Galena Biopharma Presents Preclinical NeuVax™ (nelipepimut-S) Data in Ovarian and Pancreatic Cancer at the Progress in Vacc...
13 September 2016 - 11:50PM
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of hematology
and oncology therapeutics that address unmet medical needs, today
announced that preclinical data from the Company’s NeuVax™
(nelipepimut-S) program is being presented today at the Progress in
Vaccination Against Cancer (PIVAC) Conference in Winchester,
UK. NeuVax contains the immunodominant peptide derived from
the extracellular region of the HER2 protein, which is expressed in
ovarian and pancreatic cancers as well as in breast cancer.
The poster, entitled, “Preclinical study on the efficacy of
NeuVax peptide vaccine against human Her2+/ HLA-A2.1+ ovarian and
pancreatic cancer,” demonstrated the results of HLA-A2 transgenic
mice that were immunized with NeuVax (E75) mixed with recombinant
mouse GM-CSF (NeuVax mice). As control, a group of mice received
GM-CSF alone (control mice). CD8+ T cells purified from the spleens
of HLA-A2 transgenic immunized mice were adoptively transferred to
NSG (NOD/SCID/IL2Rγnull) mice bearing human ovarian or pancreatic
tumors which were HER2+, HLA-A2+.
Administration of the NeuVax vaccination resulted in a specific,
delayed-type hypersensitivity (DTH) reaction and in the induction
of E75 specific CD8+ T cells that express PD-1 (programmed T-cell
death protein). Both ovarian and pancreatic tumor growth rate was
significantly reduced in NSG mice that received the CD8+ T cells
from NeuVax-immunized mice compared to those receiving CD8+ T cells
from control mice. Additionally, PD-1 was identified on activated
CD8+ T cells.
“The findings from this preclinical mouse model provide
scientific bases about the efficacy of NeuVax vaccination in
hampering ovarian and pancreatic tumor progression by showing both
DTH reactions and NeuVax specific CD8+ T cells,” said Bijan
Nejadnik, M.D., Executive Vice President and Chief Medical Officer.
“Importantly, the expression of PD-1 on activated CD8+ T cells
suggests an opportunity to investigate the efficacy of NeuVax in
combination with PD-1 inhibitors. We appreciate the work and
dedication on this study run by our partners at the University of
Torino in Italy.”
The abstract (#2) can be found on the conference website here,
and the poster presentation from the conference will be available
on Galena’s website here.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed
cancer immunotherapy currently 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. In clinical studies, NeuVax is combined with recombinant
granulocyte macrophage-colony stimulating factor (GM-CSF).
NeuVax is currently in two breast cancer studies 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 Ovarian Cancer1
New cases of ovarian cancer occur at an annual rate of 11.9 per
100,000 women in the U.S., with an estimated 22,280 new cases and
14,240 deaths in 2016. Approximately 46.2% of ovarian cancer
patients are expected to survive five years after diagnosis.
Approximately 1.3% of women will be diagnosed with ovarian cancer
at some point during their lifetime (2010 – 2012 data). The
prevalence data from 2013 showed an estimated 195,767 women living
with pancreas cancer in the United States.
About Pancreatic Cancer1
New cases of pancreatic cancer occur at an annual rate of 12.4
per 100,000 men and women in the U.S., with an estimated 53,070 new
cases and 41,780 deaths in 2016. Only 7.7% of pancreatic
cancer patients are expected to survive five years after diagnosis.
Approximately 1.5 percent of men and women will be diagnosed with
pancreas cancer at some point during their lifetime (2010-2012
data). The prevalence data from 2013 showed an estimated
49,620 people living with pancreas cancer in the United States.
1National Cancer Institute Surveillance, Epidemiology, and End
Results Program
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company committed
to the development and commercialization of hematology and oncology
therapeutics that address unmet medical needs. Galena’s pipeline
consists of multiple mid-to-late-stage clinical assets led by its
hematology asset, GALE-401, and novel cancer immunotherapy programs
including NeuVax™ (nelipepimut-S) and GALE-301/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, 2015 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.
Contact:
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@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