- GALE-301 demonstrates promising preliminary efficacy data with
a projected 78% reduction in relative risk of recurrence in the
1000 mcg dose cohort
- Leica Biosystem's Bond Oracle HER2 Immunohistochemistry (IHC)
System distinguishes HER2 1+ and 2+ expressions and supports its
use as a companion diagnostic for NeuVax™ (nelipepimut-S)
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
therapeutics that address major medical needs across the full
spectrum of cancer care, today announced two abstract publications
at the American Society of Clinical Oncology (ASCO) 2015 Annual
Meeting.
"The two abstracts published by ASCO provide meaningful
advancements for both of our cancer immunotherapy programs, NeuVax
and GALE-301," said Mark W. Schwartz, Ph.D., President and Chief
Executive Officer. "The use of Leica's Bond Oracle HER2 IHC system
ensures we have enrolled the specified HER2 1+/2+ patients for our
Phase 3 NeuVax™ PRESENT trial and moves us further down the path of
providing targeted, personalized medicine for these women.
Meanwhile, the published preliminary data from our GALE-301 program
is quite promising as it shows significant reduction of recurrences
with our vaccine. We expect to present more mature data at a
scientific conference this Fall, and we are currently evaluating
the next steps to potentially advance GALE-301 into a randomized
late-stage trial to prevent recurrence in ovarian and endometrial
cancers."
GALE-301
GALE-301 (E39) is a cancer immunotherapy targeting folate
binding protein receptor-alpha to prevent ovarian and endometrial
cancer recurrence in the adjuvant setting. In abstract #e14031,
entitled, "Preliminary Results of the Phase I/IIa Dose Finding
Trial of a Folate Binding Protein Vaccine (E39+GM-CSF) in Ovarian
and Endometrial Cancer Patients to Prevent Recurrence," data show
that GALE-301 is well tolerated and elicits a strong and
dose-dependent in vivo immune response. The trial is designed as a
safety and dose optimization trial and is not powered for a disease
free survival efficacy endpoint. However, early efficacy results
from the trial are promising in the 1000 mcg dose cohort. Of the 51
patients enrolled in the trial, 29 were in the vaccinated group (15
patients at 1000 mcg vs. 14 patients at <1000 mcg) and 22 were
in the control group. With 9.8 months median follow-up, the 1000
mcg dose group had only one clinical recurrence vs 11 in the
vaccine group (6.7% vs. 50% CG, p = 0.01). Combining all dose
groups, the complete response (CR) rate was 38% in the vaccine
group vs. 50% in the control group (p = 0.41). Currently, the
estimate for disease free survival at two years is 85.7% (1000 mcg
dose group) vs. 19.2% for the control group (p = 0.09), for a 78%
reduction in relative risk of recurrence. The full abstract can be
found here.
NeuVax™ (nelipepimut-S) Companion
Diagnostic
As part of the Phase 3 PRESENT (Prevention of
Recurrence in
Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression
with NeuVax Treatment) trial, Galena implemented
central laboratory testing for all potential patients to confirm
validated and robust entry criteria, and to ensure the enrollment
of the targeted patient population. To improve accuracy and
specificity for the HER2 1+ and 2+ status testing, and develop a
companion diagnostic for NeuVax, the Leica Bond Oracle™ HER2
Immunohistochemistry (IHC) system has been incorporated as central
HER2 screening for the PRESENT study.
In abstract #e11609, entitled, "Analytical Validation of BOND
Oracle HER2 IHC System for Identifying Low to Intermediate HER2
Expressing Breast Cancer in NeuVax PRESENT Phase 3 Clinical Trial,"
data demonstrate a direct correlation between cell line receptor
load, quantitative measure of HER2 protein, and IHC score. The
ability to discriminate HER2 protein expression at the low and
intermediate levels in breast cancer tumors will identify patients
for new treatments in development such as NeuVax. Specifically, the
validation of the Bond Oracle HER2 IHC System to distinguish lower
levels of HER2+ expressions supports its use as a companion
diagnostic. The full abstract can be found here.
About GALE-301 (Folate Binding Protein)
GALE-301 (Folate Binding Protein (FBP)) is a cancer
immunotherapy targeting the prevention of cancer recurrence in the
adjuvant setting. GALE-301 targets folate binding protein
receptor-alpha, a well-validated therapeutic target, 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. GALE-301 consists of the FBP peptide(s) combined with the
immune adjuvant, granulocyte macrophage-colony stimulating factor
(GM-CSF). Galena has completed enrollment in a Phase 2a trial with
GALE-301 in two gynecological cancers: ovarian cancer and
endometrial adenocarcinomas (clinicaltrials.gov identifier:
NCT01580696).
