SAN RAMON, Calif., July 12, 2017 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs, today announced an update on the status of the Company and its most advanced clinical development program.
Galena’s primary focus is the evaluation of strategic alternatives initiated in the first quarter of this year. With the support of Canaccord Genuity, Galena has had extensive interactions with numerous companies to explore options for monetizing some or all of its clinical development programs through a license or sale of the assets, and/or transforming the Company via a sale, merger, reverse merger, or business combination with another company. While Galena is working through its strategic alternatives process, management has significantly reduced the staffing levels and certain operational expenses to preserve cash, although work remains ongoing to advance its two core clinical programs, GALE-401 and NeuVax™ (nelipepimut-S), and maintain their value.
For NeuVax, Galena continues to support the ongoing investigator sponsored studies, and today provided an update on the Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ patients in combination with trastuzumab. According to the latest report from the clinical research organization (CRO) conducting the trial, the study is nearly fully enrolled with 293 of the 300 patients enrolled to date. At the current pace, the CRO expects enrollment of the final 7 patients over the next few weeks with the interim analysis performed by the Data Safety Monitoring Board to occur six months after the final patient is enrolled.
Separately, Galena filed an S-1 registration statement (post effective amendment to S-3 on Form S-1) today to address our current S-3 ineligibility. The purpose of the S-1 registration statement, as filed, is to register currently outstanding warrants as we had notified warrant holders that we would update the ineffective S-3 through such a filing. All of the warrants are out of the money.
“While I am relatively new to Galena, I understand the road many of our shareholders have traveled in their investment with the Company, and I am very focused on seeking the best possible outcome from our strategic process that will maximize the opportunity for a financial return,” stated Stephen F. Ghiglieri, Interim Chief Executive Officer and Chief Financial Officer. “Given the challenges that Galena has faced, we are diligently addressing all aspects of our business and proactively removing potential impediments to executing a transaction. Reducing our expenses and simplifying our capital structure is paramount for us as we work to successfully complete the strategic alternative process. To that end, I want to thank our shareholders for the ratification vote we received on July 6, 2017, as it helps to clarify the capital structure of the Company and should enable us to complete our strategic alternatives process.”
Mr. Ghiglieri continued, “Thus far, we have had initial interest in potential transactions from a number of companies. Though this process is still evolving, we are committed to updating the market as key events unfold. My goal is to find the best available option, or options, for the Company and our assets to bring value to our shareholders. We appreciate the patience and continued support from our shareholders during this period.”
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 screening patients 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 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. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.
1National Cancer Institute Surveillance, Epidemiology, and End Results Program
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 statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward looking nature identify forward-looking statements for purposes of the federal securities laws and otherwise. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. There are or will be important factors that could cause actual results to differ materially from those indicated in these statements. These forward-looking statements include, but are not limited to, statements about the potential outcome of voting on the proposals at our upcoming special meeting of stockholders, strategic alternatives process including the timeline, evaluation and completion of a potential outcome of the process, the progress of the development of Galena’s product candidates, patient enrollment in our clinical trials, the progress and timing of our development activities, Galena’s current and prospective financial condition, liquidity and access to capital, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, projected market opportunities for product candidates, future expectations, plans and prospects for the final agreements among the U.S. Attorney’s Office for the District of New Jersey (“USAO NJ”) and the Department of Justice (“DOJ”) and the Company, the settlement terms among USAO NJ, DOJ and the Company, the settlement of any claims that might be made by state agencies in the future, the settlement terms with federal agencies such as U.S. Department of Defense, the Office of Personnel Management, the Office of Inspector General for the U.S. Department of Health and Human Services, defense costs and potential settlements of shareholder and derivative litigation, and other future events 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, 2016, 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.