Galena Biopharma (NASDAQ: GALE) is focused on developing and commercializing targeted oncology treatments to address major unmet medical needs and advance cancer care. The company’s peptide vaccine immunotherapies harness the patient’s own immune system to identify and destroy cancer cells. Utilizing peptide immunogens has many clinical advantages, including an excellent safety profile and long-lasting protection through immune system activation and convenient delivery.
GALE’s lead product, NeuVax, is currently enrolling a pivotal Phase 3 trial under a Special Protocol Assessment (SPA) from the FDA. In completed Phase 1/2 trials of NeuVax™, patients who exhibit robust in vitro immunologic response have lower recurrence rates. NeuVax companion diagnostic, the Leica Bond Oracle HER2 IHC assay, improves the accuracy of HER2 protein expression levels and patient targeting.
The company’s second product candidate, Folate Binding Protein (FBP), is a highly immunogenic peptide that can stimulate the immune system to recognize and destroy preclinical FBP-expressing cancer cells. The FBP peptide immunotherapy demonstrates excellent safety, robust immunologic responses, and preliminary efficacy in ovarian and endometrial patients in ongoing Phase 1/2a study.
Abstral® is GALE’s FDA-approved therapy for breakthrough cancer pain in opioid-tolerant cancer patients.
The company is actively seeking commercialization partners for its current clinical programs in selected regions of the world and welcomes ideas and proposals for strategic alliances, including in-licensing opportunities for commercial and late stage oncology products.
View the Company Website or Corporate Presentation.
Key Investment Highlights
- FDA-Approved Product to Treat Breakthrough Cancer Pain
Phase 3 PRESENT trial ongoing under FDA-approved SPA
Pipeline of Targeted Immunotherapies Addressing Major Markets
Strong Analyst Support with Median Price Target of $5.50
Therapeutic Cancer Vaccine Market is Doubling in Size Each Year
It is estimated that at least 40% of cancer patients experience breakthrough pain episodes multiple times per day, each with a median duration of 30 minutes. Abstral® is GALE’s FDA-approved therapy for breakthrough cancer pain in opioid-tolerant cancer patients. Abstral is the first and only fentanyl sublingual tablet for the pain management in this context. The innovative Abstral formulation dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes, and matches the duration of the entire pain episode.
GALE has identified its commercialization management team toward a launch in the fourth quarter of 2013. The company expects to market Abstral with 30 sales representatives and anticipates $1.5-$3.0 million in revenues in 2013, $8-$12 million in 2014, and peak sales of $40-$60 million in 3-5 years assuming a 10%-15% market share.
NeuVax is currently undergoing Phase 3 clinical trial for the adjuvant (after-surgery) treatment of early-stage HER2/neu-expressing breast and prostate cancer. Each year, approximately 230,000 people in the U.S. are diagnosed with breast cancer.
NeuVax has been developed to bolster the immune response in breast cancer patients. The trial, entitled PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) is being conducted under an FDA-approved Special Protocol Assessment (SPA). The therapy targets the 50% to 60% of patients with tumors that express HER2 in low-to-intermediate amounts and achieve remission with current standard of care, but who have no available HER2 targeted adjuvant treatment options to maintain their disease-free status. NeuVax can be used to help the body target and kill undetected cancer cells before they grow into metastatic tumors.
NeuVax may also be developed to treat other types of solid tumors.
Folate Binding Protein-E39 (FBP)
The company’s second product candidate, Folate Binding Protein (FBP), is a highly immunogenic peptide that can stimulate the immune system to recognize and destroy preclinical FBP-expressing cancer cells. FBP is over-expressed in more than 90% of ovarian and endometrial cancers, as well as 20%-50% of breast, lung, colorectal, and renal cell carcinomas. This vaccine is currently in a Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas.
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% that of breast cancer, the number of patients that die from ovarian cancer is nearly 50% 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 are routinely surgically debulked to minimal residual disease, and then treated with platinum-basd and/or taxane-based chemotherapy. While most patients respond to this treatment regime 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 over 46,000 women, with over 8,000 deaths, in the U.S. annually. There are two basic types of endometrial cancer: endometriod 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.
Each year, nearly 1.6 million new cases of cancer are diagnosed in the United States, excluding skin cancer diagnosed annually. Cancer is the second leading cause of death (after heart disease) in the United States, expected to account for about 572 thousand deaths. There are more than 100 different varieties of cancer, which can be divided into six major categories.
This year, one in four deaths in the US is expected to be due to cancer. For all forms of cancer combined, the 5-year relative survival rate is 64%. Despite the fact that the cancer mortality rate in the U.S. has risen steadily for the past 50 years, scientific advances appear to have begun to turn the tide. According to the National Center for Health Statistics, 2003 was the first year since 1930 annual cancer deaths declined - the start of what researchers hope will be a long-term decline in cancer mortality.
