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
interim data from the full patient population (n=42) in its Phase
1/2 clinical trial of avasopasem manganese (GC4419) in combination
with stereotactic body radiation therapy (SBRT) in patients with
locally advanced pancreatic cancer (LAPC). The data were presented
today during the late-breaker special session of the 2020 American
Society for Radiation Oncology (ASTRO) virtual Annual Meeting.
GC4419 is an investigational, highly selective small molecule
superoxide dismutase mimetic designed to rapidly and selectively
convert superoxide to hydrogen peroxide and oxygen. The randomized,
double-blind, multicenter, placebo-controlled pilot dose escalation
Phase 1/2 trial was designed to evaluate the safety and efficacy of
GC4419 in combination with SBRT, compared with SBRT and placebo, in
patients with LAPC. The trial assessed safety and efficacy of SBRT
when combined with GC4419 or placebo. After completion of induction
chemotherapy, patients were randomized (1:1) to receive
five-fraction SBRT and 90 mg of GC4419 or placebo control by
intravenous infusion one hour prior to each SBRT fraction.
In the interim analysis of the intent-to-treat population
(n=42), median overall survival (OS) had not been reached at the
data cutoff (date of August 24, 2020) in the GC4419 arm, compared
to 38.7 weeks (HR=0.4; 95% CI: 0.12-1.11; p=0.06) in the placebo
arm. Six-to-eight weeks post-SBRT, patients underwent
protocol-specified evaluation for resection, and seven underwent
resection. Of the patients in the GC4419 arm who were surgically
resected (n=5), all achieved clear / negative margins (R0), one
achieved pathological complete response (pCR) and four achieved
pathological partial response (pPR), compared to one R0 and pPR of
the two surgically resected patients in the placebo arm. No
statistically significant differences in progression-free survival
(PFS) were observed between GC4419 and placebo (HR=0.6; 95% CI:
0.23-1.56; p=0.29). However, patients were censored for PFS at the
date of surgical resection or due to short interval follow up.
Toxicity was comparable across both treatment arms, with no
significant differences in acute (<90 days) or late (91-365
days) Grade 3+ toxicity post-SBRT.
“The survival rate in pancreatic cancer is dismal. Our goals for
treatment are to extend survival and improve the potential for
surgical resection, as surgery remains the only potentially
curative therapy for pancreatic cancer,” said Sarah Hoffe, M.D.,
Section Head of GI Radiation Oncology and Senior Member at Moffitt
Cancer Center, trial first author and investigator. “These interim
data signal the potential of dismutase mimetics, when combined with
SBRT, to prolong survival in patients with LAPC. Further study of
dismutase mimetics to expand the utility of SBRT in pancreatic
cancer treatment is warranted.”
The interim data includes all patients followed for a minimum of
three months and 19 for more than one year, with data through
August 24, 2020. The Company plans to provide an additional update
on this trial with at least one year of follow up on all patients
in the second half of 2021.
“We’re encouraged by the favorable overall survival benefit in
this difficult-to-treat cancer observed in the interim data in this
trial, which is the first trial evaluating the anti-cancer activity
of one of Galera’s dismutase mimetics in combination with SBRT,”
said Mel Sorensen, M.D., President and CEO of Galera. “Galera’s
dismutase mimetics are designed to improve radiation therapy by
both increasing therapeutic anti-tumor efficacy at higher doses of
radiation and by protecting normal cells, and we look forward to
advancing the development of this potential combination therapy and
expanding into other cancers to improve outcomes for patients
undergoing radiotherapy for the treatment of cancer.”
The Company plans to leverage observations from this pilot trial
to further develop GC4711, its second superoxide dismutase mimetic
clinical candidate, specifically for use in combination with SBRT,
and anticipates initiating a follow-on Phase 2 trial in pancreatic
cancer with GC4711 in combination with SBRT in the first half of
2021. Galera recently announced it is also evaluating the
anti-cancer activity of GC4711 in an ongoing Phase 1/2 trial in
combination with SBRT in patients with non-small cell lung cancer
(NSCLC).
The presentation is available for on-demand viewing for
registered ASTRO attendees for the next 30 days.
Conference Call
Galera will host a live audio webcast at 4:30 p.m. EDT
today accessible from the Investors page of Galera’s website,
investors.galeratx.com. An archived version of the webcast will be
available in the News & Events section of the Investors page of
Galera’s website for 60 days following the event.
