Presentation provides immunologic and
booster data on GALE-301/GALE-302
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 data from Galena’s GALE-301/GALE-302 clinical
program was presented at the Society for Immunotherapy of Cancer
Conference 2016 in National Harbor, Maryland. 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 showed no evidence of disease at enrollment. This trial
augments the Phase 1/2a trial with single-agent GALE-301 in ovarian
and endometrial cancers.
Previous trials have demonstrated that although boosting
vaccinations help to maintain long-lasting immunity, attenuated
peptides may be a better choice for boosting because
over-stimulation with an immunogenic peptide may lead to cytotoxic
T lymphocyte (CTL) exhaustion and death. This phenomenon is known
as antigen-induced cell death. The presentation, entitled, “Phase
Ib Trial of Two Folate Binding Protein (FBP) Peptide Booster
Vaccines (E39 and E39') in Breast and Ovarian Cancer Patients,”
reported the peptide-specific immune response to E39 and E39' after
different combinations of vaccination and boosting.
Both E39 and E39' are well tolerated with all related adverse
events at grade 1 or grade 2. Though numbers were small, patients
boosted with the attenuated peptide showed increased CTL response
to boosting regardless of significant residual immunity (SRI)
resulting from the primary vaccination series (PVS). While this
data needs to be confirmed with a larger sample size, this is
consistent with the theoretical advantage of boosting with an
attenuated peptide, which is expected to induce less
antigen-induced cell death of CTLs.
“This data set on our FBP-targeted agents GALE-301 and GALE-302
provides critical information to understand how different booster
regimens may impact the outcome for patients,” said Bijan Nejadnik,
M.D., Executive Vice President and Chief Medical Officer. “Cancers
are different in their level of over-expression of FBP. High
expressors, such as ovarian cancer, are more likely to develop
tolerance and may need a higher dosage or more antigen stimulation
with a stronger vaccine such as GALE-301 to overcome the tolerance
and be effective. On the other hand, ninety percent of patients
enrolled In this Phase 1/2a trial were breast cancer patients with
lower FBP expression who have less tolerance and may benefit from a
more attenuated antigen such as GALE-302, or alternatively from a
lower dosage of the immunodominant antigen vaccine such as
GALE-301. This will lead to the desired balance with maximum
effect, while preventing CTL exhaustion and antigen induced CTL
death. We expect the final data set from this trial to be
presented next year.”
Ex-vivo immunologic recognition of E39 was assessed by clonal
expansion of CTLs and in-vivo response by delayed-type
hypersensitivity (DTH). Immunologic data was gathered at 1- and
6-months post-booster and was then analyzed. The 6-month post-PVS
immunologic data was used to assess patients for SRI, defined as
≥2-fold increase from pre-PVS in E39-specific CD8+T-cells. Patients
were sorted into two groups: those with SRI (SRI) and without
(nSRI). Patients within each group were randomized to one booster
of either E39’ or E39 resulting in four groups:
- SRI receiving E39 (SRI-E39)
- SRI receiving E39' (SRI-E39')
- nSRI receiving E39 (nSRI-E39)
- nSRI receiving E39' (nSRI-E39')
Sixteen patients were found to have SRI and 12 had nSRI; these
patients were randomized to booster arms (SRI-E39:n=9;
SRI-E39':n=7; nSRI-E39:n=7; nSRI-E39':n=5). There were no
clinicopathologic differences between groups. When comparing
DTH pre-booster and at 1- and 6- months post-booster there were no
significant differences between SRI vs nSRI (p=0.350, p=0.276,
p=0.133, respectively), E39 vs. E39' (p=0.270, p=0.329, p=0.228),
nor between all four groups (p=0.394, p=0.555, p=0.191). Comparing
the change in CTL’s from pre- and 6-months post-booster, regardless
of SRI, patients boosted with E39’ had increased CTL (+0.02) while
those boosted with E39 had decreased CTL (-0.07, p=0.077). There
was no difference comparing the change in DTH between groups
(p=0.927).
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).
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)
The poster presentation from the conference will be available on
Galena’s website here.
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 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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