GlycoMimetics to Present New Preclinical Data for GMI-1271 and GMI-1359 at AACR Annual Meeting 2018
March 14 2018 - 5:55PM
Business Wire
- Data supports expanding use of GMI-1271
in patients with AML who are unfit for chemotherapy
- GMI-1359 shows potential in treating
osteosarcoma and other cancers
GlycoMimetics, Inc. (NASDAQ: GLYC) announced today that
preclinical research suggesting the potential of two of its drug
candidates, GMI-1271 and GMI-1359, as treatments for acute myeloid
leukemia (AML), metastasis in osteosarcoma and other cancers will
be shared via poster presentations at the American Association for
Cancer Research (AACR) Annual Meeting 2018 in Chicago. The company
and its collaborators at the National Cancer Institute will
highlight data from preclinical models of selected cancers in which
GMI-1271, an antagonist of E-selectin, and GMI-1359, a dual
antagonist of E-selectin and CXCR4, exhibited anti-cancer
activity.
Key findings from the preclinical research include:
- GMI-1271 could potentially be used with
a hypomethylating agent, such as 5-azacitidine, to treat AML
patients not healthy enough for intensive chemotherapy.
- In preclinical models, GMI-1359
mobilized tumor-reactive T-cells from bone marrow, which could
enhance effectiveness of treatments despite tumor resistance.
- Both tumor growth and metastasis of
osteosarcoma to lung tissue are reduced with GMI-1359
treatment.
“We are delighted to be able to share new data on potential
expanded uses of our candidates GMI-1271 and GMI-1359 at the 2018
AACR Annual Meeting,” noted John Magnani, Ph.D.,
GlycoMimetics Senior Vice President and Chief Scientific
Officer. “The new preclinical studies indicate a greater range
of opportunities to potentially use our drug candidates to treat
AML patients unable to withstand intensive chemotherapy, and also
potentially to treat other cancers, such as osteosarcoma, that have
resisted other therapies. In addition, the mechanism of action of
our drug candidates may contribute to their use in immunotherapy.
The AACR data is also supportive, in particular, of the clinical
trial we expect the Haemato Oncology Foundation for
Adults in the Netherlands (HOVON) group to initiate,
in which HOVON researchers will evaluate GMI-1271 in adults with
newly diagnosed AML who cannot tolerate intensive chemotherapy, as
well as in patients with myelodysplastic syndrome (MDS) with a high
risk of leukemia.”
Details of the AACR presentations include:
Abstract #3514—Smith, T.A.G., et al. “Glycomimetic
antagonist of E-selectin, GMI-1271, enhances therapeutic activity
of the hypomethylating agent 5-azacitidine in the KG1 model of
AML.” Monday, April 16, 1:00-5:00 p.m. CT.
Abstract #5435—Fogler, W.B., et al. "Mobilization of
tumor-primed, marrow infiltrating lymphocytes into peripheral blood
with inhibitors of E-selectin or E-selectin and CXCR4." Monday,
April 16, 8:00 a.m.-12:00 p.m. CT.
Abstract #6334—Ju, W., et al. “Dual E-selectin and CXCR4
inhibition reduces tumor growth and metastatic progression in an
orthotopic model of osteosarcoma.” Wednesday, April 18, 8:00
a.m.-12:00 p.m. CT.
The AACR Annual Meeting 2018 takes place from April 14 to 18, at
the McCormick Place North/South, Chicago. Meeting abstracts are
available at AACR's website.
About GMI-1271
GMI-1271 is expected to enter Phase 3 clinical development in
the third quarter of 2018. The molecule 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 completed Phase 1/2
clinical trial, the results of which were presented at the ASH
2017 meeting , both newly diagnosed elderly and relapsed/refractory
patients with acute myeloid leukemia (AML) treated
with GMI-1271, 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, as well as lower than expected
induction-related mortality rates and incidence of severe
mucositis. Treatment in these patient populations was generally
well tolerated, with fewer than expected adverse effects.
About GMI-1359
GMI-1359 is currently in Phase 1 testing in healthy
volunteers. GMI-1359 is designed to simultaneously inhibit
both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion
molecules that keep cancer cells in the bone marrow and affect
cancer cell trafficking. 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.
About GlycoMimetics
GlycoMimetics is a clinical-stage biotechnology company
focused on the discovery and development of novel glycomimetic
drugs to address unmet medical needs resulting from diseases in
which carbohydrate biology plays a key role. GlycoMimetics' most
advanced drug candidate, rivipansel, a pan-selectin antagonist, is
being developed for the treatment of vaso-occlusive crisis in
sickle cell disease and is being evaluated in a Phase 3 clinical
trial conducted by GlycoMimetics’ strategic collaborator, Pfizer,
with preliminary data expected in the second half of 2018. The
FDA granted Breakthrough Therapy designation
for the company’s wholly owned drug candidate, GMI-1271,
an E-selectin antagonist, for treatment of adult AML patients
with relapsed/refractory disease; a Phase 3 clinical trial is
planned to initiate in the third quarter of
2018. GMI-1271 is also being
evaluated in an ongoing Phase 1 clinical trial for
the treatment of multiple myeloma. GlycoMimetics has also
initiated a Phase 1 clinical trial with a third 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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding
the clinical development of GMI-1271 and GMI-1359, including the
expected timing of completion of clinical trials and the
presentation of pre-clinical data. Actual results may differ
materially from those 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 that
was filed with the U.S. Securities and Exchange Commission (SEC) on
March 6, 2018, 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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GlycoMimetics, Inc.Investor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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