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 the NeuVax™ (nelipepimut-S) Phase 2 clinical trial
entitled VADIS: Phase 2 trial of the Nelipepimut-S Peptide
VAccine in Women with
DC
IS of the Breast is now open
for enrollment and screening patients. The trial is being run in
collaboration with the National Cancer Institute (NCI) and The
University of Texas MD Anderson Cancer Center Phase I and II
Chemoprevention Consortium.
Ductal Carcinoma in Situ (DCIS) is a noninvasive cancer in which
abnormal cells are found in the lining of the breast duct and have
not spread outside the milk duct to invade other parts of the
breast. In some cases, DCIS may become invasive cancer and spread
to other tissues; currently it is extremely challenging to identify
which lesions may convert to invasive cancer.1 DCIS is the
most common type of breast cancer and the rate at which DCIS is
diagnosed has increased dramatically in recent years as a result of
increased cancer screening.1
“The Phase 2 VADIS trial will broaden the development footprint
for NeuVax into this new indication as we assess its safety and
immunologic efficacy in patients with DCIS,” said Mark W. Schwartz,
Ph.D., President and Chief Executive Officer. “The challenge
with DCIS is that the exact course of the disease cannot be
determined and consequently the outcomes for patients may be
undefined. This study will evaluate NeuVax in its capacity to
generate the immune response, including tumor-infiltrating
lymphocytes (TILs), that could potentially prevent the progression
of the disease. Positive study results from the VADIS trial could
provide potential evidence for NeuVax as a first of its kind
treatment for the primary prevention of invasive breast cancer,
thereby sparing significant numbers of women from disfiguring
surgery and radiation treatments. We are grateful to be
working on this innovative initiative with the NCI and the MD
Anderson Cancer Center, two of the finest oncology institutions in
the country.”
Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor,
Department of Breast Surgical Oncology, The University of Texas MD
Anderson Cancer Center and the Principal Investigator of the VADIS
trial, added, “We are pleased to collaborate with the NCI and
Galena on the development of NeuVax in DCIS which affects more than
60,000 women a year. In breast cancer, DCIS may be a precursor to
invasive disease, and it is possible that vaccination before tumor
cells become genetically unstable and begin dividing rapidly could
prevent evolution to malignancy. NeuVax is currently the most
advanced breast cancer vaccine in the clinic and we think its broad
immune response not only to the specific antigen targeted by the
drug, but also to other antigens, speaks to why NeuVax could be an
ideal therapeutic candidate in this indication. By vaccinating
patients in early-phase disease, we may be giving them long-lasting
immunity to protect them down the line.”
The MD Anderson Consortium is funded through the Division of
Cancer Prevention at the NCI, which will provide financial and
administrative support for the trial. Galena will provide
NeuVax, as well as some financial and administrative support.
Source: 1Pang, J-MB, et al, Histopathology 2016.
About VADIS
VADIS (Phase 2 trial of the Nelipepimut-S Peptide
VAccine in Women with
DCIS of the Breast) is a Phase 2
trial to evaluate women diagnosed with DCIS who are HLA-A2
positive, who express HER2 at IHC 1+, 2+, or 3+ levels, and who are
pre or post menopausal. Patients will be randomized to one of
two arms (n=48): NeuVax plus GM-CSF (n=32 randomized / 27
evaluable) or GM-CSF alone (n=16 randomized / 13 evaluable).
The primary endpoint is immunologic and will evaluate the effect of
the NeuVax vaccine on NeuVax -specific cytotoxic T lymphocytes to
determine whether long-lasting immunity is induced. Secondary
endpoints include evaluation of toxicity, In vivo immune response
(delayed type hypersensitivity reaction (DTH)), epitope spreading,
T-cell functional capacity, and histologic response measured by
degree of lymphocyte infiltration, proliferation, and
apoptosis.
The trial design via poster presentation is available on the
Company’s website here. Additional information on the trial can be
found on the ClinicalTrials.gov site here (identifier:
NCT02636582).
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; currently 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 2015 there were over
60,000 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. The nelipepimut-S
sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs)
following binding to specific HLA molecules on antigen presenting
cells (APCs). 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 also 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). A Phase 2
clinical trial is planned in patients with gastric cancer.
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, 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.
Source: Galena Biopharma, Inc.
Contact:
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
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