- Data highlight the importance of early intervention with
E-selectin inhibitors to disrupt inflammatory mechanisms driving
acute vaso-occlusive crisis (VOC) in sickle cell disease (SCD)
- Additional presentations highlight multiple E-selectin
inhibition strategies and their potential to treat acute myeloid
leukemia (AML)
GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that three
abstracts including data from the Company’s clinical and research
portfolio have been accepted for oral presentations and two
abstracts have been accepted for poster presentations at the 62nd
American Society of Hematology (ASH) Annual Meeting and Exposition,
to be held virtually December 5-8, 2020.
Of particular note are primary and key secondary endpoint data
from additional analysis of the Phase 3 RESET study evaluating the
efficacy of rivipansel in VOC. These findings point to the
potential benefits, clinical improvements and improved outcomes
associated with early treatment with GlycoMimetics’ wholly-owned
product candidate, which include shorter hospital stays for
patients and reduced need for IV opioids to treat pain.
A second presentation includes data from two different
preclinical models of VOC using GlycoMimetics’ highly potent and
specific E-selectin antagonist, GMI-1687. This presentation will
highlight the product candidate’s potential for intravenous and
subcutaneous administration to treat VOC by inhibiting occlusions
and restoring blood flow.
A third presentation discloses how targeting E-selectin with
uproleselan may help patients with AML overcome resistance to
venetoclax combined with hypomethylating agent (HMA) based
therapy.
Poster presentations convey how GMI-1359, a rationally-designed
small molecule that inhibits E-selectin and CXCR4 (a chemokine
receptor), enhances sorafenib’s anti-leukemia effect in
pre-clinical AML models; and how GMI-1359 can uniquely generate
motility-enhancing signals in AML cells and deplete AML cells from
protective vascular niches in the bone marrow.
“GlycoMimetics is honored to have five abstracts from across our
product candidate portfolio selected for presentations at this
year’s ASH meeting. The data convey new insights into the critical
role of E-selectin in both malignant and inflammatory,
adhesion-mediated conditions, suggesting novel treatment options
for unmet need in sickle cell disease and AML,” said Helen
Thackray, MD, FAAP, GlycoMimetics’ Chief Medical Officer.
Details on GlycoMimetics presentations at the ASH Meeting are as
follows:
Title: Restoration of Normal Blood
Flow in Mouse Models of Sickle Cell Vaso-occlusion Following
Intravenous or Subcutaneous Administration of a Highly Potent
E-Selectin Specific Inhibitor. Presenters: Madhan
Thamilarasan, William E. Fogler, John L. Magnani and Rahima
Zennadi. Session: 113 Hemoglobinopathies, Excluding
Thalassemia—New Genetic Approaches to Sickle Cell Disease: New
Insights Into Sickle Cell Disease Pathophysiology. Date and
Time: December 5, 2020. 2:00 – 3:30 p.m. EST Presentation
Time: 2:45 p.m.
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.
2:00 - 3:30 p.m. Presentation Time: 3:15 p.m.
Title: Dual CXCR4 and E-selectin
Inhibition (GMI-1359) Rapidly Increases AML Cellular Motility Prior
to Intravasation and Vascular Niche Depletion Observed by
Intravital Bone Marrow 2-Photon Microscopy. Presenters:
Tomasz Zal, M. Anna Zal, Mateusz Rytelewski, Kyung Hee Chang,
Rodrigo Jacamo, William E. Fogler, John L. Magnani and Michael
Andreeff. Session: 616 Acute Myeloid Leukemia: Novel
Therapy, excluding Transplantation: Poster II. Date: Sunday,
December 6, 2020. Virtual Poster Hall: 7 a.m. – 3:30
p.m.
