Could This Breast Cancer Vaccine Be a Game Changer?

Breast cancer claims more than 40,000 lives in the United States annually and is one of the leading causes of death for females globally. However, every year biotech companies are making incredible advances in breast cancer treatments that could eventually eradicate this debilitating disease.

A breast cancer vaccine
One of the most promising new treatments is Galena Biopharma's (NASDAQ: GALE  ) NeuVax, a breast cancer vaccine that attempts to stop recurrences of node-positive HER2-negative breast cancer. NeuVax works by stimulating the patient's immune system to seek out and destroy residual cancer cells expressing the HER2/neu protein in patients who have achieved remission. The HER2/neu protein is often associated with colon, breast, ovarian, pancreatic, and bladder cancers.

HER2-negative breast cancer accounts for approximately 75% of all breast cancer cases. There is a 15% to 20% chance of breast cancer recurring, even following a mastectomy, which means that NeuVax could be a game-changing blockbuster treatment if approved. In phase 2 trials, patients dosed with the treatment showed a 5.6% recurrence rate compared to a 25.9% recurrence rate in the control arm -- a 78.4% reduction in total recurrences. 

Two major supporters
NeuVax is currently in a phase 3 trial for the stand-alone usage as a breast cancer vaccine, and in a phase 2 trial for combined use with Roche's (NASDAQOTH: RHHBY  ) Herceptin. Herceptin is one of the primary approved treatments for HER2 breast cancer, which generated $6 billion in sales last year.

Herceptin is a monoclonal antibody that attaches itself to the surface of a cancer cell to prevent it from receiving new growth signals. It can also alert the immune system to destroy the cancer cells to which it is attached. Therefore, using NeuVax's ability to stimulate the immune system to actively seek out the cancer with Herceptin's ability to starve and mark cancer cells could prove to be an incredibly potent combination. For Roche, creating a new combined treatment could also soften the blow of Herceptin's upcoming patent expiration in 2014.

In addition to Roche, another major company that believes in Galena is Teva Pharmaceuticals (NYSE: TEVA  ) . Last December, Galena signed an agreement with Teva to commercialize NeuVax in Israel. Teva will provide marketing support and help NeuVax obtain regulatory approval in the region. Teva also produces a generic version of AstraZeneca's breast cancer drug Arimidex, which is used for post-surgery treatment.

Abstral provides a steady revenue stream
Galena also acquired the U.S. commercialization rights for Abstral, a cancer pain medication, from Orexo AB in March. Abstral was approved by the FDA in 2011 as the first and only fentanyl sublingual tablet to treat patients with breakthrough ("spiking") cancer pain in opioid tolerant patients, and generated $54 million in sales in Europe last year.

Bringing Abstral to the U.S. market will give the company a steady stream of revenue -- a strength that many other speculative biotechs sorely lack. Last quarter, Galena only had $26.7 million in cash and equivalents, with $9.7 million in debt and a negative cash flow of $21.8 million.

The Foolish bottom line
Shares of Galena have been fairly volatile, but have nonetheless risen 30% over the past 12 months. Although some investors have expressed doubt regarding NeuVax's potential success, it's tough to bet against this company, especially when it has major players like Roche and Teva in its corner.

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  • Report this Comment On August 23, 2013, at 2:29 PM, applesaucehead wrote:

    Good things are coming to shareholders who waited on Galena and stood strong through all the rhetoric and negative articles that created downside for a winning vaccine that could change the future for a lot of cancer patients.

  • Report this Comment On August 24, 2013, at 10:16 AM, jlong56 wrote:

    I sure hope you can make whole lot of this vaccine because there will be thousands of breast cancer patients in line for it!!!!! There are too many of us who go through the whole treatments regimens of surgery, toxic chemo, rounds of radiation then years of Tamoxifen or AIs --- only to have recurrence and many to Stage 4. Now with internet we all track the pharma and research news always HOPING this will be the year of a MAJOR break through..........

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