GlycoMimetics, Inc. (NASDAQ: GLYC) announced today that data from two
drug candidates in its pipeline, GMI-1271 and GMI-1359, will be featured
during one oral presentation and three poster sessions at the 57th
American Society of Hematology (ASH) Annual Meeting and Exposition. ASH
is being held December 5 to 8, 2015, in Orlando, Florida.
A series of studies, selected for an oral presentation at ASH,
demonstrated that GMI-1271 could be used to mobilize and enrich a
population of primitive T cells known as T memory stem (Tscm) or T
central memory (Tcm) cells. These Tscm/cm cells are known to have
greater reconstitution and survival properties making them ideal for use
in adoptive T-cell therapy, including engineered CAR-T approaches. GMI-1271,
an antagonist to the cell adhesion molecule E-selectin, is currently
being testing in patients with acute myeloid leukemia (AML) in a Phase
1/2 clinical study designed to evaluate its safety, pharmacokinetics
(PK) and efficacy when used together with chemotherapy.
Safety, pharmacokinetic and biomarker profiles from a recently completed
Phase 1 clinical trial of GMI-1271 in healthy volunteers will also be
presented. In addition, data demonstrating that GMI-1271 can overcome
drug resistance in animal models of multiple myeloma will be presented
in an ASH poster.
For the first time, preclinical data on GMI-1359 antitumor activity in
hematologic malignancies will be presented publicly. Specifically, data
demonstrating that GMI-1359 synergizes with chemotherapy in animal
models of Flt-3 positive AML will be presented in a poster session. GMI-1359
is a compound that targets both E-selectin and CXCR4, established
pathways for cancer cell trafficking and resistance to chemotherapy.
GlycoMimetics plans to file an investigational new drug application
(IND) with the U.S. Food & Drug Administration for GMI-1359 in 2016.
“The fact that a total of four abstracts on GMI-1271 and GMI-1359 were
accepted for the ASH meeting, and that the latest data from our work is
being presented orally for the eighth year in a row at the meeting,
underscores the potential of these drug candidates as more effective
treatments for blood cancers like multiple myeloma and acute myeloid
leukemia. In addition, the data on mobilization and enrichment of
Tscm/cm cells demonstrates exciting possible applications of GMI-1271 in
cancer immunotherapy approaches,” said John
L. Magnani, Ph.D., Vice President and Chief Scientific Officer of
Glycomimetics. “Our new clinical and preclinical data show the
scientific rationale for continuing clinical testing of GMI-1271, and
the potential advancement of GMI-1359 into clinical trials.”
Details of the abstracts, including session times and locations, include:
Oral Presentation
“Mobilization of CD8+ Central Memory T-Cells with Enhanced
Reconstitution Potential in Mice By a Combination of G-CSF and
GMI-1271-Mediated E-Selectin Blockade.” Abstract Submission #86643
(Session Name: 711. Cell Collection and Processing: Comparative Studies
and Novel Agents.) Monday, December 7, 2015, 7:15 a.m. EST, Orange
County Convention Center, Tangerine 2 (WF2).
Posters
“First in Human Phase 1 Single Dose Escalation Studies of the E-Selectin
Antagonist GMI-1271 Show a Favorable Safety, Pharmacokinetic, and
Biomarker Profile.” Abstract Submission #84143 (Session Name: 201.
Granulocytes, Monocytes and Macrophages: Poster I.) Orange County
Convention Center, Hall A, Saturday, December 5, 2015 from 5:30 p.m. -
7:30 p.m. EST.
“The Dual E-Selectin/CXCR4 Inhibitor, GMI-1359, Enhances Efficacy of
Anti-Leukemia Chemotherapy in FLT3-ITD Mutated Acute Myeloid
Leukemia.” Abstract Submission #86176 (Session Name: 616. Acute Myeloid
Leukemia: Novel Therapy, Excluding Transplantation: Poster III.) Orange
County Convention Center, Hall A, Monday, December 7, 2015 from 6:00
p.m. – 8:00 p.m. EST.
“E-Selectin Ligand Expression Increases with Progression of Myeloma and
Induces Drug Resistance in a Murine Transplant Model, Which is Overcome
by the Glycomimetic E-Selectin Antagonist, GMI-1271.” Abstract
Submission #85139 (Session Name: 652. Myeloma: Pathophysiology and
Pre-Clinical Studies, Excluding Therapy: Poster I.) Orange County
Convention Center, Hall A, Saturday, December 5, 2015 from 5:30 p.m. -
7:30 p.m. EST.
The meeting abstracts are available at ASH’s
website.
About GlycoMimetics, Inc.
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 entered into an exclusive license
agreement with Pfizer for rivipansel in October 2011. Under the license
agreement, Pfizer is responsible for the clinical development,
regulatory approval and potential commercialization of rivipansel.
GlycoMimetics’s wholly-owned drug candidate (GMI-1271) for AML and other
blood disorders is also in clinical trials. Glycomimetics are molecules
that mimic the structure of carbohydrates involved in important
biological processes. Using its expertise in carbohydrate chemistry and
knowledge of carbohydrate biology, GlycoMimetics is developing a
pipeline of glycomimetic drug candidates that inhibit disease-related
functions of carbohydrates, such as the roles they play in inflammation,
cancer and infection. 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. 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 quarterly report on Form 10-Q that was filed with the
U.S. Securities and Exchange Commission on August 6, 2015, and other
filings the Company 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151109005870/en/
Copyright Business Wire 2015