SAN RAMON, Calif., March 09, 2017 (GLOBE NEWSWIRE) -- 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 (C max ) 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
