Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of hematology
and oncology therapeutics that address unmet medical needs, today
announced data from the Company’s GALE-301 Phase 1/2a clinical
trial was presented at the CRI-CIMT-EATI-AACR International Cancer
Immunotherapy Conference in New York, NY. The focus of the
presentation was on the association between clinical outcomes and
folate binding protein (FBP) expression. GALE-301 is administered
with the adjuvant granulocyte macrophage-colony stimulating factor
(GM-CSF) for the prevention of cancer recurrence in disease-free
ovarian and endometrial cancer patients.
Poster #B007, entitled, “Improved disease-free survival in
endometrial and ovarian cancer patients with low folate binding
protein expression after treatment with the E39 peptide vaccine in
a phase I/IIa trial,” reported clinical outcomes based on FBP
expression level. The data revealed a disease free survival (DFS)
benefit in patients with low FBP expression (FBPlo), but not in
patients with high FBP expression (FBPhi).
“The results presented today are quite informative to our
program as little is known about the effects of FBP expression
levels on FBP-directed therapies, including the GALE-301 (E39)
vaccine,” said Bijan Nejadnik, M.D., Executive Vice President and
Chief Medical Officer. “The fact that the low expressors
appeared to show a better DFS benefit may be due to immunotolerance
from significantly higher endogenous exposure to the FBP
antigen. This is also something we explored with our
GALE-302, or attenuated version, of the peptide. These findings
warrant further study as they may help inform the design and target
patient populations for the next clinical trial for our folate
binding protein development programs.”
Thirty-eight enrolled patients underwent FBP expression testing,
and there were no clinicopathologic differences between the vaccine
group (VG n=18) and the control group (CG n=20) or within FBPhi (VG
n=10; CG n=9) and FBPlo (VG n=8; CG n=11;) (p≥0.1). There were
significantly more primary tumors in FBPlo vs. FBPhi (p=0.027) and
median follow up for the study was 16.3 months. While there was no
significant difference in overall DFS between the CG and the VG
(34.6% vs. 34.6%, p=0.208), in FBPlo patients, there was improved
DFS in the VG at 85.7% vs. the CG at 17.5% (p=0.01). There
was no such difference in FBPhi patients (VG 13.9% vs. CG 44.4%,
p=0.83). Though groups were small, there was a dose-dependent
effect in the FBPlo patients receiving 1000mcg (n=4) having
improved DFS compared to the <1000mcg patients (n=4) and the CG
(n=3) (100% vs. 66.7% vs.17.5%, respectively, p=0.03). Comparing
FBPlo and FBPhi patients in the VG, the FBPlo patients had improved
DFS (85.7% vs. 13.9%, p=0.052). In the CG, FBPlo patients did worse
(17.5% vs. 44.4% in FBPhi, p=0.371).
Disease-free, HLA-A2-positve patients were vaccinated, while
HLA-A2-negative patients were followed as untreated controls. The
vaccine group received six monthly inoculations of GALE-301+GM-CSF,
including either 100, 500, or 1000 mcg of peptide and 250mcg of
GM-CSF. FBP expression testing was performed by
immunohistochemistry and the results were graded 0-4+ based on the
percentage of positively staining cells. Patient’s tumors were then
categorized as FBPlo if scored 0-1+ or FBPhi if 2-4+. The patients
were monitored for evidence of clinical recurrence through the
standard of care follow-up by their treating oncology team.
Demographics, FBP expression, and DFS were analyzed using
appropriate statistical tests.
The poster presentation from the conference will be available on
Galena’s website here.
About GALE-301
GALE-301 is a cancer immunotherapy that consists of a peptide
derived from Folate Binding Protein (FBP) combined with the immune
adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF)
for the prevention of cancer recurrence in the adjuvant
setting. FBP is a well-validated therapeutic target that is
highly over-expressed in ovarian, endometrial and breast cancers.
FBP is the source of immunogenic peptides that can stimulate
cytotoxic T lymphocytes (CTLs) to recognize and destroy
FBP-expressing cancer cells. Enrollment has been completed in the
GALE-301 Phase 2a portion of the Phase 1/2a clinical trial in two
gynecological cancers: ovarian and endometrial adenocarcinomas
(ClinicalTrials.gov Identifier: NCT01580696).
About Ovarian/Endometrial Cancers
New cases of ovarian cancer occur at an annual rate of 11.9 per
100,000 women in the U.S., with an estimated 22,280 new cases and
14,240 deaths in 2016. Approximately 46.2% of ovarian cancer
patients are expected to survive five years after diagnosis.
Approximately 1.3% of women will be diagnosed with ovarian cancer
at some point during their lifetime (2011 – 2013 data). The
prevalence data from 2013 showed an estimated 195,767 women living
with ovarian cancer in the United States.
Due to the lack of specific symptoms, the majority of ovarian
cancer patients are diagnosed at later stages of the disease, with
an estimated 75% of women presenting with advanced-stage (III or
IV) disease. These patients have their tumors routinely surgically
debulked to minimal residual disease, and then are treated with
platinum- and/or taxane-based chemotherapy. While many patients
respond to this treatment regimen and become clinically
free-of-disease, the majority of these patients will relapse.
Depending upon their level of residual disease, the risk for
recurrence after completion of primary therapy ranges from 60% to
85%. Unfortunately for these women, once the disease recurs,
treatment options are limited and the disease remains
incurable.
New cases of endometrial cancer occur at an annual rate of 25.4
per 100,000 women in the U.S., with an estimated 60,050 new cases
and 10,470 deaths in 2016. Approximately 81.7% of endometrial
cancer patients are expected to survive five years after diagnosis.
Approximately 2.8% of women will be diagnosed with ovarian cancer
at some point during their lifetime (2010 – 2013 data). The
prevalence data from 2013 showed an estimated 635,437 women living
with endometrial cancer in the United States.
Source: National Cancer Institute Surveillance, Epidemiology,
and End Results Program
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company committed
to the development and commercialization of hematology and oncology
therapeutics that address unmet medical needs. Galena’s pipeline
consists of multiple mid-to-late-stage clinical assets led by its
hematology asset, GALE-401, and novel cancer immunotherapy programs
including NeuVax™ (nelipepimut-S) and GALE-301/GALE-302. For more
information, visit www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to,
statements about the progress of the development of Galena’s
product candidates, including GALE-301, patient enrollment in our
clinical trials, as well as other statements related to the
progress and timing of our development activities, present or
future licensing, collaborative or financing arrangements, expected
outcomes with regulatory agencies, and projected market
opportunities for product candidates or that otherwise relate to
future periods. These forward-looking statements are subject to a
number of risks, uncertainties and assumptions, including those
identified under “Risk Factors” in Galena’s Annual Report on Form
10-K for the year ended December 31, 2015 and most recent Quarterly
Reports on Form 10-Q filed with the SEC. Actual results may differ
materially from those contemplated by these forward-looking
statements. Galena does not undertake to update any of these
forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this press
release.
NeuVax is a trademark of Galena Biopharma, Inc.
Contact:
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
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