Bavarian Nordic Reports Preliminary Data from Phase 2 Trial of CV-301 in Metastatic Breast Cancer

KVISTGAARD, Denmark, October 1, 2012 - Bavarian Nordic A/S (OMX: BAVA) today announced preliminary results from a randomized, open-label, multi-center Phase 2 study of CV-301 (CEA/MUC-1/TRICOM), an immunotherapy product candidate, in combination with docetaxel versus docetaxel alone for the treatment of metastatic breast cancer. The data were presented at the ESMO 2012 Congress (European Society for Medical Oncology) in Vienna, Austria, by Christopher R. Heery, MD, and colleagues from the National Cancer Institute (NCI).

An abstract of the study is available online at:

A preliminary analysis of the study showed progression-free survival (PFS) of 6.6 months in the CV-301 group versus 3.8 months among those receiving docetaxel alone. The clear separation of the curves indicates potential benefit. Because of its size the study was not designed to reach statistical significance. Accordingly, the p-value of (p=0.12) is considered to be a successful outcome, even though it does not meet criteria for statistical significance.

"The results we have seen to date from this NCI sponsored Phase 2 study are encouraging and support exploring options for further clinical development of CV-301 in metastatic breast cancer," said Reiner Laus, MD, President of the Cancer Vaccine Division of Bavarian Nordic A/S. "We are excited by the growing body of clinical evidence which validates our immunotherapy platform for the treatment of cancer."

The Phase 2 study enrolled 48 patients with metastatic breast cancer to receive CV-301 in combination with docetaxel or docetaxel alone. Enrolment completed in February 2012 (CV-301, n=25; control, n=23) and 5 patients remained on study at the time of the analysis (2 in the CV-301 group, 3 in the control). The primary study endpoint was PFS, while secondary endpoints included overall survival and immunologic correlative studies. Demographics were well matched and toxicity was similar in both arms. Immune analysis and correlation to patient clinical outcomes is ongoing.

As previously announced, final study data are expected during fourth quarter 2012, whereupon Bavarian Nordic will determine its future development strategy for CV-301.