Galera Appoints Eugene P. Kennedy, M.D., F.A.C.S., as Chief Medical Officer
September 01 2022 - 7:00AM
Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage
biopharmaceutical company focused on developing and commercializing
a pipeline of novel, proprietary therapeutics that have the
potential to transform radiotherapy in cancer, today announced the
appointment of Eugene P. Kennedy, M.D., F.A.C.S., as Chief Medical
Officer (CMO). Dr. Kennedy is a renowned Johns Hopkins-trained
surgical oncologist and former Chief of Pancreatic and
Hepatobiliary Surgery at Thomas Jefferson University with over 15
years’ experience in clinical development and biopharma leadership.
He will succeed Jon T. Holmlund, M.D., who will retire at the end
of this year. In the interim, Dr. Kennedy and Dr. Holmlund will
work together closely to ensure a smooth and successful transition,
with particular focus on the preparation for the Company’s
submission of an NDA to the U.S. FDA for avasopasem by the end of
2022.
“We are thrilled to welcome Gene to Galera and are immeasurably
grateful to Jon for his invaluable leadership and service over the
last 10 years,” said Mel Sorensen, M.D., Galera’s President and
CEO. “We believe Gene’s extensive clinical trial development,
regulatory strategy and oncological medical experience will be
instrumental in supporting our team’s plan to finalize our NDA
submission package for avasopasem by year-end. In addition, as we
continue advancing our anti-cancer programs in the clinic, Gene’s
proven leadership managing various aspects of a biopharma business
and his oncology expertise, including in pancreatic cancer, will
help Galera build upon and execute our long-term clinical
strategy.”
“I am honored to join Galera during this pivotal time in the
Company’s history, and I look forward to working with, and gaining
insight from, Jon in the coming months,” said Eugene P. Kennedy,
M.D., F.A.C.S., Galera’s Chief Medical Officer. “I am also eager to
collaborate with the entire Galera management team to drive forward
our ongoing anti-cancer clinical trials, aim to commercialize
avasopasem and lead innovation in the field of radiotherapy
treatment for patients with cancer.”
Before joining Galera, Dr. Kennedy served as Chief Medical
Officer at Innovative Cellular Therapeutics, where he was an
integral part of developing the Phase 1 clinical protocol and
filing a first-in-human IND for a solid tumor CAR T-cell therapy.
Previously, he served as Chief Medical Officer at Lumos Pharma,
where he was responsible for clinical development strategy and
execution, as well as investor and patient outreach. Prior to
Lumos, Dr. Kennedy served as Chief Medical Officer at NewLink
Genetics, where he oversaw clinical trials across multiple product
candidates and indications. Prior to joining NewLink Genetics, he
served as Associate Professor of Surgery at Thomas Jefferson
University and held leadership positions as Chief of the Section of
Pancreatic and Hepatobiliary Surgery and Co-Director of the
Jefferson Pancreas, Biliary, and Related Cancers Center. Dr.
Kennedy also has practiced, taught, and held leadership roles at
the Johns Hopkins Hospital and Louisiana State University and has
authored over 50 peer-reviewed publications. Dr. Kennedy received a
bachelor’s degree from the University of Virginia and an M.D. from
the Medical College of Virginia.
About Galera TherapeuticsGalera Therapeutics,
Inc. is a clinical-stage biopharmaceutical company focused on
developing and commercializing a pipeline of novel, proprietary
therapeutic candidates that have the potential to transform
radiotherapy in cancer. Galera’s selective dismutase mimetic
product candidate avasopasem manganese (GC4419, also referred to as
avasopasem) is being evaluated for radiotherapy-induced toxicities.
The Company’s second product candidate, rucosopasem manganese
(GC4711, also referred to as rucosopasem), is in clinical-stage
development to augment the anti-cancer efficacy of stereotactic
body radiation therapy in patients with non-small cell lung cancer
and locally advanced pancreatic cancer. Galera is headquartered in
Malvern, PA. For more information, please
visit www.galeratx.com.
Forward-Looking Statements This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including without limitation statements regarding: the impact of
Dr. Eugene Kennedy’s experience in supporting the Company’s plan to
finalize its NDA submission package for avasopasem by year-end; the
expectations surrounding the continued advancement of Galera’s
product pipeline; the potential safety and efficacy of Galera’s
product candidates and their regulatory and clinical development;
the timing of the submission of an NDA for avasopasem for the
treatment of radiotherapy-induced SOM in patients with locally
advanced head and neck cancer with the FDA; and the Company’s
ability to achieve its goal of transforming radiotherapy in cancer
treatment with its selective dismutase mimetics. These
forward-looking statements are based on management’s current
expectations. These statements are neither promises nor guarantees,
but involve known and unknown risks, uncertainties and other
important factors that may cause Galera’s actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: Galera’s limited operating history; anticipating
continued losses for the foreseeable future; needing substantial
funding and the ability to raise capital; Galera’s dependence on
avasopasem manganese (GC4419); uncertainties inherent in the
conduct of clinical trials; difficulties or delays enrolling
patients in clinical trials; the FDA’s acceptance of data from
clinical trials outside the United States; undesirable side effects
from Galera’s product candidates; risks relating to the regulatory
approval process; failure to capitalize on more profitable product
candidates or indications; ability to receive or maintain
Breakthrough Therapy Designation or Fast Track Designation for
product candidates; failure to obtain regulatory approval of
product candidates in the United States or other jurisdictions;
ongoing regulatory obligations and continued regulatory review;
risks related to commercialization; risks related to competition;
ability to retain key employees and manage growth; risks related to
intellectual property; inability to maintain collaborations or the
failure of these collaborations; Galera’s reliance on third
parties; the possibility of system failures or security breaches;
liability related to the privacy of health information obtained
from clinical trials and product liability lawsuits; unfavorable
pricing regulations, third-party reimbursement practices or
healthcare reform initiatives; environmental, health and safety
laws and regulations; the impact of the COVID-19 pandemic on
Galera’s business and operations, including preclinical studies and
clinical trials, and general economic conditions; risks related to
ownership of Galera’s common stock; the possibility of Galera’s
common stock being delisted from The Nasdaq Global Market; and
significant costs as a result of operating as a public company.
These and other important factors discussed under the caption “Risk
Factors” in Galera’s Annual Report on Form 10-K for the year ended
December 31, 2021 filed with the U.S. Securities and Exchange
Commission (SEC) and Galera’s other filings with the SEC could
cause actual results to differ materially from those indicated by
the forward-looking statements made in this press release. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Galera as of the
date of this release, and Galera assumes no obligation to, and does
not intend to, update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Investor Contacts:Christopher DegnanGalera
Therapeutics, Inc.610-725-1500cdegnan@galeratx.com
William WindhamSolebury Strategic
Communications646-378-2946wwindham@soleburystrat.com
Media Contact:Zara LockshinSolebury Strategic
Communications330-417-6250zlockshin@soleburystrat.com
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