NeuVax

Vaccine: NeuVax (nelipepimut-S)
Company: Galena Biopharma
Target: Breast cancer

About 75% of breast cancers test positive for HER2 (human epidermal growth factor receptor 2) to some degree, but only 25% of breast cancers produce a high enough staining signal under the microscope to be eligible for treatment with Genentech's Herceptin (trastuzumab). Galena Biopharma ($GALE) has developed NeuVax (nelipepimut-S) for the 50% of patients with tumors that stain low or intermediate for HER2 and so would not receive trastuzumab after surgery, adjuvant chemotherapy and radiation.

NeuVax combines a fragment of HER2 along with granulocyte macrophage colony-stimulating factor (GM-CSF), which boosts the immune response. It's given as an intradermal injection, between the layers of the skin, once a month for 6 months, followed by a booster injection once every 6 months.

NeuVax has been studied in a range of clinical trials, including the ongoing Phase III trial, PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment). A number of patients are now at 60 months (5 years) follow-up, a point that some physicians regard as a cure. After 24 months, 91% of NeuVax patients were disease-free compared with 80% in the control group. After 60 months, 85% of NeuVax patients were disease-free, compared with 77% in the control group.

The 60-month follow-up also showed that the rate of breast cancer recurrence was greatly reduced for the patients treated with NeuVax, and that adding a booster dose increased the immune response and maintained the durability of the clinical benefit.

In November 2011, Galena signed an agreement with Genentech, part of the Roche ($RHHBY) Group, to combine NeuVax with trastuzumab in adjuvant breast cancer patients not eligible for trastuzumab therapy. The two companies will sponsor a Phase II study in about 300 patients.