By Amy Baldwin
Galena Biopharma, Inc. (NASDAQ:GALE) is working on its breast cancer vaccine, NeuVax, which has entered into Phase III trials. If successful, this vaccine would not only help prevent millions of deaths caused by breast cancer, it would also delay the progression of damage caused by breast cancer. Below, I will examine Galena Biopharma (GALE) as an investment candidate in the context of the prevalence of breast cancer worldwide, the viability of vaccines in preventing and treating breast cancer, and discuss the company’s NeuVax vaccine and how it could be a long-term growth catalyst for its stock.
Prevalence of Breast Cancer Worldwide
Cancers are often deadly, but when detected early, some of them respond very well to treatment. Breast cancer caused 200,000 deaths worldwide in 2010 alone. Moreover, the number of new cases of breast cancer has risen from 640,000 in 1980 to more than 1.6 million in 2010, according to a report by the University of Washington. With such dreary statistics, vaccines seem to be a promising and effective way to prevent or delay the growth of cancerous tumors.
According to the Centers for Disease Control and Prevention (CDC), the most recent statistics available indicate that breast cancer is the most common type of cancer seen in women. In 2007, 202,964 women living in the U.S. were diagnosed with breast cancer. Of those diagnosed, 40,598 died from the disease. The CDC also noted that “screening tests and the HPV vaccine could help prevent some of the most common types of cancer in women.”
Vaccines Show Promise in Fighting Breast Cancer
When breast cancer cells are treated through chemotherapy, radiation, or surgery, some cells may remain unaffected. These surviving cells, according to the Mayo Clinic, may multiply later on, causing recurrent breast cancer. Worse yet, these surviving cells can proliferate and affect bone marrow, lung tissue, or the liver. One proposed way of helping to prevent such surviving breast cancer cells from replicating further is though an immunotherapy agent such as a cancer vaccine.
Dr. Rafael Lozano, professor at University of Washington’s Institute for Health Metrics and Evaluation, warned that breast cancer is no longer limited to affluent western countries, but affects developing and underdeveloped countries at an exponential level. The University of Cincinnati Cancer Institute and the National Institutes of Health conducted animal studies to test the efficacy of vaccines on cancerous tumors. The results were very promising. Oral breast cancer vaccines helped cancer patients to produce antibodies and T-cell responses that effectively killed tumors. While more research needs to be conducted in this area, vaccines appear to be an effective way to prevent and delay the progression of breast cancer.
Galena Biopharma’s NeuVax Phase 3 PRESENT (Prevention of Recurrence in Early-Stage Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study is currently evaluating the effectiveness of that vaccine in preventing breast cancer growth, and also in delaying the recurrence of breast cancer after standard of care treatment. The vaccine entails an intradermal injection once a month for a period of 6 months.
After six of these injections are administered, the volunteers will be given booster shots every 6 months for 30 months. The company is recruiting patients at the moment, and the therapies earlier studies appeared to be very promising. If this vaccine is commercialized, those eligible (having low to medium HER2 expressions) in the 1.6 million new cases could be effectively targeted with NeuVax. Considering how quickly breast cancer is increasing among developing and developed countries, the market for such a vaccine could be substantial.
Celgene Corporation’s (NASDAQ:CELG) breast cancer drug, Abraxane, has often been described as a “Swiss army knife” for cancer. This is because the drug not only treats breast cancer, but also non-small cell lung cancer and may soon get approval as a drug to treat pancreatic cancer. Abraxane certainly helped Celgene’s adjusted net income increase by 21% to $572 million in its 4th quarter results.
Verastem Inc. (NASDAQ:VSTM) is a company that has taken a different route to treating cancers. The company is working steadfastly to develop molecule inhibitors of signaling pathways that are critical to cancer stem cell (CSC) survival and proliferation. These cancer stem cells are thought to be behind the recurrent nature of many cancers as they are more like “normal” cells and resistant to chemotherapy and radiotherapy. After they survive the initial treatment regimen, they can then proliferate and produce more cancer cells. In July of 2012 the company acquired a cancer drug from Pfizer Inc. (NYSE:PFE) that had recently completed a 36 patient phase 1 trial for advanced solid tumors. With the rest of the company’s pipeline still in preclinical development, the new acquisition is now Verastem’s lead product candidate.
GlaxoSmithKline (NYSE:GSK) and Roche Holding Limited (PINK:RHHBY) have drugs which, when used in combination, can help prevent the spread of breast cancer to the brain. GlaxoSmithKline’s breast cancer drug, Tykerb, can be used along with Roche’s Xeloda to help prevent cancer from spreading to the brain. The drugs also reduce cognitive decline associated with brain radiotherapy, since the radiotherapy may be delayed or avoided all together.
Galena Biopharma’s NeuVax is a promising breast cancer vaccine. It could potentially prevent and delay the progression of breast cancer tumors. The demand for such a vaccine could be significant and could act as a long-term growth catalyst for the stock. Investors should watch Galena closely for any new developments surrounding its NeuVax trials. It is still a development phase company with the risks typical of such a company with elevated stock volatility and stock offerings always a possibility. However, the upside potential makes this an attractive investment as phase 3 interim data should be forthcoming very soon.
Roche, GlaxoSmithKline and Celgene are also good investments, but for a different type of investor as each of these has solid revenue with much less stock volatility. Although neither of these will likely experience significant upside with success in breast cancer treatments, the market potential for breast cancer is large enough to still provide substantial revenue and solid growth for the large pharmaceuticals moving forward.
At $212 million, Verastem’s market capitalization is almost double that of Galena’s, despite the company’s program being substantially less developed than Galena’s. In my opinion, Galena’s lower market capitalization and more advanced pipeline makes it a safer and better investment than Verastem, at least for those investors looking at the higher risk but potentially higher reward biotech investments.
Disclosure: Long Gale