Galena Biopharma Engages Canaccord Genuity to Advise on Strategic Alternatives
March 09 2017 - 7:05AM
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
developing hematology and oncology therapeutics that address unmet
medical needs, today announced it has engaged Canaccord Genuity,
Inc. as its financial advisor to assist in the previously announced
strategic alternative review process.
Potential strategic alternatives may include a sale of the
company, a business combination, a merger or reverse merger with
another party, continuing to advance the clinical programs as a
stand-alone entity, and a license or other disposition of corporate
assets of the Company. The Company stated that there can be
no assurance that this strategic review process will result in a
transaction. Galena has not set a timetable for completion of
the review process, and it does not intend to comment further
regarding the strategic review process unless a specific
transaction is approved by its Board of Directors and signed, the
strategic review process is concluded, or it is otherwise
determined that further disclosure is appropriate or required by
law.
Galena’s clinical assets include:
- A hematology asset, GALE-401, which is a controlled-release
formulation of the approved drug anagrelide- Phase 3-ready program
with an FDA confirmed 505(b)2 regulatory pathway in essential
thrombocythemia
- An immuno-oncology franchise targeting prevention of recurrence
in breast and ovarian cancer with limited competition in each
indication- NeuVax™ (nelipepimut-S) - Three Phase 2, co-funded
investigator sponsored trials ongoing in adjuvant breast
cancer - Phase 2b, 300 patient trial expected to
complete enrollment in Q2 2017, and interim efficacy readout in Q4
2017- GALE-301 & GALE-302 - Early stage trials completed
targeting ovarian cancer
On March 15, 2017, Galena will issue its financial results for
the fourth quarter and year-end 2016.
About GALE-401 (Anagrelide Controlled
Release)
GALE-401 is a controlled release formulation of anagrelide
(Anagrelide CR) currently in clinical development for essential
thrombocythemia. The currently available immediate release
formulation (Agrylin® or anagrelide IR) is approved by the FDA for
the treatment of patients with thrombocythemia, secondary to
myeloproliferative disorders, to reduce the elevated platelet count
and the risk of thrombosis and to ameliorate associated symptoms
including thrombo-hemorrhagic events. Adverse events associated
with anagrelide IR, such as nausea, diarrhea, abdominal pain,
palpitations, tachycardia, and headache, may be dose and plasma
concentration dependent. GALE-401 is a reformulated,
controlled release version of anagrelide that reduces the maximum
plasma concentration (Cmax) of the drug and is expected to reduce
side effects, but preserve efficacy. A Phase 2 study with GALE-401
has been completed.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed
cancer immunotherapy under evaluation to prevent breast cancer
recurrence after standard of care treatment in the adjuvant
setting. It is the immunodominant peptide derived from the
extracellular domain of the HER2 protein, a well-established target
for therapeutic intervention in breast carcinoma. The nelipepimut-S
sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs)
following binding to specific HLA molecules on antigen presenting
cells (APC). These activated specific CTLs recognize, neutralize
and destroy, through cell lysis, HER2 expressing cancer cells,
including occult cancer cells and micrometastatic foci. The
nelipepimut-S immune response can also generate CTLs to other
immunogenic peptides through inter- and intra-antigenic epitope
spreading. In clinical studies, NeuVax is combined with
recombinant granulocyte macrophage-colony stimulating factor
(GM-CSF).
NeuVax is currently in two breast cancer studies in combination
with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in
node positive and triple negative HER2 IHC 1+/2+
(clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial
in high risk, node positive or negative HER2 IHC 3+ patients
(clinicaltrials.gov identifier: NCT02297698). A Phase 2
clinical trial is also ongoing with NeuVax in patients with ductal
carcinoma in situ (DCIS) (clinicaltrials.gov identifier:
NCT02636582), and a Phase 2 trial is planned in patients with
gastric cancer.
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
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
clinical trials have been completed with the FBP peptides: GALE-301
Phase 1/2a in ovarian and endometrial adenocarcinomas, and GALE-301
plus GALE-302 Phase 1b clinical trial in breast and ovarian
cancers.
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 process to seek an acquisition, merger,
strategic partnership or other strategic transaction and the
ability to maximize shareholder value through such a process, the
ability to identify and consummate any strategic transaction
through the process being commenced by the Company, 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, whether the company’s cash resources will be sufficient to
fund its continuing operations for the period anticipated, 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, 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
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