- GALE-301 is well-tolerated and elicits a strong and
dose-dependent in vivo immune response; 1000 mcg identified as
optimal dose
- In the 1000 mcg vaccine dose group (VG), the clinical
recurrence rate is 13.3% versus 55% in the control group (CG)
(p=0.02), providing for a two-year Disease Free Survival estimate
of 85.7% (VG) versus 33.6% (CG), p<0.02
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 that data from the
GALE-301 Phase 2a portion of the Phase 1/2a clinical trial was
presented at the European Cancer Congress 2015 in Vienna, Austria.
GALE-301 is Galena's cancer immunotherapy that consists of a
peptide (E39) derived from Folate Binding Protein (FBP). GALE-301
is combined with the immune adjuvant, granulocyte macrophage-colony
stimulating factor (GM-CSF) and administered via intradermal
injection for the prevention of recurrence in ovarian and
endometrial cancers.
Poster #P427 (abstract #2764), entitled "Preliminary results of
the phase I/IIa dose finding trial of a folate binding protein
vaccine GALE-301 (E39) + GM-CSF in ovarian and endometrial cancer
patients to prevent recurrence," provided updated data for all
patients who have received at least twelve months of
treatment. As presented, the clinical recurrence rate based on
all treatment cohorts was 41% in the Vaccine Group (VG) (n=29)
versus 55% in the Control Group (CG) (n=22), p=0.41. However,
in the 1000 mcg VG cohort (n=15), there have only been two clinical
recurrences (13.3% versus 55% CG, p=0.02), and the two-year Disease
Free Survival (DFS) estimate is 85.7% (1000 mcg patients) versus
33.6% (CG), p<0.02, as compared by Kaplan-Meir and Log rank
tests.
"This one-year data from our GALE-301 trial is extremely
encouraging as it has established the optimal dose while
demonstrating clear signs of improvement in the disease free status
of women with endometrial and ovarian cancer in the 1000 mcg
cohort," said Mark W. Schwartz, Ph.D., President and Chief
Executive Officer. "More than 70,000 women will be diagnosed
with ovarian or endometrial cancer this year, and we are focused on
preventing their cancer from returning once they receive their
initial treatments. Based on the data presented today, we
expect to meet with the FDA to discuss a potential path forward to
move GALE-301 into a prospective, randomized trial in ovarian and
endometrial cancer patients to prevent recurrence."
The clinical trial program for GALE-301 began as a Phase 1 3x3,
safety and dose-escalation (100, 500, 1000 mcg of E39) trial and
transitioned to a Phase 2a, expanding the optimal dose
cohort. Disease-free endometrial and ovarian cancer patients
were enrolled after receiving their standard of care
therapy. HLA-A2+ patients were vaccinated (VG), and HLA-A2-
patients followed prospectively as a CG. Six monthly intradermal
inoculations of GALE-301 (E39) + 250 mcg GM-CSF were administered
followed by two boosters, one every six months. A total of 51
patients were enrolled: 29 VG and 22 CG. Of the 29 VG
patients, 15 received the optimal dose of 1000 mcg, and 14 patients
received a suboptimal dose of less than 1000 mcg.
"The data presented at the European Cancer Congress reveal that
E39 + GM-CSF is well tolerated and elicits a strong and
dose-dependent in vivo immune response. Early efficacy results
are promising in the optimally dosed 1000 mcg cohort, with the
vaccine exhibiting a very favorable safety profile with primarily
Grade 1 and 2 toxicities and no differences in toxicities based on
dose," commented Julia Greene, M.D., post-doctoral fellow with the
Cancer Vaccine Development Program, and the poster presenter.
Demographic, safety, immunologic, and clinical recurrence data
are continuing to be collected. There have been no observable
differences in age, grade, stage, or histology between groups (all
p≥0.1). In vivo immunologic response is being measured by the
delayed type hypersensitivity reaction (DTH) to the E39 peptide.
DTH increased pre- to post-vaccination, and the DTH increase
was larger in the patients who received the 1000 mcg dose.
About GALE-301
GALE-301 is a cancer immunotherapy that consists of a peptide
derived from Folate Binding Protein (FBP) and is combined with the
immune adjuvant, granulocyte macrophage-colony stimulating factor
(GM-CSF) for the prevention of cancer recurrence in the adjuvant
setting. FBP is a well-validated therapeutic target that is
highly over-expressed in ovarian, endometrial and breast cancers.
FBP is the source of immunogenic peptides that can stimulate
cytotoxic T lymphocytes (CTLs) to recognize and destroy
FBP-expressing cancer cells. Enrollment has been completed in the
GALE-301 Phase 2a portion of the Phase 1/2a clinical trial in two
gynecological cancers: ovarian and endometrial adenocarcinomas
(ClinicalTrials.gov Identifier: NCT01580696).
About Ovarian/Endometrial Cancers
New cases of ovarian cancer occur at an annual rate of 12.1 per
100,000 women in the U.S., with an estimated 21,290 cases for 2015.
Although ovarian cancer represents about 1.3% of all cancers, it
represents about 2.4% of all cancer deaths, or an estimated 14,180
deaths in 2015. Approximately 1.3% of women will be diagnosed
with ovarian cancer at some point during their lifetime (2010 –
2012 data). The prevalence of ovarian cancer in the U.S. is
about 192,000 women, and the five-year survivorship for women with
ovarian cancer is 45.6%.
Due to the lack of specific symptoms, the majority of ovarian
cancer patients are diagnosed at later stages of the disease, with
an estimated 75% of women presenting with advanced-stage (III or
IV) disease. These patients have their tumors routinely surgically
debulked to minimal residual disease, and then are treated with
platinum- and/or taxane-based chemotherapy. While many patients
respond to this treatment regimen and become clinically
free-of-disease, the majority of these patients will relapse.
Depending upon their level of residual disease, the risk for
recurrence after completion of primary therapy ranges from 60% to
85%. Unfortunately for these women, once the disease recurs,
treatment options are limited and the disease remains
incurable.
New cases of endometrial cancer occur at an annual rate of 25.1
per 100,000 women in the U.S., with an estimated 54,870 cases for
2015. Although endometrial cancer represents about 3.3% of all
cancers, it represents about 1.7% of all cancer deaths, or an
estimated 10,170 deaths in 2015. Approximately 2.8% of women
will be diagnosed with endometrial cancer at some point during
their lifetime (2010 – 2012 data). The prevalence of
endometrial cancer in the U.S. is about 620,000 women, and the
five-year survivorship for women with endometrial cancer is
81.7%.
Source: National Cancer Institute Surveillance, Epidemiology,
and End Results (SEER) Program
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 GALE-301, 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