Science Translational Medicine Article Shows Galera’s Selective Dismutase Mimetic Synergizes with Radiotherapy to Ablate Tu...
May 12 2021 - 4:01PM
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 that
Science Translational Medicine has published a foundational
preclinical article describing the synergy of avasopasem manganese,
one of the Company’s selective dismutase mimetics, with high
fraction dose radiotherapy, such as stereotactic body radiation
therapy (SBRT) or stereotactic ablative radiotherapy (SAbR), in
killing tumors. The research, a collaboration between scientists at
University of Texas Southwestern, University of Iowa and Galera, is
part of the basis for two ongoing clinical trials with the
Company’s dismutase mimetics in combination with SBRT in pancreatic
cancer and lung cancer. Galera recently reported clinical results
from its placebo-controlled Phase 1/2 pilot trial, showing that the
combination of its selective dismutase mimetic with SBRT nearly
doubled the median overall survival of patients with locally
advanced pancreatic cancer (LAPC).
“We are gratified to have these results published
in Science Translational Medicine describing the strong scientific
rationale which underpin the promising clinical data seen in our
pancreatic cancer trial,” said Mel Sorensen, M.D., President and
CEO of Galera. “We thank our research collaborators who have helped
us lay out the novel scientific basis for this potentially
groundbreaking therapy for patients.”
The publication, “Avasopasem manganese synergizes
with hypofractionated radiation to ablate tumors through the
generation of hydrogen peroxide,” reports from preclinical cell and
tumor models that the selective dismutase mimetic — by converting
superoxide produced as a byproduct of radiotherapy into hydrogen
peroxide — increased cancer cell killing with radiation. The
synergy between the mimetic and radiotherapy increased with larger
daily doses (“fractions”) of radiation. Moreover, in the range of
fraction sizes typical of SBRT, the combination ablated many of the
tumors. In addition, as previously published, the authors report
that by removing the superoxide, the dismutase mimetics protected
normal cells from radiation toxicity. These two separate benefits
of the dismutase mimetics with radiotherapy act through the
differential responses to superoxide and hydrogen peroxide by
normal cells and cancer cells and are at the core of Galera’s
clinical programs.
Consistent with today’s publication, Galera
recently reported updated clinical results from a randomized,
placebo-controlled Phase 1/2 pilot trial in which a near doubling
of median overall survival was observed in patients with LAPC
treated with a dismutase mimetic combined with SBRT versus placebo
plus SBRT. Final results from this trial are expected in the second
half of 2021. Building on the pilot trial, the Company expects to
open the randomized Phase 2b GRECO-2 trial of GC4711, its second
dismutase mimetic product candidate, in combination with SBRT in
patients with LAPC in the first half of this year. Galera’s Phase
1/2 GRECO-1 trial of GC4711 is ongoing, testing its dismutase
mimetic in combination with SBRT for patients with non-small cell
lung cancer.
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 avasopasem 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, with or without
systemic therapy. 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. Galera also intends to initiate the
GRECO-2 Phase 2b trial of GC4711 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 plans and timing for the commencement of
and the release of data from Galera’s clinical trials. 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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