Galena Biopharma entered the oncology marketplace with its March 2013 acquisition of fentanyl (Abstral), a sublingual treatment for breakthrough cancer pain. Now the company is looking to expand its presence in the oncology field by developing and acquiring targeted cancer agents. Its pipeline includes an immunotherapy (NeuVax) that targets breast and prostate cancer, a folate binding protein (GALE-301) that targets endometrial and ovarian cancer, and a potential treatment for essential thrombocythemia (GALE-401).
Treatment with NeuVax (nelipepimut-S), which consists of the HER2-derived peptide E75 combined with granulocytemacrophage colony stimulating factor (GM-CSF), is intended to boost the immune system so that HER2-expressing cells are destroyed. The vaccine is aimed at preventing or delaying breast cancer recurrence in women with low levels of HER2 overexpression who would be considered HER2-negative (not eligible for trastuzumab) and are disease free after standard therapies that include surgery, chemotherapy, and radiation. After phase I/II trials indicated a lower rate of recurrence among women who received the vaccine, investigators launched the phase III PRESENT trial. Researchers are seeking to enroll 700 women.
In early January, Galena announced the enrollment of the first patient in its phase II ovarian cancer trial of GALE- 301, a folate-binding protein (FBP) immunotherapy. FBP is overexpressed in >90% of ovarian and endometrial cancers. It’s an ideal immunotherapy target for investigation because FBP has very limited tissue distribution and expression in nonmalignant tissue, according to Galena.
GALE-301 is administered with GM-CSF in the adjuvant setting to HLA-A2–positive patients. It is intended to prevent recurrence in ovarian and endometrial cancer patients who are disease free following standard therapy but are still considered high risk.
In the open-label phase II trial, HLA-A2–positive patients in two arms will receive GALE-301 plus adjuvant versus active control. Induction vaccinations will be administered monthly for 6 months, followed by two “boosts” given at 6-month intervals. Measuring immune response is the primary objective of the study, followed by the secondary measure of recurrence.
Previous phase I research established the optimal dose of GALE-301 and found that the treatment was well tolerated. Although the early-stage trial was not powered to assess efficacy, it was noted that GALE-301 triggered an FBP-specific immunological response. Galena reported that at a median of 6 months’ posttreatment, there were two recurrences among patients receiving GALE-301 (13.3%; n = 15) compared with four recurrences in the control group (25%; n = 16).
Galena has also added anagrelide CR (GALE-401) to its pipeline through its recent acquisition of Mills Pharmaceuticals. Immediate-release (IR) anagrelide is FDAapproved to treat essential thrombocythemia (ET); however, it has not been well tolerated by patients. GALE-401 is a controlled-release formulation of anagrelide that is expected to reduce the toxicity but maintain the efficacy of the IR version. Galena intends to launch a phase II study of GALE- 401 in mid-2014.