Galena Biopharma Presents GALE-301 Phase 1 Data at the American Society of Clinical Oncology (ASCO) 50th Annual Meeting
June 02 2014 - 7:05AM
- Phase 1 study demonstrates GALE-301
(Folate Binding Protein) cancer
immunotherapy is well tolerated and induces an immune response in
ovarian and endometrial cancer patients.
- Ongoing Phase 2a trials to establish preliminary
efficacy, as well as evaluate a longer-term booster regimen, to
complete enrollment this year.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer
care, today announced that data from the Company's Phase 1 study
with GALE-301, or Folate Binding Protein (FBP), was presented at
the American Society of Clinical Oncology (ASCO) 50th Annual
Meeting. The poster entitled, "Comparison of recurrent and
nonrecurrent ovarian and uterine cancer patients undergoing
adjuvant folate receptor vaccine therapy," was presented during the
Gynecologic Cancer General Poster Session.
Folate Receptor Alpha (FRα) (also known as FBP) is an
immunogenic protein that is over-expressed in breast, lung,
endometrial and ovarian cancers. FRα expression in malignant
cells is 20-80 fold higher compared to normal cells.
Galena conducted a Phase 1 dose escalation clinical
trial with E39, an HLA-A2 positive, FRα peptide combined with the
immune adjuvant, granulocyte macrophage-colony stimulating factor
(GM-CSF). The vaccine is administered in the adjuvant setting
to prevent recurrences in high-risk endometrial and ovarian cancer
patients rendered clinically disease-free after standard-of-care
therapy. The current analysis compared in vivo immunologic
responses (IR) and disease features between vaccinated
non-recurrent (vNR) and vaccinated recurrent (vR) patients.
Overall, 30 patients were enrolled in the Phase 1 trial. Of
14 control patients, 7 (50%) have recurred. Of 16 vaccinated
patients, 4 (25%) have recurred after completing the primary
vaccine series (PVS), 2 (12.5%) recurred prior to completing the
PVS, and one patient withdrew. Of note, no recurrences have
been seen in the optimal dose cohort of 1000 mcg E39. The vR
patients displayed lower mean delayed type hypersensitivity (DTH)
reactions as well as lower local reactions at every measured time
point.
"These promising initial results demonstrate the vaccine is dose
responsive with the immune system and we are encouraged about the
potential for this compound to prevent recurrence in women
suffering from high risk gynecological cancers where current
treatment options are limited," said Mark J. Ahn, Ph.D., President
and Chief Executive Officer. "The data from this study served
as the basis for advancing GALE-301 into its ongoing Phase 2 trial
that includes a booster regimen. We expect enrollment in this trial
to complete shortly, ahead of schedule."
In the Phase 1 study, HLA-A2 positive patients were enrolled
into the vaccine group and received intradermal inoculations of E39
+ 250 mcg GM-CSF once a month for six months (the PVS) following
assignment into a dose cohort: 100mcg, 500mcg, or 1000mcg of
E39. In vivo IR was assessed by both local reaction (LR) after
each inoculation and DTH reaction measured pre-vaccination and
post-PVS (DTH2).
Comparison between vNR and vR patients demonstrates recurrences
are likely related to trends in both disease features (age but not
stage) as well as diminished response to the vaccine as seen by LR
and DTH. As decreased vaccine response may be related to more
aggressive disease, the most viable way to address this observation
is to vaccinate in earlier stage disease. The ongoing Phase 2a
trial is attempting to establish a preliminary efficacy signal, as
well as evaluate a longer-term booster regimen.
"Folate binding protein is highly over-expressed in ovarian and
endometrial cancers and is a key target for vaccine-induced
immunity to prevent recurrence for women suffering from these
diseases. This preliminary trial has shown that the FBP
vaccine is well-tolerated and immunogenic, warranting the
additional ongoing phase 2a trials to demonstrate the efficacy of
the vaccine," concluded Dr. Erika J. Schneble, San Antonio Military
Medical Center, San Antonio, TX who presented the results.
About GALE-301 (Folate Binding Protein (FBP)
vaccine)
GALE-301 (Folate Binding Protein (FBP)) cancer immunotherapy
targets FBP, a well-validated therapeutic target, which is highly
over-expressed in breast, ovarian and endometrial cancers. FBP is
the source of immunogenic peptides that can stimulate cytotoxic T
lymphocytes (CTLs) to recognize and destroy presenting
FBP-expressing cancer cells. The FBP vaccine consists of the
FBP peptide(s) combined with the immune adjuvant, granulocyte
macrophage-colony stimulating factor (GM-CSF). Galena's
FBP vaccine is currently in Phase 2a trials in two gynecological
cancers: ovarian and endometrial adenocarcinomas.
About Ovarian/Endometrial Cancers
Ovarian cancer occurs in more than 22,000 patients per year in
the U.S. and is the most lethal gynecologic cancer. Despite the
incidence of ovarian cancer being only approximately 20% of that of
breast cancer, the number of patients that die from ovarian cancer
is nearly 50% of that of breast cancer. Due to the lack of specific
symptoms, the majority of ovarian cancer patients are diagnosed at
later stages of the 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
most patients respond to this treatment regimen and become
clinically free-of-disease, the majority of these patients will
relapse, and once the disease recurs, the treatment options and
successes drop dramatically.
Endometrial cancer is the most common gynecologic cancer and
occurs in more than 46,000 women with more than 8,000 deaths in the
U.S. annually. There are two basic types of endometrial cancer:
endometrioid and papillary serous. The latter has a much more
aggressive clinical course and the majority of these patients will
die of this form of the disease.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company developing and commercializing
innovative, targeted oncology treatments that address major unmet
medical needs to advance cancer care. 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 Abstral®
and development of Galena's product candidates, including patient
enrollment in our clinical trials, as well as statements about our
expectations, plans and prospects. 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, 2013 and
Quarterly Report on Form 10-Q for the quarter ended March 31, 2014
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.
CONTACT: Remy Bernarda
VP, Marketing & Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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