Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
developing hematology and oncology therapeutics that address unmet
medical needs, today announced the final analysis from the
Company’s GALE-301 (E39) investigator-sponsored Phase 1/2a clinical
trial. The data was given during an oral presentation by Dr.
Larry Maxwell at the Annual Meeting on Women’s Cancer 2017 hosted
by the Society of Gynecologic Oncology. The presentation was
entitled, “Analysis of a Phase I/IIa Trial Assessing E39+GM-CSF, a
Folate Binding Protein Vaccine, to Prevent Recurrence in Ovarian
and Endometrial Cancer Patients.” GALE-301 is a cancer
immunotherapy consisting of a peptide derived from Folate Binding
Protein (FBP) combined with the immune adjuvant, granulocyte
macrophage-colony stimulating factor (GM-CSF) for the prevention of
cancer recurrence in ovarian and endometrial cancer patients in the
adjuvant setting.
“This final data from our early stage clinical trial
demonstrates that GALE-301 is well tolerated and we were able to
obtain statistically significant disease free survival in a small
number of patients treated with the optimal dose,” said Bijan
Nejadnik, M.D., Executive Vice President and Chief Medical Officer.
“The data also showed a meaningful correlation between delayed type
hypersensitivity reactions and clinical outcomes indicating that
the vaccine is able to generate an immune response. The
results of the trial also reiterate our focus on treating patients
with primary disease after their initial standard of care treatment
where we believe GALE-301 may provide the most benefit. On behalf
of the entire Galena team, we would like to thank Dr. Maxwell and
Dr. George Peoples whose work on our immunotherapy vaccines
targeting FBP have set the stage for potential future trials to
prevent ovarian cancer recurrence.”
The trial began as a dose-escalation Phase 1 trial,
transitioning to a Phase 2a comparing expanded dose cohorts with a
total of 51 patients enrolled, n=29 in the HLA-A2 positive vaccine
group (VG) and n=22 in the HLA-A2 negative control group
(CG). Forty patients were enrolled after standard of care
treatment of primary disease and 11 patients after treatment of
recurrent disease (5 in the VG, 6 in the CG). All patients were
disease-free at enrollment. Following administration of
vaccine, local and systemic toxicities were mild at the completion
of the series with no grade 4 or 5 toxicities, and only 1 patient
experienced grade 3 toxicity, with the most common local toxicities
being induration at the injection site, erythema, and
pruritus. Systemic toxicities for the 1000mcg group did
not show any significant difference as compared to the <1000mcg
group. The most common systemic toxicities were muscle pain,
headache, and fatigue.
The final endpoint for the trial was disease free survival (DFS)
after two years, or 24 months. The overall DFS for the VG (n=29)
was 50% versus 44% for the CG (n=22)(p=0.594). Importantly,
the two-year DFS was significantly higher in the optimally dosed
1000mcg group (n=15) with 77% DFS versus 44% DFS in the CG
(n=22) patients (p=0.05). Patients with primary disease who
received the 1000mcg dose appear to maintain a statistically
significant benefit while those with recurrent disease were not.
Given the small number of patients in the recurrence group, this
finding needs to be confirmed in a larger trial. In the trial,
those patients with a lower expression of FBP performed better with
an 86% DFS in the VG (n=8) versus 18% in the CG (n=11),
p=0.01. This reiterated our prior analysis that high levels
of FBP expression associated with more aggressive disease may
outpace the immune response and diminish the therapeutic effects of
the vaccine. The correlation between delayed type hypersensitivity
(DTH) reactions and clinical outcome was also analyzed. DTH was
significantly increased from pre- to post-vaccination in the group
receiving the optimal dose of 1000 mcg (p=0.03).
The trial was conducted as a prospective Phase 1/2a trial of
E39+GM-CSF to prevent recurrence in disease-free ovarian and
endometrial cancer patients at high risk for recurrence after
standard of care treatments. Eligible patients included patients
with primary or recurrent endometrial, ovarian, fallopian tube, or
peritoneal cancer. Once enrolled, HLA-A2 positive patients
were inoculated with E39+GM-CSF and HLA-A2 negative patients were
followed prospectively as matched controls. The primary vaccination
series consisted of six total vaccinations, one given every 21-28
days, and the dose escalation scheme consisted of dosing cohorts of
3 patients each receiving one of the following doses: 100μg, 500μg,
and 1000μg in addition to 250μg GM-CSF. Two booster
inoculations were given, one every six months. In vivo immune
monitoring was assessed using DTH measured pre- and
post-vaccination. Patients were monitored for evidence of clinical
recurrence every 3 months and the pre-specified intention-to-treat
analysis was performed at 12 and 24 months after the last patient
was enrolled.
About GALE-301
GALE-301 is a cancer immunotherapy that consists of a peptide
derived from Folate Binding Protein (FBP) 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
ovarian and endometrial cancer.
About Ovarian/Endometrial Cancers1
New cases of ovarian cancer occur at an annual rate of 11.9 per
100,000 women in the U.S., with an estimated 22,280 new cases and
14,240 deaths in 2016. Approximately 46.2% of ovarian cancer
patients are expected to survive five years after diagnosis.
Approximately 1.3% of women will be diagnosed with ovarian cancer
at some point during their lifetime (2011 - 2013 data). The
prevalence data from 2013 showed an estimated 195,767 women living
with ovarian cancer in the United States.
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 25.4
per 100,000 women in the U.S., with an estimated 60,050 new cases
and 10,470 deaths in 2016. Approximately 81.7% of endometrial
cancer patients are expected to survive five years after diagnosis.
Approximately 2.8% of women will be diagnosed with endometrial
cancer at some point during their lifetime (2010 - 2013 data).
The prevalence data from 2013 showed an estimated 635,437
women living with endometrial cancer in the United States.
1National Cancer Institute Surveillance, Epidemiology, and End
Results Program
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company developing
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 its
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 evaluation of strategic alternatives, the
timetable for completing the evaluation of strategic alternatives,
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, Galena’s current and prospective financial condition,
liquidity and access to capital, 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, 2016, most recent Quarterly Reports on Form
10-Q, current reports on Form 8-K, and the prospectus supplement
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
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Apr 2024 to May 2024
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From May 2023 to May 2024