Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of hematology
and oncology therapeutics that address unmet medical needs, today
announced that Dr. Doreen Jackson delivered a podium presentation
on Galena’s GALE-301 and GALE-302 clinical program at the American
College of Surgeons Clinical Congress 2016 in Washington,
D.C. GALE-301 (E39) and GALE-302 (E39’ – variant of E39) are
cancer immunotherapies that consist 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. The
Phase 1b is a single-center, randomized, single-blinded, three-arm
study in patients with breast or ovarian cancer diagnosis who were
treated with standard of care and were without evidence of disease.
This trial augments the Phase 1/2a trial with single-agent GALE-301
in ovarian and endometrial cancers.
The presentation is entitled, “A Phase Ib Trial
Comparing Different Doses/Schedules of a Folate Binding Protein
(FBP)-derived Peptide Vaccine, E39, and its Attenuated Version,
E39’, to Induce Long-term FBP-specific Immunity in Disease-free
Cancer Patients.” In this trial, which enrolled mostly breast
cancer patients, who have lower FBP exposure than ovarian patients,
the 500mcg dose appears to provide a more optimal immunological
response. This differs from the results in ovarian cancer
patients, who have much higher FBP expression, with potential
secondary immune tolerance, where 1000mcg was the optimal dose.
However, E39’ (GALE-302) given after E39 (GALE-301) was able to
induce long-term immunity in both dosing cohorts, underscoring the
potential importance of attenuated peptides in relatively
antigen-naïve patients.
In the patients who received 500mcg of peptide
(n=14), delayed-type hypersensitivity (DTH), but not E39-specific
cytotoxic T-lymphocytes (CTLs), increased at 1- and 6-months
post-primary vaccine series (PVS)(p=0.03 for both). No
differences were seen in the patients (n=16) who received 1000mcg
of peptide. Comparing the 3 arms in patients who received 500
mcg dosing, only the patients who received E39 followed by E39’
showed increased DTH at 1-month (p=0.013) and 6-months
(p<0.0001). In the patients with this same schedule who
received 1000mcg of peptide, at 6-months they saw increased DTH
(p=0.02) and CTLs (p=0.046). There were no clinicopathologic
differences or toxicities greater than grade 2 seen in any of the
doses or schedules.
“Similar to the FBP expression levels presented
earlier this month from the GALE-301 clinical trial, this
GALE-301/GALE-302 data on dosing and treatment schedules is
extremely valuable as it highlights the potential utility of the
vaccine in different cancer indications as we plan the next path
forward for our clinical program targeting FBP,” said Bijan
Nejadnik, M.D., Executive Vice President and Chief Medical Officer.
“This data adds to the body of science for the vaccine and is
instrumental in understanding the interaction of our peptides in
the treatment landscape. Importantly, the immunologically active
doses of the vaccine targeting FBP seem to vary between the breast
and ovarian patient populations, and may reflect the implication of
the level of FBP expression on the cells. We may consider the use
of an attenuated version of this peptide in patient populations
with lower FBP expression, since the potency of the FBP vaccine
could lead to T-cell burn-out in patients over time.”
Dr. Nejadnik continued, “We would like to
congratulate Dr. Jackson who was given an award for ‘Excellence in
Research’ by the American College of Surgeons for her work on this
program. And, we look forward to her poster presentation in
December at the San Antonio Breast Cancer Symposium where she will
be providing additional data from this trial in breast cancer
patients.”
HLA-A2-positive breast or ovarian cancer patients
were enrolled after completion of standard of care and without
evidence of disease, regardless of FBP expression level. The PVS
includes six inoculations, one every 3-4 weeks containing 250mcg
GM-CSF plus 500mcg peptide in the first five patients per arm
(n=14) and 250mcg GM-CSF + 1000mcg of peptide in the second five
patients (n=16). Delayed-type hypersensitivity (DTH) and
E39-specific CTLs were assessed at one and six months post-PVS.
Thirty-nine patients were randomized into three arms with 30 breast
(n=27) or ovarian (n=3) cancer patients completing the PVS and
assessed for this presentation:
- E39 (GALE-301) x 6 inoculations (n=10)
- E39 (GALE-301) x 3 inoculations followed by E39’ (GALE-302) x 3
inoculations (n=10)
- E39’ (GALE-302) x 3 inoculations followed by E39 (GALE-301) x 3
inoculations (n=10)
About GALE-301 and GALE-302
GALE-301 and GALE-302 are cancer immunotherapies
that consist 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. GALE-301 is the E39 peptide, while
GALE-302 is an attenuated version of this peptide, known as
E39’. FBP is a well-validated therapeutic target that is
highly over-expressed in ovarian, endometrial and breast cancers,
and is the source of immunogenic peptides that can stimulate
cytotoxic T lymphocytes (CTLs) to recognize and destroy
FBP-expressing cancer cells. Two trials are ongoing with FBP
peptides: the GALE-301 Phase 2a portion of the Phase 1/2a clinical
trial is ongoing in ovarian and endometrial adenocarcinomas
(ClinicalTrials.gov Identifier: NCT01580696); the GALE-301 plus
GALE-302 Phase 1b clinical trial is ongoing in breast and ovarian
cancers (ClinicalTrials.gov Identifier: NCT02019524).
About Breast Cancer1
New cases of breast cancer occur at an annual rate
of 125 per 100,000 women in the U.S., with an estimated 246,660 new
cases and 40,450 deaths in 2016. Approximately 89.7% of breast
cancer patients are expected to survive five years after diagnosis.
Approximately 12.4% of women will be diagnosed with breast cancer
at some point during their lifetime (2011 – 2013 data). The
prevalence data from 2013 showed an estimated 3,053,450 women
living with breast cancer in the United States.
About Ovarian Cancer1
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.
1National Cancer Institute Surveillance, Epidemiology, and End
Results Program
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 GALE-301 and GALE-302,
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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