Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of targeted
oncology therapeutics that address major unmet medical needs, today
announced that data from the booster phase of the Company’s
GALE-301/GALE-302 Phase 1/2a clinical trial was presented at the
American Association for Cancer Research (AACR) Annual Meeting.
The poster, entitled, “Comparing an attenuated booster (E39’)
vs. E39 booster to potentiate the clinical benefit of the folate
binding protein (FBP)-derived vaccine (E39 + GM-CSF) in a phase
I/IIa trial to prevent recurrence in endometrial (EC) and ovarian
cancer (OC) patients,” was presented today by Dr. Doreen Jackson
from the San Antonio Military Medical Center. In the Phase 2a
portion of the trial, patients were randomized to two different
boosters: E39 (GALE-301), versus E39’ (GALE-302). The purpose of
the study was to evaluate the immune responses and determine which
booster, if either, would provide a sustained immune response and
potentially longer disease free survival (DFS) rates.
The use of the wildtype peptide (GALE-301/E39) demonstrated the
same tolerable safety profile as the attenuated peptide
(GALE-302/E39’) with only Grade 1 local reactions and minimal Grade
2 toxicities. Importantly, the percentage of patients who
received two booster inoculations and remained disease free was
significantly better in the drug treatment arm, versus the control
arm (p=0.02), regardless of which booster was used. At median
follow up of 16 months, the boosters demonstrated equivalent
efficacy after two booster inoculations with an estimated, two-year
DFS rate of 66.7% (GALE-301 n=7, GALE-302 n=7) in each booster arm
versus 36% (n=22) in the control arm.
“In our GALE-301 Phase 2a trial, we randomized patients to
determine an optimal boosting strategy and to see if there was an
observable difference between boosting patients with GALE-301
versus the attenuated version of the peptide, GALE-302,” stated
Bijan Nejadnik, M.D., Executive Vice President and Chief Medical
Officer. “The results show that both boosters were effective
with no measurable difference between them, and we will consider
this as we continue to evaluate the best path forward for our
compounds targeting FBP. The primary analysis of this trial
will be presented at the upcoming American Society of Clinical
Oncology meeting in June.”
A total of 51 patients were enrolled in the Phase 1/2a trial
with 29 HLA-A2-positive patients in the vaccine group (VG) and 22
HLA-A2-negative patients in the control group (CG). Six
monthly intradermal inoculations of GALE-301 plus 250mcg GM-CSF
were administered to the VG to complete the primary vaccine series
(PVS). Patients were then randomized to receive two booster
inoculations of 500mcg of GALE-301 or GALE-302 plus 250mcg GM-CSF
at six and twelve months post-PVS. Seventeen patients
continued onto the booster series and were randomized with 14
receiving two boosters. There were no significant demographic or
baseline differences between groups, no difference in toxicities
were observed, and there were no Grade 3 or 4 toxicities in either
group.
About GALE-301 and GALE-302
GALE-301 and GALE-302 are cancer immunotherapies that consist 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. GALE-301 is the E39 peptide, while GALE-302
is an attenuated version of this peptide, known as E39’. FBP
is a well-validated therapeutic target that is highly
over-expressed in ovarian, endometrial and breast cancers, and is
the source of immunogenic peptides that can stimulate cytotoxic T
lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer
cells. Two trials are ongoing with FBP peptides in gynecological
cancers: the GALE-301 Phase 2a portion of the Phase 1/2a clinical
trial is ongoing in ovarian and endometrial adenocarcinomas
(ClinicalTrials.gov Identifier: NCT01580696); the GALE-301 plus
GALE-302 Phase 1b clinical trial is ongoing in breast and ovarian
cancers (ClinicalTrials.gov Identifier: NCT02019524).
About Ovarian/Endometrial Cancers
New cases of ovarian cancer occur at an annual rate of 12.1 per
100,000 women in the U.S., with an estimated 21,290 cases for 2015.
Although ovarian cancer represents about 1.3% of all cancers, it
represents about 2.4% of all cancer deaths, or an estimated 14,180
deaths in 2015. Approximately 1.3% of women will be diagnosed
with ovarian cancer at some point during their lifetime (2010 –
2012 data). The prevalence of ovarian cancer in the U.S. is
about 192,000 women, and the five-year survivorship for women with
ovarian cancer is 45.6%.
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 25.1
per 100,000 women in the U.S., with an estimated 54,870 cases for
2015. Although endometrial cancer represents about 3.3% of all
cancers, it represents about 1.7% of all cancer deaths, or an
estimated 10,170 deaths in 2015. Approximately 2.8% of women
will be diagnosed with endometrial cancer at some point during
their lifetime (2010 – 2012 data). The prevalence of
endometrial cancer in the U.S. is about 620,000 women, and the
five-year survivorship for women with endometrial cancer is
81.7%.
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 targeted oncology
therapeutics that address major unmet medical needs. Galena’s
development portfolio is focused primarily on addressing the
rapidly growing patient populations of cancer survivors by
harnessing the power of the immune system to prevent cancer
recurrence. The Company’s pipeline consists of multiple mid- to
late-stage clinical assets, including novel cancer immunotherapy
programs led by NeuVax™ (nelipepimut-S) and GALE-301. NeuVax
is currently in a pivotal, Phase 3 breast cancer clinical trial
with several concurrent Phase 2 trials ongoing both as a single
agent and in combination with other therapies. GALE-301 is in a
Phase 2a clinical trial in ovarian and endometrial cancers and in a
Phase 1b given sequentially with 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 and GALE-302, 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) 498-7709ir@galenabiopharma.com
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