Galena Biopharma Collaborates With the National Cancer Institute on a Phase 2 Clinical Trial With NeuVax(TM) (nelipepimut-S) ...
September 30 2015 - 7:05AM
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 a collaboration with the
National Cancer Institute (NCI) to initiate a new, Phase 2 clinical
trial with NeuVax™ (nelipepimut-S) in patients diagnosed with
Ductal Carcinoma in Situ (DCIS). The trial will be entitled, VADIS:
Phase 2 trial of the Nelipepimut-S Peptide
VAccine in Women with
DC
IS of the Breast. The
University of Texas M.D. Anderson Cancer Center (MDACC) Phase I and
II Chemoprevention Consortium is the lead for this multi-center
trial with Elizabeth Mittendorf, MD, PhD serving as the study
Principal Investigator. The Consortium is funded through the
Division of Cancer Prevention at NCI, which will provide financial
and administrative support for the trial. Galena will provide
NeuVax, as well as additional financial and administrative support.
The trial is expected to initiate in the fourth quarter of 2015.
"We are pleased to have been chosen by the NCI and M.D.
Anderson, two world-renowned institutions, on this groundbreaking
study to potentially advance NeuVax earlier in the treatment cycle
towards primary prevention of breast cancer," said Mark W.
Schwartz, PhD, President and Chief Executive Officer. "NeuVax
generates a significant and potent HER2 directed T-cell response,
and this Phase 2 clinical trial will evaluate the CD8+ T cell
response generated by NeuVax and whether this induced activation of
the immune system suppresses the growth of DCIS cells. We look
forward to initiating this trial with our partners before year
end."
The Phase 2 clinical trial will be a single-blind, double arm,
randomized, controlled trial comparing NeuVax combined with the
immunoadjuvant granulocyte-macrophage colony-stimulating factor
(GM-CSF) versus GM-CSF alone. Adult women eligible for the trial
will be pre- or post-menopausal with DCIS diagnosed via their core
needle biopsy and will be positive for the human leukocyte antigen
(HLA) allele A2, or HLA-A2 positive. The trial will enroll a total
of 48 patients randomized in a 2:1 ratio, 32 in the active arm and
16 in the control arm. After completion of local therapy to include
surgery and when indicated, radiation, the treatment regimen will
consist of three doses prior to, and three doses after surgery, for
a total of six injections of either vaccine or control, depending
on the arm in which the patients are randomized. The primary
endpoint for the trial is immunological, evaluating NeuVax
peptide-specific cytotoxic T lymphocyte (CTL; CD8+ T cell) response
in vaccinated patients compared to patients receiving GM-CSF alone.
Secondary endpoints include safety, immune response via epitope
spreading, presence of DCIS at resection, and difference in HER2
expression.
The NCI's Division of Cancer Prevention (DCP) conducts and
supports research to determine a person's risk of cancer and to
find ways to reduce the risk. This knowledge is critical to making
progress against cancer because risk varies over the lifespan as
genetic and epigenetic changes can transform healthy tissue into
invasive cancer. With an overall goal to detect such changes and
intervene early in the cancer process to prevent symptomatic
disease and death, DCP funds and provides administrative support to
clinical and laboratory researchers, community and
multidisciplinary teams, and collaborative scientific networks.
About Ductal Carcinoma in
Situ
Ductal Carcinoma in Situ (DUK-tul KAR-sih-NOH-muh in SY-too), or
DCIS, is defined by the NCI as a noninvasive condition in which
abnormal cells are found in the lining of a breast duct, and is the
most common type of breast cancer. The abnormal cells have not
spread outside the duct to other tissues in the breast. In some
cases, DCIS may become invasive cancer and spread to other tissues,
and at this time, there is no way to know which lesions could
become invasive. Current treatment options for DCIS include
breast-conserving surgery and radiation therapy with or without
tamoxifen, breast-conserving surgery without radiation therapy, or
total mastectomy with or without tamoxifen. According to the
American Cancer Society, in 2014 there were an estimated 51,933
diagnoses of ductal carcinoma in situ.
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.
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 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 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 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, 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
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Mar 2024 to Apr 2024
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Apr 2023 to Apr 2024