AUSTIN,
Texas, Nov. 30, 2022 /PRNewswire/ -- Aeglea
BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology
company developing a new generation of human enzyme therapeutics as
innovative solutions for rare metabolic diseases, today announced
the appointment of Jeffrey M.
Goldberg as president, chief executive officer and member of
the board of directors effective November
29, 2022. Mr. Goldberg is an accomplished biotech executive
with over 25 years of experience leading teams from preclinical
discovery through commercialization and previously served as
president and chief executive officer of Immunitas
Therapeutics.
"Jeff has successfully built and managed teams across a wide
variety of functions, providing strong leadership and strategic
direction. His breadth of experience spans from the founding of
companies to overseeing successful global launches of rare disease
therapies," said Russell J. Cox,
chair of the board of directors of Aeglea. "His proven ability to
match business capabilities to unmet patient needs and then drive
the strategy and execution needed to achieve those goals will be an
important asset to Aeglea. I look forward to working closely with
Jeff and welcome him to the Aeglea team."
"To me, the most important and fulfilling part of my job has
been being able to bring therapies forward that have had
significant impact on patients' lives. Aeglea shares that mission
and has built world-class programs in Homocystinuria and Arginase 1
Deficiency with the potential to benefit all the key stakeholders,
including employees, shareholders, physicians, and most importantly
patients and their families," said Mr. Goldberg. "I'm incredibly
excited to be joining the team and helping to facilitate the
mission of developing novel medicines for patients battling
devastating diseases."
Mr. Goldberg served as president and chief executive officer at
Immunitas from 2019-2021. Under his leadership, Immunitas grew
significantly, raised additional capital, and is now in the clinic
with its first asset. Prior to joining Immunitas, Mr. Goldberg
served as the founding chief operating officer at Akcea where
he was responsible for building functions and leading teams across
all aspects of the business and eventually grew the team from two
employees to over 250 in multiple geographies. Mr. Goldberg played
a significant role in the company's initial public offering and
fundraising activities, business development and the global launch
of two rare disease drugs. Prior to Akcea, he was the vice
president of business operations at Proteostasis Therapeutics, a
rare disease company. He also held roles of increasing
responsibility at Genzyme, where he led teams through product
development and global launches across multiple therapeutic areas.
Mr. Goldberg has an MBA and a MS in Chemical Engineering from the
Massachusetts Institute of Technology,
and a B.S. in Chemical Engineering from Cornell University.
Jim Kastenmayer, JD, PhD, will
step down as interim chief executive officer and retain his
position as Aeglea's general counsel. "On behalf of the entire
board of directors, I want to thank Jim for his service and
commitment to Aeglea and its mission. Jim has provided exceptional
leadership during a period of critical execution and has kept the
team focused on advancing the Homocystinuria program," said Mr.
Cox.
Following the leadership transition and as part of the related
evaluation of near-term corporate and clinical development
strategy, Aeglea no longer plans to announce interim clinical data
from the ongoing Phase 1/2 clinical trial of pegtarviliase in
Classical Homocystinuria in the fourth quarter of 2022. Enrollment
in the third cohort of the Phase 1/2 trial is ongoing with two
patients having completed dosing in the cohort. Additionally, the
company has decided not to participate in the Piper Sandler
34th Annual Healthcare Conference and 5th
Annual Evercore ISI HealthCONx Conference, both being held
November 29-December 1, 2022. Aeglea
looks forward to delivering a clinical update on the pegtarviliase
program when more comprehensive data from the third cohort becomes
available.
About Classical
Homocystinuria
Classical Homocystinuria, also known as CBS deficiency, is a
serious, progressive metabolic disorder characterized by elevated
levels of total homocysteine. The accumulation of total
homocysteine leads to a wide range of life-altering complications
and even death from sudden catastrophic events. Serious disease
complications may include thromboembolic vascular events, skeletal
abnormalities (including severe osteoporosis and Marfanoid
features), developmental delay, intellectual disability, lens
dislocation and severe near sightedness. Currently, there are no
approved treatments that address the underlying driver of
disease.
About Aeglea
BioTherapeutics
Aeglea BioTherapeutics is a clinical-stage biotechnology company
redefining the potential of human enzyme therapeutics to benefit
people with rare metabolic diseases with limited treatment options.
Aeglea is investigating pegtarviliase in an ongoing Phase 1/2
clinical trial for the treatment of Classical Homocystinuria.
Pegtarviliase has been granted Rare Pediatric Disease Designation.
Aeglea's other clinical program, pegzilarginase, achieved the
primary endpoint of arginine reduction in the PEACE Phase 3
clinical trial and has received both Rare Pediatric Disease and
Breakthrough Therapy Designations. The Marketing Authorization
Application for pegzilarginase is currently under review with the
European Medicines Agency. Aeglea has an active discovery platform
focused on engineering small changes in human enzymes to have a big
impact on the lives of patients and their families. For more
information, please visit http://aeglea.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 ability to achieve further cost-savings, the
timing of announcements and updates relating to our clinical trials
and related data, including the clinical data for our Phase 1/2
trial of pegtarviliase in Classical Homocystinuria, the timing and
success of our clinical trials and related data, the timing and
expectations for regulatory submissions and approvals, including
the MAA for pegzilarginase in Europe, our ability to obtain regulatory
approval for, and commercialize, pegzilarginase, recognize
milestone and royalty payments from our agreement with Immedica,
our ability to enroll patients into our clinical trials, the
expected impact of the COVID-19 pandemic on our operations and
clinical trials, success in our collaborations, the length of time
that we believe our existing cash resources will fund operations,
the potential addressable markets of our product candidates 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 September
30, 2022 filed with the Securities and Exchange Commission
(SEC), and our 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.
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SOURCE Aeglea BioTherapeutics, Inc.