First clinical trial initiated to evaluate mobilization and
enrichment of T memory stem and T central memory cells by GMI-1271
GlycoMimetics,
Inc. (NASDAQ: GLYC) announced today that preclinical data on its
novel E-selectin antagonist drug candidate GMI-1271, shared via an oral
presentation at the 57th American Society of Hematology (ASH)
annual meeting, showed the compound could be used in combination with
G-CSF (filgrastim) to mobilize and enrich progenitor T cells known as T
memory stem (Tscm) and T central memory (Tcm) cells, which provide
improved reconstitution and persistence. The company also announced that
the first healthy participant has been treated with an intravenous (IV)
formulation of GMI-1271 in a Phase 1, multiple-dose clinical study to
evaluate the investigational drug’s ability to mobilize and enrich Tscm
or Tcm cells. In addition, the trial will evaluate safety and
tolerability of the drug, alone and in combination with filgrastim, a
treatment for neutropenia that is approved by the U.S. Food and Drug
Administration (FDA).
“We have shown via our oral presentation at ASH 2015, as well as in
previous studies, that GMI-1271 has an attractive preclinical profile
and, importantly, demonstrates in animal models the capacity to mobilize
and enrich Tscm/cm cells, which are believed to be ideal for use in
adoptive T cell therapy,” said John
Magnani, Ph.D., Vice President of Research and Chief Scientific
Officer, GlycoMimetics. “Our studies point to GMI-1271 in combination
with other therapies as an effective method for enriching this key
population of T cells. We believe that this product candidate could open
the door to new immunotherapies for cancer.”
GMI-1271 is a novel and proprietary compound that is an antagonist to
E-selectin, used in combination with chemotherapy in patients with acute
myeloid leukemia (AML). Earlier this year, the FDA granted Orphan Drug
status to GMI-1271 for the treatment of AML.
The Phase 1 study will recruit approximately 42 healthy participants at
one center in the United States. The participants will receive multiple
doses of IV GMI-1271 alone, or with multiple subcutaneous (SC) doses of
filgrastim, and will be evaluated for white blood cell counts, including
subsets of CD8+ T cells. In this Phase 1 study, researchers want to
understand the potential effects of GMI-1271 as adjunctive treatment to
filgrastim. The company anticipates reporting top line data in the
second quarter of 2016.
The abstract for the oral presentation from ASH 2015 (Abstract #512),
entitled “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,” is available at ASH’s
website.
About GMI-1271
GMI-1271 is an antagonist of E-selectin, a molecule that normally aids
in adhesion of white blood cells to endothelial cells during
inflammation responses, but also can be used by cancer cells to invade
the immune cell system. GMI-1271 is being evaluated as adjunctive
treatment to standard cytotoxic chemotherapy in patients with
hematologic malignancies, particularly in AML, in elderly patients with de
novo AML, and in multiple myeloma. GlycoMimetics is conducting
this Phase 1 trial in addition to an ongoing Phase 1/2 trial designed to
evaluate the safety, pharmacokinetics (PK) and efficacy of GMI-1271,
which began in May. The Phase 1/2 trial is an open-label multicenter
study designed to determine safety, PK and efficacy of the compound in
combination with chemotherapy among male and female patients with AML.
Last year, GMI-1271 successfully completed a Phase 1 study among healthy
volunteers.
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, which
is currently being evaluated in a Phase 3 study for treatment of
vaso-occlusive crisis of sickle cell disease.
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 the GMI-1271 and the presentation of 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 on March 16,
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.
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