About GC4419 (Avasopasem Manganese)
Galera’s lead product candidate, avasopasem manganese, is an
investigational, highly selective small molecule superoxide
dismutase (SOD) mimetic that is initially being developed for the
reduction of radiation-induced severe oral mucositis (SOM), which
is not yet approved. Avasopasem is designed to rapidly and
selectively convert superoxide to hydrogen peroxide and oxygen,
protecting normal tissue from damage associated with radiation
therapy. Left untreated, elevated superoxide can damage
noncancerous tissues and lead to debilitating side effects,
including oral mucositis (OM), which can limit the anti-tumor
efficacy of radiation therapy.
Avasopasem is currently being studied in the ROMAN trial, a
randomized, double-blind, placebo-controlled Phase 3 trial of
approximately 450 patients (NCT03689712, available
at clinicaltrials.gov) to investigate
the effects of avasopasem on radiation-induced OM in patients with
locally advanced head and neck cancer. In Galera’s 223-patient,
double-blind, randomized, placebo-controlled Phase 2b trial in
patients with locally advanced head and neck cancer receiving
concurrent radiation therapy, avasopasem produced a statistically
significant reduction in duration of SOM from 19 days to 1.5 days
(92 percent) in the 90 mg treatment arm. Avasopasem also
demonstrated clinically meaningful reductions in SOM incidence
through completion of radiation by 34 percent and in the severity
of OM (incidence of Grade 4 OM) by 47 percent in the 90 mg
treatment arm. The overall safety findings for avasopasem in the
Phase 2b trial was similar to that of placebo and consistent with
the known adverse effects of chemoradiation, with reductions of
blood cell counts, particularly low lymphocyte counts, the most
prominent adverse events. Adverse events considered attributable to
avasopasem were limited to mild, transient postural
light-headedness or decreased blood pressure. Patients were
followed for two years after enrollment and showed no difference in
tumor outcomes between active and control, consistent with
expectations for combinations with intensity-modulated radiation
therapy (IMRT)/cisplatin, suggesting that the efficacy of the
chemoradiation therapy was not compromised.
Avasopasem is also currently being studied in a Phase 2a trial
for its potential to reduce the incidence of radiation-induced
esophagitis in patients with lung cancer (NCT04225026, available
at clinicaltrials.gov) and in a Phase 2 trial
in hospitalized patients who are critically ill with COVID-19
(NCT04555096, available
at clinicaltrials.gov); and a pilot Phase 1/2
trial (NCT03340974, available
at clinicaltrials.gov) of avasopasem in
combination with stereotactic body radiation therapy (SBRT) in
patients with locally advanced pancreatic cancer was completed.
The U.S. Food and Drug Administration granted Fast
Track and Breakthrough Therapy designations to avasopasem for the
reduction of SOM induced by radiotherapy.
About Galera Therapeutics
Galera Therapeutics, Inc. is 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. Galera’s lead product candidate
is avasopasem manganese (GC4419), a highly selective small molecule
superoxide dismutase (SOD) 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 a Phase 2a
multi-center trial in Europe assessing the safety of avasopasem in
patients with HNC undergoing standard-of-care radiotherapy, a 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 was completed. The FDA granted
Fast Track and Breakthrough Therapy designations to avasopasem for
the reduction of SOM induced by radiotherapy. Galera’s second SOD
mimetic product candidate, GC4711, is initially being developed to
augment the anti-cancer efficacy of radiation and is currently
being studied in a Phase 1/2 clinical trial in combination with
SBRT in patients with non-small cell lung 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 potential, safety, efficacy, and regulatory and
clinical development of Galera’s product candidates, including with
respect to the pilot Phase 1/2 clinical trial of GC4419 in
combination with SBRT for LAPC and related data readouts, as well
as the development of GC4711; and Galera’s participation in
upcoming events and presentations. 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;
results of earlier studies and trials may not be predictive of
future trial results; interim, topline and preliminary data may
change as more patient data become available, and are subject to
audit and verification procedures that could result in material
changes in the final data; 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 for
which we have not yet received such designations; 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 Quarterly Report on Form 10-Q
for the quarterly period ended June 30, 2020 filed with the U.S.
Securities and Exchange Commission (SEC), Annual Report on Form
10-K for the year ended December 31, 2019 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
Jennifer PorcelliSolebury
Trout646-378-2962jporcelli@soleburytrout.com
Media Contact:Heather Anderson6
Degrees919-827-5539handerson@6degreespr.com
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