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
announced the U.S. Food and Drug Administration (FDA) has
designated NeuVax™ (nelipepimut-S), combined with recombinant
granulocyte macrophage-colony stimulating factor (GM-CSF), as a
Fast Track development program for the treatment of patients with
early stage, node positive breast cancer with low to intermediate
HER2 expression, otherwise known as HER2 1+ or 2+, following
standard of care. Galena’s PRESENT (
Prevention of
Recurrence in
Early-
Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2
Expression
with
NeuVax Treatment) clinical
trial is an international, Phase 3 study to evaluate NeuVax plus
GM-CSF versus placebo plus GM-CSF to prevent cancer recurrence.
“This Fast Track designation by the FDA reflects the importance
of NeuVax as a potential treatment option addressing an unmet
medical need in a serious medical condition,” said Mark W.
Schwartz, Ph.D., President and Chief Executive Officer. “With
the number of cancer survivors in the United States projected to
increase by 31% to almost 19 million by 20241, there is a clear
need to prevent recurrence in women with breast cancer who have
completed their standard of care, but have limited therapies to
maintain their disease free status. As we approach our
interim safety and futility analysis for PRESENT, and initiate our
efforts towards the filing of a Biologics License Application
(BLA), this Fast Track designation will be extremely valuable to us
as we seek marketing authorization for NeuVax.”
“Fast Track designation provides us with opportunities for
frequent interactions with the FDA review team for our NeuVax
development program in breast cancer, including the PRESENT trial,
as we prepare our BLA for filing. As such, assuming a successful
clinical readout in the PRESENT trial, we may be eligible for a
rolling review. We look forward to collaborating closely with the
FDA at this critical stage for NeuVax development,” added Bijan
Nejadnik, M.D., Executive Vice President and Chief Medical
Officer.
The Fast Track designation provides for the designation of a
drug as a fast track product if it is intended for the treatment of
a serious or life-threatening disease or condition, and it
demonstrates the potential to address unmet medical needs for such
a disease or condition.2 This designation is intended to facilitate
development and expedite review of drugs to treat serious and
life-threatening conditions so that an approved product can reach
the market expeditiously.3 Designation as a Fast Track product
means that the FDA will take such actions as are appropriate to
expedite the development and review of the application for approval
of such product. If FDA determines, after preliminary evaluation of
clinical data submitted by a sponsor, that a fast track product may
be effective, the Agency may consider reviewing portions of a
marketing application before the sponsor submits the complete
application (rolling review).4 In addition, such a product could be
eligible for priority review if supported by clinical data at the
time of BLA submission.5
Sources: 1ASCO Connection, October 28, 2014: From Patient to
Survivor: ASCO Programs and Resources for Cancer Survivorship
Continue to Grow2-5FDA Guidance for Industry on Expedited Programs
for Serious Conditions – Drugs and Biologics
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. In clinical studies, NeuVax is combined with
recombinant granulocyte macrophage-colony stimulating factor
(GM-CSF).
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 PRESENT
PRESENT (Prevention of
Recurrence in
Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression
with NeuVax Treatment) is an
international, Phase 3 study to evaluate NeuVax plus GM-CSF versus
placebo plus GM-CSF to prevent cancer recurrence. The trial
is being run under a Special Protocol Assessment (SPA) granted by
the U.S. Food and Drug Administration (FDA). PRESENT is targeting
patients who are node positive, HER2 IHC 1+/2+, and HLA A2+ and/or
A3+. The study is double blind, randomized 1:1, and is
stratified by stage, type of surgery, hormone receptor status, and
menopausal status. Galena enrolled a total of 758 patients who
constitute the Intention to Treat (ITT) population, and the primary
endpoint for the trial is disease free survival (DFS) upon reaching
141 events with 3 years minimum follow-up. Additional
information on the trial can be found here and at
clinicaltrials.gov identifier: NCT01479244.
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. 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. 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 breast cancer 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, 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
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