implications in humans. If successful, these studies
would further reinforce our goal of demonstrating the value of
uproleselan across the spectrum of AML patients and with a variety
of therapeutic combination regimens,” she added.
GlycoMimetics previously presented preclinical data showing that
hypomethylating agents up-regulate the expression of E-selectin
ligand on AML cells. The Company believes E-selectin upregulation
increases the binding affinity of the blasts to the vascular
endothelium, where E-selectin is expressed, and as a result,
contributes to increased chemoresistance. By antagonizing
E-selectin’s role in this cascade, GlycoMimetics believes
uproleselan may be able to play a key role in deepening patient
responses to or enhancing the duration of efficacy of
venetoclax/HMA combinations.
Details on this presentation are as follows:
Title: Targeting E-selectin with GMI-1271 Overcomes
Microenvironment-mediated Resistance to Venetoclax/HMA Therapy.
Presenters: Kyung Hee Chang, Muharrem Muftuoglu, Weiguo
Zhang, Mahesh Basyal, Lauren Ostermann, William E. Fogler, John L.
Magnani and Michael Andreeff. Session: 604 Molecular
Pharmacology and Drug Resistance in Myeloid Diseases. Date and
Time: Saturday, December 5, 2020. 5:00 - 8:30 p.m. ET
Presentation Time: 6:15 p.m. ET
About Uproleselan (GMI-1271)
Discovered and developed by GlycoMimetics, uproleselan is an
investigational, first-in-class, targeted E-selectin antagonist.
Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive
Phase 3 development program in AML, has received Breakthrough
Therapy designation from the U.S. FDA for the treatment of adult
AML patients with relapsed or refractory disease. Uproleselan is
designed to block E-selectin (an adhesion molecule on cells in the
bone marrow) from binding with blood cancer cells as a targeted
approach to disrupting well-established mechanisms of leukemic cell
resistance within the bone marrow microenvironment. In a Phase 1/2
clinical trial, uproleselan was evaluated in both newly diagnosed
elderly and relapsed or refractory patients with AML. In both
populations, patients treated with uproleselan together with
standard chemotherapy achieved better-than-expected remission rates
and overall survival compared to historical controls, which have
been derived from results from third-party clinical trials
evaluating standard chemotherapy, as well as lower-than-expected
induction-related mortality rates. Treatment in these patient
populations was generally well-tolerated, with fewer than expected
adverse effects.
About GlycoMimetics, Inc.
GlycoMimetics is a biotechnology company with two late-stage
clinical development programs and a pipeline of novel glycomimetic
drugs, all designed to address unmet medical needs resulting from
diseases in which carbohydrate biology plays a key role.
GlycoMimetics' drug candidate, uproleselan, an E-selectin
antagonist, was evaluated in a Phase 1/2 clinical trial as a
potential treatment for AML and is being evaluated across a range
of patient populations including a Company-sponsored Phase 3 trial
in relapsed/refractory AML under Breakthrough Therapy designation.
Rivipansel, a pan-selectin antagonist, is being explored for use in
treatment of acute vaso-occlusive crisis in sickle cell disease.
GlycoMimetics has also completed a Phase 1 clinical trial with
another wholly-owned drug candidate, GMI-1359, a combined CXCR4 and
E-selectin antagonist. GlycoMimetics is located in Rockville, MD in
the BioHealth Capital Region. Learn more at
www.glycomimetics.com.
Forward-Looking Statements
This press release contains forward-looking statements. These
forward-looking statements include those relating to the planned or
potential clinical development of the Company’s product candidates,
including the presentation of data from preclinical studies and
clinical trials and the potential benefits and impact of the
Company’s drug candidates. Actual results may differ materially
from those described in these forward-looking statements. For a
further description of the risks associated with these statements,
as well as other risks facing GlycoMimetics, please see the risk
factors described in the Company’s annual report on Form 10-K filed
with the U.S. Securities and Exchange Commission (SEC) on February
28, 2020, and other filings GlycoMimetics makes with the SEC from
time to time. Forward-looking statements speak only as of the date
of this release, and GlycoMimetics undertakes no obligation to
update or revise these statements, except as may be required by
law.
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