Apollomics, Inc Doses First Patient in Phase 1 Clinical Trial in China of GlycoMimetics’ Uproleselan for the Treatment of A...
March 04 2021 - 8:30AM
Business Wire
GlycoMimetics (Nasdaq: GLYC) today announced that Apollomics has
dosed the first patient in China in a Phase 1 clinical trial of
APL-106 (uproleselan injection) for the treatment of adults with
relapsed or refractory acute myeloid leukemia (AML). In February of
this year, Apollomics initiated two Phase 1 study sites in Greater
China.
“Dosing of the first patient in Greater China is a significant
accomplishment for Apollomics. Equally important is the fact that
Apollomics support for uproleselan reflects a broad level of
interest in our drug candidate’s potential to make a real
difference for AML patients. Clearly, for patients with
relapsed/refractory disease, there is a huge unmet need,” noted
Rachel King, GlycoMimetics Chief Executive Officer. “We believe
that Apollomics’ track record and leadership are particularly
qualified to take this program through clinical development and on
to commercialization.”
The Phase 1 clinical trial in China is a part of the Phase 1 and
Phase 3 bridging clinical study of APL-106 in combination with
chemotherapy in adults with relapsed or refractory AML. Its
principal investigator is Professor Jianxiang Wang of the Institute
of Hematology and Blood Diseases Hospital, Chinese Academy of
Medical Sciences and Peking Union Medical College. The primary
objective of the Phase 1 trial is to study the pharmacokinetic (PK)
characteristics of APL-106 in Chinese subjects with relapsed or
refractory AML and to evaluate the safety and tolerability of
APL-106 in combination with chemotherapy.
About Uproleselan
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 the treatment of adult AML
patients with relapsed or refractory disease. In January 2021, it
was also granted Breakthrough Therapy Designation by the Center for
Drug Evaluation (CDE) of the NMPA in China. 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 Apollomics, Inc.
Apollomics, Inc. is an innovative biopharmaceutical company
committed to the discovery and development of mono- and
combination- oncology therapies to harness the immune system and
target specific molecular pathways to eradicate cancer. The
company’s existing pipeline consists of several development-stage
assets including novel, humanized monoclonal antibodies that
restore the body’s immune system to recognize and kill cancer
cells, and targeted therapies against uncontrolled growth signaling
pathways. For more information, please visit
www.apollomicsinc.com.
About GlycoMimetics, Inc.
GlycoMimetics is a biotechnology company with a focus in
hematology-oncology 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 in
a Company-sponsored Phase 3 trial in relapsed/refractory AML.
GlycoMimetics has an ongoing Phase 1b clinical trial evaluating
GMI-1359, a combined CXCR4 and E-selectin antagonist, also a
wholly-owned drug candidate,. 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 and potential benefit and impact of
the Company’s product candidate, uproleselan. 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 March 2, 2021, 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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version on businesswire.com: https://www.businesswire.com/news/home/20210304005541/en/
Investor: Shari Annes Phone: 650-888-0902 Email:
sannes@annesassociates.com Media: Jamie Lacey-Moreira Phone:
410-299-3310 Email: jamielacey@presscommpr.com
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