Galena Biopharma Presents GALE-302 Preliminary Immunologic Data Optimizing GALE-301 at the Society for Immunotherapy of Cance...
November 09 2015 - 7:05AM
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
Company's GALE-301 and GALE-302 clinical programs were presented at
the Society for Immunotherapy of Cancer (SITC) 30th Anniversary
Annual Meeting in National Harbor, Maryland. The data presented was
on the primary vaccine series (PVS) from a randomized Phase 1b
trial with GALE-301 (E39) and GALE-302 (E39' – variant of E39;
previously named J65) that are folate binding protein-derived (FBP)
peptides.
Poster #166 (abstract #156) entitled, "Preliminary report of a
clinical trial supporting the sequential use of an attenuated E39
peptide (E39') to optimize the immunologic response to the FBP
(E39+GM-CSF) vaccine," details the results of a randomized trial
comparing three PVS sequences of E39 and E39' in ovarian and breast
cancer patients to optimize the ex vivo immune responses, local
reactions (LR), and delayed type hypersensitivity (DTH) reactions.
This preliminary analysis revealed both agents are immunogenic and
well tolerated with no differences in toxicities between PVS
sequences. The study demonstrates that the in vivo immune
response is enhanced with the use of the attenuated E39' (GALE-302)
after E39 (GALE-301). The optimal vaccination sequence
utilizing three inoculations of GALE-301 followed by three
inoculations of GALE-302 produced the most prominent and
statistically significant LR and DTH responses.
"We are pleased with the outcomes we observed in this trial as
we evaluate strategies to optimize the immune response from our two
clinical programs targeting folate binding protein," said Mark W.
Schwartz, President and Chief Executive Officer. "Folate
binding protein is a highly expressed tumor-associated antigen in
many cancers making it a very logical treatment target for active
immunotherapy. It also results in immunogenic peptides that have
led to the development of a potentially very potent
vaccine. It is theorized that this potency could lead to
T-cell burn-out in patients over time, so we are assessing whether
incorporating an attenuated version of the vaccine into the
treatment regimen will provide a better immune response. The
data derived from the DTH reactions indicate that treating patients
first with the strong vaccine followed by a weaker version may
provide a longer lasting effect. As the data continues to
mature we will consider the outcomes as we plan the next stages for
our GALE-301 and GALE-302 programs."
The Phase 1b is a single-center, randomized, single-blinded,
three-arm study in patients with breast (n=35) or ovarian cancer
(n=4) diagnosis who have been treated by standard of care and are
without evidence of disease. The primary endpoint of the trial is
immunologic and designed to determine which of the three PVS
strategies maximizes short and long-term specific immunity defined
as the number of E39-specific CTLs one and six months, respectively
following completion of the PVS.
"The data presented confirms our assumption that sequencing the
delivery of peptides provides varied immune responses and that the
delivery can be optimized to potentially provide improved patient
outcomes. Most importantly, we achieved a statistically significant
increase in LR and DTH when delivering E39 followed by E39' in the
PVS (p<0.001). We are currently implementing a booster program
and continued analysis of immunologic responses will further
elucidate the optimal vaccination series for the prevention of
recurrence in breast and ovarian cancer," commented Doreen O.
Jackson, M.D., post-doctoral fellow with the Cancer Vaccine
Development Program and the San Antonio Military Medical Center,
and the poster presenter.
HLA-A2-positive breast or ovarian cancer patients were enrolled
after completion of standard of care. The PVS includes six
inoculations, one every 3-4 weeks containing 250mcg GM-CSF plus
500mcg peptide in the first five patients per arm and 250mcg GM-CSF
+ 1000mcg of peptide in the second five patients. Thirty-nine
patients were randomized into three arms with 30 patients
completing the PVS:
- E39 (GALE-301) x 6 inoculations (n=12)
- E39 (GALE-301) x 3 inoculations followed by E39' (GALE-302) x 3
inoculations (n=14)
- E39' (GALE-302) x 3 inoculations followed by E39 (GALE-301) x 3
inoculations (n=13)
Ex vivo immune response was measured via dextramer assay for
E39-specific CD8+ T-cells at pre-vaccine (R0), then 1 and 6-months
after the PVS (RC1, RC6). To assess the in vivo immune
response, LR was measured 48 hours after each inoculation, and DTH
reactions were measured at R0, RC1, and RC6. Statistical analyses
included descriptive statistics, 2-tailed t-test, Chi-squared,
Fisher's exact test and ANOVA as appropriate.
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 in gynecological
cancers: 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 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 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 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
(925) 498-7709
rbernarda@galenabiopharma.com
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