Galera Announces First Patient Dosed with GC4711 in Phase 2b GRECO-2 Trial in Patients with Pancreatic Cancer
May 17 2021 - 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
first patient has been dosed in the randomized Phase 2b GRECO-2
trial of GC4711 in combination with stereotactic body radiation
therapy (SBRT) in patients with locally advanced pancreatic cancer
(LAPC). GC4711 is a selective small molecule dismutase mimetic
being developed to increase the anti-cancer effect of radiation.
Enrollment of the first patient in this trial has triggered a $20
million milestone payment from funds managed by Blackstone Life
Sciences to Galera under the amended royalty agreement.
“We are excited to start this large Phase 2b trial in pancreatic
cancer following the promising data from our initial trial in these
patients, a placebo-controlled Phase 1/2 pilot trial, in which we
saw a near doubling of overall survival in patients receiving a
dismutase mimetic with SBRT,” said Mel Sorensen, M.D., President
and CEO of Galera. “In addition, the $20 million milestone payment
from Blackstone ensures we are well capitalized to advance this
trial in addition to our programs in lung cancer and
radiation-induced severe oral mucositis as we prepare for the
potential regulatory approval and commercialization of avasopasem,
our lead dismutase mimetic product candidate.”
GRECO-2 is a randomized, double-blind, placebo-controlled Phase
2b trial evaluating the effect of 100 mg of GC4711 or placebo in
combination with SBRT on overall survival (OS), the trial’s primary
endpoint, in patients with LAPC. Secondary endpoints include
progression-free survival (PFS), locoregional control (LRC), time
to distant metastases (TDM) and surgical resection, in addition to
safety. The trial is expected to enroll approximately 160
patients.
“In the fight against pancreatic cancer, which has a 10%
five-year survival rate and few treatment options, clinical trials
are critical,” said Julie Fleshman, J.D., MBA, President and CEO of
the Pancreatic Cancer Action Network (PanCAN). “Galera’s GRECO-2
study, as well as the other studies in our comprehensive database
of pancreatic cancer clinical trials available in the U.S.,
investigates cutting edge research and has the potential to improve
patient outcomes.”
Additional information on GRECO-2 can be found
on clinicaltrials.gov using the
identifier NCT04698915.
About GC4711
Galera’s selective dismutase mimetic product candidates, GC4711
and GC4419, are small molecules being developed to protect normal
cells and sensitize cancer cells to radiotherapy. GC4711 is in
development specifically to augment the anti-cancer efficacy of
stereotactic body radiation therapy (SBRT). The molecule is
currently being studied in a Phase 1/2 trial in combination with
SBRT in patients with non-small cell lung cancer (NCT04476797) and
a Phase 2b trial in combination with SBRT in patients with locally
advanced pancreatic cancer (NCT04698915).
About Galera Therapeutics
Galera 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 lead product
candidate is avasopasem manganese (GC4419, also referred to as
avasopasem), a selective small molecule dismutase mimetic initially
being developed for the reduction of radiation-induced severe oral
mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN
trial to assess its ability to reduce the incidence and severity of
SOM induced by radiotherapy in patients with locally advanced head
and neck cancer (HNC), its lead indication. It is also being
studied in the EUSOM Phase 2a multi-center trial in Europe
assessing the safety of avasopasem in patients with HNC undergoing
standard-of-care radiotherapy, the AESOP Phase 2a trial to assess
its ability to reduce the incidence of esophagitis induced by
radiotherapy in patients with lung cancer, and a Phase 2 trial in
hospitalized patients who are critically ill with COVID-19. A pilot
Phase 1/2 trial of GC4419 in combination with stereotactic body
radiation therapy (SBRT) in patients with locally advanced
pancreatic cancer (LAPC) has completed enrollment and reported
updated results, with follow-up ongoing. The FDA granted Fast Track
and Breakthrough Therapy designations to avasopasem for the
reduction of SOM induced by radiotherapy. Galera’s second dismutase
mimetic product candidate, GC4711, is being developed specifically
to augment the anti-cancer efficacy of SBRT, and is currently being
studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in
patients with non-small cell lung cancer and the GRECO-2 Phase 2b
trial in combination with SBRT in patients with LAPC. 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: expectations surrounding our growth and the continued
advancement of our product pipeline, including plans for the
commercial launch of avasopasem; the potential, safety, efficacy,
and regulatory and clinical development of Galera’s product
candidates; and expected payments from Blackstone. 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 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; 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, 2020 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
Trout646-378-2946wwindham@soleburytrout.com
Media Contact:Zara LockshinSolebury
Trout646-378-2960zlockshin@soleburytrout.com
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