A cancer vaccine (cancer immunotherapy) is designed to target and therapeutically fight cancer cells. The vaccine could contain cells, parts of cells or pure antigens. There is also broad variability of potential vectors for delivering the “vaccine.” The goal of the vaccine is to increase the immune response against cancer cells that are already present in the body. Cancer immunotherapy is considered active immunotherapy because substances injected into the body are meant to trigger the patient’s immune system to respond.
Immunotherapy is a form of therapy that uses the patient’s own immune system to fight disease. This type of treatment works in two ways: education and stimulation of the immune system to work smarter, or the introduction of additional immune system components that help the immune system work more effectively. The first is generally known as active immunotherapy and the latter is generally known as passive immunotherapy.
NeuVax works by turning on the immune system. NeuVax recruits the main components of the cellular immune system to fight cancer by presentation of a T-cell peptide epitope in the context of the peptide-HLA-T-cell receptor complex. When NeuVax is administered, the E75 peptide, a well-established T-cell epitope discovered on HER2, binds to the HLA-A2 and HLA-A3 molecules on the surface of tumor cells and Antigen Presenting Cells (APCs). The peptide sends a signal to the immune system by binding in the HLA-peptide-T-cell receptor complex. Circulating T-cells recognize the peptide bound to HLA though T-cell receptors (TCRs) on their surfaces and the T-cells become “educated” and “activated” to target HER2-expressing tumor cells exhibiting the E75 epitope bound to HLA. Furthermore, activation of these T-cells leads to clonal expansion and proliferation of E75-specific “killer T-cells” that circulate through the body, identify and destroy cancer cells that are processing HER2.
Tumor cells are differentiated from healthy cells by the expression of tumor-associated proteins, also known as “tumor antigens.” HER2/neu is a well-established tumor-associated antigen found at various expression levels on the membrane surface of many types of human cancer cells. The human immune system is constantly surveying the body for foreign invaders (foreign proteins) or abnormal self proteins. To aid in this immune surveillance, cellular proteins such as HER2/neu and others are routinely digested or broken down inside the cell into short fragments called peptides and the small peptides are then “displayed” on the cell surface as a means of communicating with the immune system. Differences between the pool of peptides from a tumor cell and a normal cell are revealed on the outside of the cell. Peptides that are presented on or from tumor cells, but that are absent (or present to a far lesser extent) on healthy cells are called tumor-associated peptides (TAPs).
Unlike existing monoclonal antibody therapy which requires frequent, ongoing, intravenous (I.V.) infusion, NeuVax can produce continuing activation of the immune system and therapeutic levels of Killer T-cells with a once monthly intradermal (under the skin) dosing schedule that is less expensive and more convenient for both the patient and physician.
GALE is anticipating a handful of significant milestones throughout the next three years, including:
- Fourth quarter 2013 – Commercial launch of Abstral
Fourth quarter 2013 – Initial results from Phase I/2 for FBP Vaccine
Year-end 2013 – Complete enrollment in NeuVax Phase 3 PRESENT trial
First half 2014 – Interim analysis (70 events) for NeuVax Phase 3 PRESENT trial
Q4 2016/Q1 2017 - Results from NeuVax Phase 3 PRESENT trial
GALE is flying on the radar of the investment community and has garnered coverage by several reputable analyst firms, including Aegis Capital Corp., Cantor Fitzgerald, Piper Jaffray, and MLV & Co. Here is what some of the firms have to say:
JMP Securities has a “Market Outperform” rating on GALE stock with a price target of $5, stating, “We believe that a clear scientific rationale, well-established therapeutic target, and encouraging Phase 2 results are supportive of a favorable probability of success in the ongoing Phase 3 trial. Additionally, we see upside from the expected 4Q13 launch of Abstral, an approved rapid-onset, sublingual fentanyl tablet in the established cancer breakthrough pain market.”
Roth Capital Partners have issued a “Buy” rating on the stock with price target of $7, highlighting GALE’s opportunity for collaboration: “We see two potential synergies for Abstral with Galena's drug development efforts: 1) it should allow for earlier detailing of physicians (especially those who treat breast cancer) in order to build relationships for NeuVax' anticipated success and 2) projected revenues could help to manage the company's burn rate effectively.”
Analysts at Needham & Company have rated GALE at “Buy” with a price target of $3.50, stating that “We believe adjuvant vaccine therapy will ultimately become standard of care for many cancer types, and we view NeuVax as one of the leading new product candidates for this revolutionary treatment modality.”
Equity Research analysts have covered GALE with a “Buy” rating and a price target of $6. Noting early data from GALE’s FBP-Vaccine trials, which demonstrated at 59.3% reduction in disease recurrence among the first 20 enrolled patients, Equity Research says, “We view these preliminary results as very encouraging that the vaccine will continue to progress in clinical development, and will be likely to show a trend toward efficacy. At this point, these data present an upside to our Galena projections, but we consider these positive preliminary results as validation of the Galena vaccine approach.”
