Platform: Therapeutic vaccines
Company: Galena Biopharma ($GALE)
Therapeutic target: Oncology
Therapeutic vaccines have been a holy grail of biopharma. The 2010 approval of Dendreon's ($DNDN) Provenge for metastatic prostate cancer proved they are the real deal, even if the high cost of manufacturing them hurts profit margins. Last October, FierceBiotech presented a roundup of 10 such promising vaccine candidates that are being studied in humans for cancer and other indications, including immune diseases.
One recently announced therapeutic vaccine is for HER2-positive breast cancers. In January 2012, Oswego, OR-based Galena said it would begin pivotal clinical trials for NeuVax, which combines the E75 peptide with the HER2/neu protein and an immune system stimulant, granulocyte macrophage colony-stimulating factor (GM-CSF).
The vaccine, developed by the military, is designed to spur immune attacks on cancers that express the HER2 protein. Outcomes from earlier clinical trials were promising, showing the recurrence rate was cut in half.
Galena followed up that announcement in February by saying it has initiated enrollment in a Phase I/II study of its folate-binding protein (FBP) (E39) targeted vaccine in ovarian and endometrial adenocarcinomas.
Given the high rate of recurrence in these cancers, Galena expects it may see clinical efficacy data within two years. Ovarian cancer occurs in more than 22,000 women per year in the United States, and the majority will relapse. Endometrial cancers kill more than 8,000 women per year and affect more than 46,000 patients in the U.S. annually.