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
presented data from an observational study in gastric cancer
patients at the American Society of Clinical Oncology (ASCO) 2016
Gastrointestinal Cancers Symposium in San Francisco, CA. The
study was conducted by Galena’s partner, Dr. Reddy’s Laboratories
Ltd, under the license agreement for NeuVax™ (nelipepimut-S) which
includes the commercialization rights in India. As part of the
license agreement, Dr. Reddy’s will conduct a Phase 2 clinical
trial of NeuVax in gastric cancer patients in India.
“This observational study and the planned Phase 2 clinical trial
in gastric cancer are part of the broad pipeline of NeuVax studies
currently underway and planned,” stated Bijan Nejadnik, Executive
Vice President and Chief Medical Officer of Galena. “Gastric, or
stomach cancer, is the second-most common cancer among males and
third-most among females in Asia and worldwide with over 35,000 new
cases a year in India.1 The planned Phase 2 clinical study will
assess the effectiveness of NeuVax to prevent recurrence and the
effect on the disease free survival in gastric cancer patients with
all levels of HER2 expression and who are HLA A2 and/or A3
positive. The data presented today demonstrated that, as expected,
about 25% of the patient population suffering from gastric cancer
in India are likely to be eligible for the Phase 2 trial.
This study by Dr. Reddy’s supports their plans to run a Phase 2
trial in India.”
This prospective, observational study was undertaken to estimate
the expression of HER2 (1+, 2+, or 3+) with HLA-A2 and/or HLA-A3
type positive gastric cancer patients in the Indian
population. The poster, entitled, “An observational study
evaluating the expression of HER2 (1+, 2+, and 3+) with HLA A2+/A3+
in gastric adenocarcinoma patients” is being presented during
today’s poster session. Of the 50 patients evaluated, 12 (24%) were
positive for HER2 (1+, 2+, 3+) with HLA A2/A3 alleles. Of the 12
patients, 9 (75%) and 3 (25%) expressed HLA A2/A3, respectively,
with no patient demonstrating HER2 3+ expression. Results from this
study suggest patients with gastric or GE junction adenocarcinoma
have HLA A2 and/or A3 expressing tumors with mostly HER2 1+, 2+
expression. The estimated incidence of HER2 3+ expression in
this population may be limited by the size of the current study
(n=50). Approximately 25% of the patients met the projected
clinical protocol population of all levels of expression of HER2
and HLA A2+ and/or A3+ as defined for the planned NeuVax Phase 2
clinical trial. Results indicate an acceptable potential for
enrollment rate, given the high incidence of gastric cancer in this
population, and will inform the screen failure rate in the planned
Phase 2 clinical study.
Tumor tissue samples from gastric or GE junction adenocarcinoma
patients were collected from S. L. Raheja Hospital, Mumbai, India.
A serum sample was collected for HLA testing by quantitative PCR
(polymerase chain reaction). Immunohistochemistry (IHC) (DAKO,
1:600 dilution) was employed for detection of HER2. All patients
were consented for the study.
1Rajesh P. Dikshit, Garima Mathur, Sharayu Mhatre, and B.B.
Yeole; Epidemiological review of gastric cancer in India; Indian
Journal of Medical and Paediatric Oncology 2011 Jan-Mar; 32(1):
3–11.
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 Gastric Cancer
According to the National Cancer Institute, gastric (stomach)
cancer is a disease in which malignant (cancer) cells form in the
lining of the stomach. Almost all gastric cancers are
adenocarcinomas (cancers that begin in cells that make and release
mucus and other fluids). Other types of gastric cancer are
gastrointestinal carcinoid tumors, gastrointestinal stromal tumors,
and lymphomas. Infection with bacteria called Helicobacter pylori
(H. pylori) is a common cause of gastric cancer and age, diet, and
stomach disease can affect the risk of developing gastric cancer.
Gastric cancer is often diagnosed at an advanced stage because
there are no early signs or symptoms.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical
company, committed to accelerating access to affordable and
innovative medicines, because it believes Good Health Can’t Wait.
Through its three businesses - Pharmaceutical Services & Active
Ingredients, Global Generics and Proprietary Products – the company
offers a portfolio of products and services that include active
pharmaceutical ingredients, (APIs), custom pharmaceutical services,
generics, biosimilars and differentiated formulations. With
operations in 26 countries across the globe, the major therapeutic
areas of Dr. Reddy’s are gastro-intestinal, cardiovascular,
diabetology, oncology, pain management and anti-infectives. For
more information, log on to: www.drreddys.com
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 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 NeuVax, 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, 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.
NeuVax is a trademark of Galena Biopharma, Inc.
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
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