GALE’s highly experienced management team has an excellent track record in clinical development, commercial operations, and successful partnership execution. Enhanced by multiple development and commercial collaborations, the company’s suite of immunotherapeutic solutions is poised to capitalize on the vast opportunities in today’s healthcare industry.
Mark W. Schwartz - President and CEO
Mark W. Schwartz, Ph.D., joins Galena Biopharma after serving as executive vice president and chief operating officer of RXi Pharmaceuticals. He joined RXi as part of the Apthera acquisition where he had been the president and CEO of Apthera, Inc. Prior to joining Apthera, Dr. Schwartz served for five years as president and CEO of Bayhill Therapeutics, a company developing an innovative DNA vaccine platform for the treatment of autoimmune diseases where he complete a successful partnership with Genentech for the development of the company’s type 1 diabetes vaccine. He had also served as president and CEO of Calyx Therapeutics, which doubled its size, nurtured a successful working relationship with the Food & Drug Administration (FDA), and completed key phase I and phase II international clinical trials of novel anti-inflammatory compounds during his tenure.
Rosemary Mazanet - Executive Vice President & Chief Medical Officer
Rosemary Mazanet, M.D., Ph.D., is a life sciences investment professional and executive with management and drug development experience. She is a partner at Apelles Investment Management, LLC, and the president of Rosemary Mazanet LLC, a private consulting firm in the life sciences. Prior to that, Dr. Mazanet was a general partner, director of Research, and CSO of Oracle Partners, LP, a $1B health care hedge fund. Dr. Mazanet led clinical oncology at Amgen, Inc. from 1993-1998, and has also served as the CEO of several life sciences companies including Breakthrough Therapeutics and has served as a Director for numerous public and private companies. Dr. Mazanet received her M.D. and Ph.D. from the University of Pennsylvania School of Medicine (where she is a Charter Member of the Penn Medicine Board of Trustees and Executive Committee for the Health System), and trained in Internal Medicine at the Brigham and Women’s Hospital and Oncology at the Dana Farber Cancer Institute, both in Boston.
Hana B. Moran - Vice President, Regulatory & Compliance
Hana B. Moran, Ph.D. has more than 25 years of pharmaceutical industry experience in research, regulatory affairs, and quality assurance in start-up and high growth companies including Sangstat, Scios, Athena, Intarcia, and Hana Biosciences. She led marketing approvals for nine pharmaceutical products, including drugs, biologics, medical devices and in vitro diagnostics globally, including oncology. Dr. Moran earned an MSc in Chemical Engineering from Slovak Technical University, Bratislava, Slovakia, and a Ph.D. in Organic Chemistry from the Weizmann Institute of Science, Rehovoth, Israel.
Lynn Sutton - Vice President, Clinical Operations
Lynn Sutton, RN, MN, NP, has more than 12 years of experience in clinical critical care. Sutton began her career in the Pharmaceutical Industry as a Global Project Manager in Cardiovascular Research at Schering Plough Pharmaceuticals, running the pivotal trial for the Imdur registration study. With nearly 20 years in the industry, Sutton has worked in large pharmaceuticals, biopharmaceuticals, the CRO environment, and as an independent consultant in conducting Clinical Research in roles that included CRA Manager, project manager, manager/director of Clinical Safety & Clinical Development, director Clinical Operations, vice president of Clinical Drug Development. More recently, Sutton was the vice president of Clinical Services at Allos Therapeutics prior to joining Galena in the role of vice president of Clinical Operations. Throughout her career she has been responsible for overseeing global programs across all phases of development, focusing primarily in oncology and orphan indications.
Christopher Lento - Vice President, Sales & Commercial Operations
Christopher S. Lento joined Galena as its vice president, Sales and Commercial Operations to launch Abstral. Lento has 20 years of experience in senior level positions managing the sales, business development and operations at major healthcare companies including Genentech BioOncology, Altos Solutions, Abraxis Bioscience (acquired by Celgene Corporation), and US Oncology Network.
Ryan Dunlap - Director, Controller & Principal Accounting Officer
Ryan Dunlap is a CPA with 15 years of experience in accounting and finance, including 11 years in public accounting at large national and regional firms with a focus on the technology and life science industries. Dunlap also served as the director of Accounting at Vestas Wind Systems A/S, a public company that manufactures wind turbines and constructs wind parks, and in the Corporate Audit department at Nike, Inc., planning and executing operational and financial audits and leading Sarbanes Oxley implementation and maintenance teams. Dunlap holds a B.S. in accounting from the University of Oregon, and serves as treasurer on the Executive Committee of the Oregon Bioscience Association.
Latest News!!! http://www.thestreet.com/story/13163605/1/3-biotech-stocks-under-10-to-trade-for-breakouts.html?puc=yahoo&cm_ven=YAHOO http://finance.yahoo.com/news/galena-biopharma-announces-publication-two-110500808.html http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=917860