Aeglea BioTherapeutics Announces Clinical Collaboration with Merck to Evaluate the Combination of Aeglea’s AEB1102 (pegzila...
October 16 2017 - 8:00AM
Aeglea BioTherapeutics, Inc., (NASDAQ:AGLE) a biotechnology company
committed to developing enzyme-based therapeutics in the field of
amino acid metabolism to treat rare genetic diseases and cancer,
today announced it has entered into a clinical collaboration
agreement with Merck (known as MSD outside the United States and
Canada) to evaluate the combination of Aeglea’s AEB1102
(pegzilarginase) with Merck’s anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab), for the treatment of patients with small cell lung
cancer (SCLC).
“Earlier this year, we selected SCLC as one of the single agent
expansion arms for our ongoing Phase 1 clinical trial based on
preclinical and biomarker data indicating that SCLC may be
responsive to arginine depletion with pegzilarginase. In
addition, our preclinical data demonstrated a synergistic effect of
pegzilarginase in combination with checkpoint inhibitors,” said
James Wooldridge, M.D., chief medical officer of Aeglea. “Given the
emerging relevance of checkpoint inhibitors, such as KEYTRUDA in
SCLC, this collaboration represents an exciting step forward for
Aeglea as we investigate the potential of pegzilarginase to treat
this devastating disease.”
The multicenter Phase 1/2 study will evaluate overall response
rate in patients with extensive disease SCLC who have relapsed or
progressed after receiving platinum-based chemotherapy. Enrollment
is expected to begin in the first quarter of 2018. Additional
details of the collaboration were not disclosed.
The collaboration agreement is between Aeglea BioTherapeutics
and Merck, through a subsidiary.
About AEB1102 in Cancer
AEB1102 (pegzilarginase) is an engineered human arginase 1
enzyme designed to degrade the amino acid arginine. Aeglea is
developing pegzilarginase to treat cancers which have demonstrated
a metabolic dependency on arginine. Dysregulation of amino acid
metabolism has been shown to be a key event in tumor growth and
development. Unlike healthy cells, these tumors cells have an
abnormally high appetite for certain amino acids and are unable to
create their own supply, making them vulnerable to starvation
through depletion of that amino acid in the blood. Pegzilarginase
is intended to address an unmet need for the treatment of these
tumor types by degrading arginine in the blood, reducing its level
below the normal range to starve the tumor. Aeglea is currently
conducting two Phase 1 trials in cancer patients with advanced
solid tumors and the hematological malignancies acute myeloid
leukemia/myelodysplastic syndrome to evaluate safety and
tolerability. Data from these trials have demonstrated that
pegzilarginase reduces blood arginine levels, providing initial
human proof of mechanism. The company plans to initiate expansion
arms of the advanced solid tumor trial in cutaneous melanoma, uveal
melanoma and small cell lung cancer in the fourth quarter of 2017
or the first quarter of 2018.
About Aeglea BioTherapeutics
Aeglea is a biotechnology company committed to developing
enzyme-based therapeutics in the field of amino acid metabolism to
treat rare genetic diseases and cancer. The company’s engineered
human enzymes are designed to modulate the extremes of amino acid
metabolism in the blood to reduce toxic levels of amino acids in
inborn errors of metabolism or target tumor metabolism for cancer
treatment. AEB1102, Aeglea’s lead product candidate, is currently
being studied in two ongoing Phase 1 clinical trials, in patients
with advanced solid tumors and acute myeloid
leukemia/myelodysplastic syndrome (AML/MDS). Additionally, Aeglea
is recruiting patients into its ongoing Phase 1/2 trial of AEB1102
for the treatment of patients with Arginase 1 Deficiency. The
company is building a pipeline of additional product candidates
targeting key amino acids.
For more information, please
visit http://aegleabio.com.
Safe Harbor / Forward Looking Statements
This press release contains "forward-looking" statements within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: "anticipate,"
"intend," "plan," "goal," "seek," "believe," "project," "estimate,"
"expect," "strategy," "future," "likely," "may," "should," "will"
and similar references to future periods. These statements are
subject to numerous risks and uncertainties that could cause actual
results to differ materially from what we expect. Examples of
forward-looking statements include, among others, statements we
make regarding our future partnership opportunities, the timing and
success of our clinical collaboration with Merck, and the potential
therapeutic benefits and economic value of our lead product
candidate or other product candidates. Further information on
potential risk factors that could affect our business and its
financial results are detailed in our most recent Quarterly Report
on Form 10-Q for the quarter ended June 30, 2017 filed
with the Securities and Exchange Commission (SEC), and
other reports as filed with the SEC. We undertake no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA
Media Contact:Kelly Boothe, Ph.D.Pure
Communications415.946.1076media@aegleabio.com
Investor Contact:Charles N. York IIChief
Financial OfficerAeglea BioTherapeuticsinvestors@aegleabio.com
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