Galena Biopharma Presents HER2 Screening Data Including Preliminary Leica Bond Oracle(TM) Results From the Phase 3 NeuVax(TM)...
December 11 2014 - 8:35AM
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major medical needs across the full
spectrum of cancer care, today announced that initial
immunohistochemistry (IHC) screening data from the NeuVax™
(nelipepimut-S) Phase 3 PRESENT (
Prevention of
Recurrence in
Early-
Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2
Expression
with
NeuVax Treatment) trial was
presented at the 2014 San Antonio Breast Cancer Symposium (SABCS).
The poster, entitled, "HER2 Discordant Results in Local vs.
Central Testing in the Phase 3 Nelipepimut-S Trial and
Implementation of Leica Bond Oracle HER2 Immunohistochemistry (IHC)
System for Low and Intermediate Levels (1+, 2+) of HER2 Protein
Expression as a Companion Diagnostic," demonstrated that with the
implementation of the Leica Bond Oracle HER2 IHC assay, preliminary
limited data indicated additional patients met HER2 eligibility for
PRESENT and the assay identified more precisely patients at HER2 1+
and 2+.
As part of the PRESENT trial, Galena has implemented central
laboratory testing for all potential patients to confirm validated
and robust entry criteria, and 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 IHC system has
been incorporated as central HER2 IHC screening for the PRESENT
study.
Mark W. Schwartz, Ph.D., President & CEO of Galena,
commented, "NeuVax is a highly specific, directed immunotherapy
targeting the HER2 1+/2+ adjuvant breast cancer patient population
where there are no HER2 directed treatment options. Currently
approved HER2 agents only target HER2 overexpressing (IHC 3+)
breast cancers. As a result, the companion diagnostic tests
are only approved to assess IHC 3+ expression of HER2, and there
are currently no companion IHC diagnostic tests approved to
distinguish between patients who are HER2 IHC 0, 1+, or 2+."
Dr. Schwartz continued, "Given these factors, there is a need to
establish a companion diagnostic to show an accurate distinction
across all levels of HER2. We are working closely with our
partners at Leica utilizing central testing confirmation of the
patient samples to ensure that we are enrolling and treating the
right patient population in the PRESENT trial, with the hope of
offering personalized medicine for these women to prevent their
breast cancer recurrence."
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is the immunodominant peptide derived
from the extracellular domain of the HER2 protein, a
well-established target for therapeutic intervention in breast
carcinoma. The nelipepimut-S sequence stimulates specific CD8+
cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3
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. Galena has two
additional breast cancer trials ongoing with NeuVax in combination
with Herceptin® (trastuzumab; Genentech/Roche): a Phase 2b in node
positive and triple negative HER2 IHC 1+/2+, and a Phase 2 in
neoadjuvant node positive & negative HER2 IHC 3+.
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 NeuVax™
(nelipepimut-S), patient enrollment 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, 2013 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.
CONTACT: Remy Bernarda
VP, Marketing & Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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