Galena Biopharma Expands Patient Population in NeuVax(TM) (nelipepimut-S) and trastuzumab Phase 2b Combination Clinical Trial...
March 26 2015 - 6:05AM
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 human leukocyte
antigen (HLA) - A24+ or HLA-A26+ women are now eligible for
enrollment into the ongoing Phase 2b clinical trial with NeuVax™
(nelipepimut-S) in combination with trastuzumab (Herceptin®;
Genentech/Roche). The trial evaluates node positive and triple
negative, node negative breast cancer patients with
immunohistochemistry (IHC) HER2 1+/2+ expressing tumors who are
disease-free after standard of care therapy.
"Adding patients with HLA-A24 and/or A26 broadens the
utilization of NeuVax in the ongoing Phase 2b combination trial
with trastuzumab," stated principal investigator COL (ret) George
E. Peoples, MD, FACS, Professor, Surgery, Uniformed Services
University and Professor (adjunct), Surgical Oncology, MD Anderson
Cancer Center. "Women with HER2 1+/2+ breast cancer currently have
no other HER2-directed treatment options available to prevent the
recurrence of their disease. We are pleased to expand our
patient eligibility to offer NeuVax to more women, particularly
those of Asian descent where HLA-A24 and A26 are prevalent."
The nelipepimut-S peptide works by binding to specific HLA
proteins, or molecules key to immunological activity and are
involved in the induction of protective T-cell immune
responses. To date, NeuVax has been tested in trials
with patients who are HLA-A2+ or A3+, representing more
than 60% of the North American, European and Chinese
populations. NeuVax has also been shown to bind to HLA-A24 and
A26, which represents an additional 10-15% of the population in the
U.S., but more importantly, represents up to approximately 70% of
the population in Japan.1
"We continuously look for ways to expand the use of NeuVax both
in our current indications as well as in new diseases, and this
protocol enhancement of our combination trial is a perfect example
of these efforts. We are now able to treat more women and the
expanded patient population could significantly increase the
overall market potential for NeuVax worldwide. We are grateful to
Dr. Peoples and all of our investigators for their ongoing efforts
and creativity around the use of our investigational compounds,"
added Mark W. Schwartz, Ph.D., President and Chief Executive
Officer.
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.
In addition to the Phase 2b trial in node positive and triple
negative HER2 IHC 1+/2+ patients (clinicaltrials.gov identifier:
NCT01570036), 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 also has one additional breast cancer
study ongoing with NeuVax in combination with trastuzumab
(Herceptin®; Genentech/Roche): 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. In China and
Japan, the combined incidence of breast cancer is approximately
322,0002. 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 development of Galena's
product candidates, including the conduct, timing and 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, 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.
Sources:
1 http://www.allelefrequencies.net/
2Global Data: PharmaPoint: HER2-Negative Breast Cancer - Global
Drug Forecast and Market Analysis to 2023
CONTACT: Remy Bernarda
SVP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Apr 2024 to May 2024
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From May 2023 to May 2024