Galena Biopharma to Present NeuVax™ (nelipepimut-S) plus Trastuzumab Interim Safety Data at the European Society for Medica...
October 10 2016 - 7:05AM
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of hematology
and oncology therapeutics that address unmet medical needs,
presented interim safety data from the Company’s NeuVax™
(nelipepimut-S) Phase 2b combination study with trastuzumab at the
European Society for Medical Oncology (ESMO) 2016 Congress in
Copenhagen, Denmark. The clinical trial is a randomized,
multicenter, investigator-sponsored, 300 patient Phase 2b study. It
is currently enrolling HER2 1+ and 2+ node positive, and high-risk
node negative patients to study NeuVax in combination with
trastuzumab to prevent breast cancer recurrence.
Poster #1069P, entitled “Interim safety analysis of a phase II
trial combining trastuzumab and NeuVax, a HER2-targeted peptide
vaccine, to prevent breast cancer recurrence in HER2 low
expression,” demonstrated that this novel combination of
trastuzumab and NeuVax in HER2 low-expressing (LE) patients is
well-tolerated and the cardiac effects of trastuzumab are not
impacted by the addition of NeuVax.
In March 2016, the 150th patient was randomized into the trial,
triggering this pre-specified safety analysis (Vaccine Group (VG)
n=81, Control Group (CG) n=69). There were no significant
differences in treatment factors, but a significant difference in
node positivity appreciated between the groups. The sponsor
expects this randomization imbalance to equalize over the duration
of the study. Cardiac ejection fraction (EF) was assessed at
baseline and serially throughout treatment. The majority of
toxicities were Grade 1 and 2, and there was no difference between
treatment arms. There was no difference in EF over time (baseline
(T0) to 6mo (T6)) between VG v CG (T0: 61.4+0.6%, T6: 60.5+0.9% v
T0: 61.6+0.7%, T6: 60.7+1.0%, p=0.9). There was one CG
patient who experienced a grade 3 cardiac adverse event, but their
EF returned to baseline after discontinuation of trastuzumab.
“This pre-specified, interim safety analysis is crucial to this
trial to ensure that the combination of NeuVax and trastuzumab is
well-tolerated in patients, and importantly that it does not
increase the cardio-toxicity effects known to be associated with
trastuzumab,” said Bijan Nejadnik, M.D., Executive Vice President
and Chief Medical Officer. “There is a growing consensus that
combination therapies may yield the greatest clinical benefit, and
this Phase 2b trial remains ongoing with enrollment expected to
complete by the end of this year. As a result, we expect to
report our first interim efficacy and immunologic outcomes after 12
months of follow-up, currently expected at the end of 2017.
We are grateful to Dr. George Peoples and his team who continue
this groundbreaking work.”
Disease-free, HLA-A2+, A3+, A24+, or A26+, HER2 LE breast cancer
patients at high risk for recurrence were enrolled after standard
of care treatment and randomized to vaccine group (VG) receiving
trastuzumab and NeuVax or control group (CG) receiving trastuzumab
and GM-CSF only. Trastuzumab dosing was 8mg/kg loading, then 6mg/kg
every 3 weeks. Patients received 6 total inoculations of
NeuVax or GM-CSF, one every 3 weeks starting with the third
trastuzumab infusion, followed by four booster inoculations
administered every 6 months. Demographic and safety data were
collected and analyzed with appropriate statistical tests.
The poster presentation from the conference will be available on
Galena’s website here.Abstract #3981 can be found on the conference
website here.
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 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 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 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. Herceptin is a
trademark of Genentech/Roche
Contact:
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
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