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 that the 70th qualifying disease free survival (DFS)
event has been achieved in the NeuVax™ (nelipepimut-S) Phase 3,
PRESENT (
Prevention of
Recurrence
in
Early-
Stage, Node Positive
Breast Cancer with Low to Intermediate HER2
Expression with
NeuVax
Treatment) clinical trial. NeuVax is a peptide
immunotherapy vaccine currently being evaluated for the prevention
of cancer recurrence and is Galena’s lead development agent in
multiple ongoing and planned clinical trials.
Based on clinical and radiological data, seventy qualifying DFS
events have been confirmed by the trial’s independent Endpoint
Adjudication Committee (EAC), comprised of two oncologists and one
radiologist with expertise in the conduct of clinical trials in
breast cancer. In the ensuing months, Galena will compile and
submit the clinical data to the trial’s Independent Data Monitoring
Committee (IDMC) to perform the Interim Analysis. The Interim
Analysis is a pre-specified futility and overall safety analysis to
evaluate the likelihood of the study to achieve its primary
objectives. Upon completion of this prospective analysis, the IDMC
will provide a recommendation to the Company regarding further
continuation of the trial.
“We are pleased that we have achieved this important milestone
in the PRESENT trial and that the rate of recurrences are in line
with the original assumptions that led to the study design,” stated
Bijan Nejadnik, M.D., Executive Vice President and Chief Medical
Officer. “Reaching the 70th qualifying DFS event triggers the
pre-planned Interim Analysis. We will now prepare the data package
for the IDMC in order for the committee to evaluate the safety of
NeuVax for all patients enrolled, perform a futility analysis, and
provide its recommendation on continuing the trial. We
anticipate reaching this next milestone in the PRESENT trial at the
end of the second quarter.”
Dr. Nejadnik continued, “The 70th event also represents a
significant maturation of the program and is a meaningful time
point as it brings us halfway to the full number of 141 events
required for the primary endpoint analysis in conjunction with
three years minimum follow-up. I am grateful to our clinical team,
our committee’s physician experts, and our trial sites, as they
have been instrumental in achieving this milestone. With this
point of progress in the trial, we are assembling our internal
teams responsible for drafting our Biologics License
Application.”
For the PRESENT trial, a qualifying DFS event is defined as: a
recurrence of the primary breast cancer, either locally in the
breast, regionally in the lymph nodes, or distantly as metastatic
disease; an occurrence of another cancer; or, death from any cause.
All qualifying DFS events are confirmed by the EAC. The IDMC is
comprised of two medical oncologists, one cardiologist, and one
statistician and will perform the Interim Analysis.
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 granulocyte
macrophage-colony stimulating factor (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 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 addition to PRESENT, Galena also has two 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 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 including the Phase 3 trial for NeuVax,
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) 498-7709ir@galenabiopharma.com
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