About Ovarian/Endometrial Cancers
Ovarian cancer occurs in more than 40,000 women per year in the
U.S. and is the most lethal gynecologic cancer. Despite the
incidence of ovarian cancer being only approximately 20% of that of
breast cancer, the number of patients who die from ovarian cancer
is nearly 50% of that of breast cancer. Due to the lack of specific
symptoms, the majority of ovarian cancer patients are diagnosed at
later stages of the 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
most patients respond to this treatment regimen and become
clinically free-of-disease, the majority of these patients will
relapse, and once the disease recurs, treatment options are limited
and successes of subsequent interventions drop dramatically.
Endometrial cancer is the most common gynecologic cancer and
occurs in more than 46,000 women with more than 8,000 deaths in the
U.S. annually. There are two basic types of endometrial cancer:
endometrioid and papillary serous. The latter has a much more
aggressive clinical course and the majority of these patients will
die of this form of the disease.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed
cancer immunotherapy under evaluation to prevent breast cancer
recurrence after standard of care treatment in the adjuvant
setting. It is the immunodominant peptide derived from the
extracellular domain of the HER2 protein, a well-established target
for therapeutic intervention in breast carcinoma. NeuVax has been
shown to bind to HLA-A2 and A3, as well as HLA-A24 and A26
molecules. The nelipepimut-S sequence stimulates specific CD8+
cytotoxic T lymphocytes (CTLs) following binding to specific HLA
molecules on antigen presenting cells (APC). These activated
specific CTLs recognize, neutralize and destroy, through cell
lysis, HER2 expressing cancer cells, including occult cancer cells
and micrometastatic foci. The nelipepimut-S immune response can
also generate CTLs to other immunogenic peptides through inter- and
intra-antigenic epitope spreading.
NeuVax is currently in an international, Phase 3 PRESENT
(Prevention of Recurrence in
Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression
with NeuVax Treatment) study
under a Special Protocol Assessment (SPA) granted by the U.S. Food
and Drug Administration (FDA). Additional information on the
PRESENT trial can be found at www.neuvax.com (clinicaltrials.gov
identifier: NCT01479244). Galena has two additional breast cancer
studies ongoing with NeuVax in combination with trastuzumab
(Herceptin®; Genentech/Roche): a Phase 2b trial in node positive
and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier:
NCT01570036); and, a Phase 2 trial in neoadjuvantly treated node
positive and negative HER2 IHC 3+ patients not achieving a
pathological complete response (pCR) or adjuvantly treated node
positive HER2 IHC 3+ patients (clinicaltrials.gov identifier:
NCT02297698).
About HER2 1+/2+ Breast Cancer
According to the National Cancer Institute, over 230,000 women
in the U.S. are diagnosed with breast cancer annually. Of these
women, only about 25% are HER2 positive (IHC 3+). NeuVax targets
approximately 50%-60% of these women who are HER2 low to
intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission
with current standard of care, but have no available HER2-targeted
adjuvant treatment options to maintain their disease-free
status.
About Leica Biosystems
Leica Biosystems is a global leader in workflow solutions and
automation, striving to advance cancer diagnostics to improve
patients' lives. Leica Biosystems provides anatomical pathology
laboratories and researchers a comprehensive product range for each
step in the pathology process, from sample preparation and staining
to imaging and reporting. Leica's easy-to-use and consistently
reliable offerings help improve workflow efficiency and diagnostic
confidence. The company is represented in over 100 countries. It
has manufacturing facilities in 7 countries, sales and service
organizations in 19 countries, and an international network of
dealers. The company is headquartered in Nussloch, Germany. Further
information can be found at www.LeicaBiosystems.com
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical
company developing and commercializing innovative, targeted
oncology therapeutics that address major medical needs across the
full spectrum of cancer care. Galena's development portfolio ranges
from mid- to late-stage clinical assets, including a robust
immunotherapy program led by NeuVax™ (nelipepimut-S) currently in
an international, Phase 3 clinical trial. The Company's
commercial drugs include Abstral® (fentanyl) Sublingual Tablets and
Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's
clinical and commercial strategy focuses on identifying and
advancing therapeutic opportunities to improve cancer
care, from direct treatment of the disease to the reduction of
its debilitating side-effects. 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 commercialization of Abstral®
and development of Galena's product candidates, including patient
enrollment and preliminary results in our clinical trials, as well
as statements about our expectations, plans and prospects. 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, 2014 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.
Abstral and NeuVax are trademarks of Galena Biopharma,
Inc. All other trademarks are the property of their respective
owners.
CONTACT: Remy Bernarda
SVP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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