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 the primary analysis from the Company’s GALE-301 Phase
1/2a clinical trial at the American Society of Clinical Oncology
Annual Meeting 2016. GALE-301 is a cancer immunotherapy
consisting 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 ovarian and endometrial cancer patients in the adjuvant
setting.
The poster, entitled, “The primary analysis of a phase I/IIa
dose finding trial of a folate binding protein vaccine, E39 +
GM-CSF in ovarian and endometrial cancer patients to prevent
recurrence,” demonstrated that the vaccine is well tolerated and
immunogenic. In the optimal dose group, the results demonstrate
potential clinical benefit for GALE-301 to prevent recurrence in
these patients, and that boosters may sustain this effect.
The Phase 1/2a trial began as a dose-escalation Phase 1 trial,
transitioning to a Phase 2a comparing expanded dose cohorts with a
total of 51 patients enrolled, n=29 in the vaccine group (VG) and
n=22 in the control group (CG). After a median follow-up of
16 months, the overall recurrence rate was 44.8% in the VG versus
54.5% in the CG (p=0.58), with a recurrence rate of only 23.5% in
those patients who received booster inoculations. The estimated
two-year disease free survival (DFS) is 46.3% in the VG versus
38.1% in the CG (p=0.36). Importantly, in the optimally dosed group
(OPT) that received the primary vaccine series (PVS) with 1000 mcg
of peptide, there was a significant survival benefit with the
estimated 2-year DFS at 73.5% in the VG (n=15), versus 38.1% in the
CG (n=22) (p=0.03).
“The GALE-301 data presented today reaffirms our strategy to
prevent recurrence of cancer in patients treated with their
standard of care therapy who have limited options besides watch and
wait,” said Bijan Nejadnik, M.D., Executive Vice President and
Chief Medical Officer. “Although small numbers, in our Phase
1/2a trial we were able to see a statistically significant survival
benefit with an estimated two-year disease free survival rate of
over 70% in the patients optimally treated with our GALE-301
vaccine.”
Of the 51 patients, all entered the trial with no evidence of
disease with 40 enrolled after completion of standard of care
treatment for their primary diagnosis and 11 after completion of
standard of care treatment for the recurrence of their
disease. A further subset analysis was completed comparing
the DFS of patients with primary or recurrent disease at
enrollment. The survival benefit observed in the optimally dosed
group persisted in the primary disease patients (DFS: OPT 66.7%
versus CG 36.7%, p=0.02) but not in the recurrent patients (DFS:
OPT 33.3% versus CG 22.2%, p=0.96).
“We are currently running trials in ovarian, endometrial and
breast cancer patients with both E39 (GALE-301) and the attenuated
version of the peptide, E39’ (GALE-302), combined with GM-CSF.
These ongoing studies are designed to assess the best vaccination
strategy to optimize an FBP-specific anti-tumor immune response and
to identify the appropriate patient populations where these agents
can have the most clinical benefit. Our results continue to
show the strength of the science and will guide the best path
forward forward for these compounds,” added COL (ret) George E.
Peoples, MD, FACS, Professor (adjunct) of Surgical Oncology at The
University of Texas MD Anderson Cancer Center, Founder and Director
of Cancer Insight and the Cancer Vaccine Development Program, and
co-inventor of the GALE-301 and GALE-302 compounds.
In the Phase 1/2a trial, HLA-A2 positive patients were
vaccinated and HLA-A2 negative patients were prospectively followed
as a control group. The VG received six monthly inoculations of E39
+ 250 mcg GM-CSF as the PVS, followed by two boosters every six
months. Of the 29 vaccinated patients, 24 completed the PVS, 17
received one booster, and 14 received two boosters. There were no
clinicopathologic differences between groups with primarily grade 1
and grade 2 toxicities. The three most common toxicities were
injection site erythema, skin induration and pruritus, which
occurred in all vaccinated patients. Immunologic evaluation was
performed as a delayed type hypersensitivity (DTH) reaction pre-
and post- PVS. Overall, DTH increased pre- to post-PVS in
vaccinated patients (5.9+1.5 mm vs 11.7+3.2 mm, p=0.07), with a
larger increase seen in the optimally dosed patients (3.8+2.0 mm vs
9.5+3.5 mm, p=0.07) versus those not optimally dosed (7.8+2.1 mm v
11+5.0 mm, p=0.24). Demographic, safety, immunologic, and
recurrence data were collected and analyzed using the appropriate
statistical tests.
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) 498-7709
ir@galenabiopharma.com
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