Title: Combined Blockage of E-selectin
and CXCR4 (GMI-1359) Enhances Anti-Leukemia Effect of FLT3
Inhibition (Sorafenib) and Protects Hematopoiesis in Pre-clinical
AML Models. Presenters: Weiguo Zhang, Kyung Hee Chang,
Mahesh Basyal, Yannan Jia, Lauren Ostermann, William E. Fogler,
John L. Magnani, M. Anna Zal, Tomasz Zal and Michael Andreeff.
Session: 616 Acute Myeloid Leukemia: Novel Therapy,
excluding Transplantation: Poster III. Date: Monday,
December 7, 2020. Virtual Poster Hall: 7 a.m. – 3:30
p.m.
Title: Early Initiation of Treatment
with Rivipansel for Acute Vaso-Occlusive Crisis in Sickle Cell
Disease (SCD) Achieves Earlier Discontinuation of IV Opioids and
Shorter Hospital Stay: Reset Clinical Trial Analysis
Presenter: Helen Thackray Session Name: 114
Hemoglobinopathies, Excluding Thalassemia—Clinical: Novel
Treatments for Sickle Cell Disease Date and Time: Monday,
December 7, 2020. 1:30 - 3:00 p.m. Presentation Time:
1:45 p.m.
The accepted abstracts are available online through the ASH
meeting website,
https://ash.confex.com/ash/2020/webprogram/start.html
About Rivipansel
Rivipansel, the company’s wholly-owned glycomimetic drug
candidate that binds to all three members of the selectin family
(E-, P- and L-selectin), was GlycoMimetics’ first candidate to
enter clinical development. After the Phase 3 RESET trial conducted
by Pfizer, GlycoMimetics’ former collaborator, did not meet its
primary or key secondary efficacy endpoints in 2019, new efficacy
data from an additional analysis of rivipansel were published in
June 2020 and subsequently presented at the Foundation for Sickle
Cell Disease Research Meeting in September 2020. GlycoMimetics is
engaging with the FDA to identify what, if any, next steps to take,
with a focus on determining if there is a potential streamlined
path forward for this asset in sickle cell disease.
About GMI-1687
Discovered and developed by GlycoMimetics, GMI-1687 is a
highly-targeted, highly-potent E-selectin antagonist. It has been
shown in preclinical studies to be bioavailable via subcutaneous
administration. At the 2018 Annual Meeting of the American Society
of Hematology, data presented in a poster about GMI-1687 pointed to
the potential for a life-cycle extension for GlycoMimetics’
uproleselan. The investigational drug has also been shown to
represent a more highly-potent and subcutaneously bioavailable
potential life-cycle extension for rivipansel.
About Uproleselan (GMI-1271)
Discovered and developed by GlycoMimetics, uproleselan is an
investigational, first-in-class, targeted inhibitor of E-selectin.
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 GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin
and CXCR4. E-selectin and CXCR4 are both adhesion molecules
involved in tumor trafficking and metastatic spread. Preclinical
studies indicate that targeting both E-selectin and CXCR4 with a
single compound could improve efficacy in the treatment of cancers
that involve the bone marrow such as AML and multiple myeloma or in
solid tumors that metastasize to the bone, such as prostate cancer
and breast cancer, as well as in osteosarcoma, a rare pediatric
tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy
volunteers. The Duke University Phase 1b clinical study in breast
cancer patients is designed to enable investigators to identify an
effective dose of the drug candidate and to generate initial
biomarker data around the drug’s activity. GMI-1359 has received
Orphan Drug Designation and Rare Pediatric Disease Designation from
the FDA for the treatment of osteosarcoma, a rare cancer affecting
about 900 adolescents a year in the United States.
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 acute myeloid leukemia (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 VOC in
SCD. 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 regarding
preclinical data, clinical development and potential benefits and
impact of the Company’s drug candidates. These forward-looking
statements include those relating to the planned or potential
clinical development of the Company’s product candidates, including
the Company’s engagement with regulatory authorities and the
presentation of data from preclinical studies and clinical trials.
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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Email: sannes@annesassociates.com
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Email: jamielacey@presscommpr.com
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