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 that data from the
Company's NeuVax™ (nelipepimut-S) and GALE-301 and GALE-302
clinical programs will be presented at two upcoming medical
conferences. Details of the presentations are as follows:
Conference: |
Society for Immunotherapy of Cancer
(SITC) 30th Anniversary Annual Meeting |
Poster #: |
166 |
Abstract #: |
156 – the abstract will be available on
November will be published in the Journal for ImmunoTherapy of
Cancer on Wednesday, November 4, 2015. |
Title: |
Preliminary report of a clinical trial
supporting the sequential use of an attenuated E39 peptide (E39')
to optimize the immunologic response to the FBP (E39+GM-CSF)
vaccine |
Date: |
Friday, November 6, 2015 |
Time: |
6:15 p.m. to 7:30 p.m. Eastern time |
Location: |
Prince George's Exhibition Hall at the
Gaylord National Hotel & Convention Center in National Harbor,
Maryland |
GALE-301 (E39) and GALE-302 (E39' – variant of E39; previously
named J65) are folate binding protein (FB) peptides targeting FBP
expressing tumors. The data to be presented
at SITC is from a single-center, randomized, single-blinded,
three-arm Phase 1b study of GALE-301 and GALE-302 in patients with
breast or ovarian cancer diagnosis who have been treated by
standard of care and are without evidence of disease. The primary
endpoint of the trial is immunological and designed to determine
which of the three primary vaccination sequence strategies
maximizes long-term specific immunity defined as E39-specific
cytotoxic T lymphocytes (CTLs) six months following completion of
the primary vaccination series.
Conference: |
33rd Annual Chemotherapy Foundation
Symposium: Innovative Cancer Therapy for Tomorrow® |
Poster #: |
309 |
Title: |
NeuVax™ (nelipepimut-S) for the prevention
of recurrence in HER2-expressing node positive breast cancer
patients |
Date: |
Wednesday, November 4, 2015 |
Time: |
6:00 p.m. to 7:00 p.m. Eastern time |
Location: |
Crown Plaza Hotel, New York, NY |
In 2014, it is estimated there are 14.5 million cancer survivors
in the United States. By 2024, it is projected there will be 19
million cancer survivors (DeSantis CE et al., 2014). In breast
cancer patients, 50–60% who are HER2 IHC 1+/2+ or FISH < 2.0
achieve a response with current standard of care (SOC), but have no
treatment options to maintain disease-free status. NeuVax is being
studied to prevent breast cancer recurrence in these women in the
adjuvant setting and maintain patients' "survivor" status as a
single agent in node positive as well as in combination with
Herceptin® in node positive and triple negative disease (IHC 1+/2+)
as well as high risk node positive and triple negative (IHC3+).
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 prime
(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 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. 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). PRESENT is targeting node positive
HER2 IHC 1+/2+ patients (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 high risk, node positive or
negative HER2 IHC 3+ patients (clinicaltrials.gov identifier:
NCT02297698). Phase 2 clinical trials with NeuVax are also
planned in patients with ductal carcinoma in situ (DCIS), and in
patients with gastric cancer.
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 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 our
commercial products and development of Galena's product candidates,
including NeuVax, 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 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,
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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