> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Orphan Status for Bavarian Nordic Cancer Vaccine
- URL: https://www.fdaweb.com/orphan-status-for-bavarian-nordic-cancer-vaccine/
- Published: 2018-05-02T12:00:00.000Z
- Updated: 2026-09-15T00:02:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141350

FDA has granted Bavarian Nordic an orphan drug designation for its BN-Brachyury vaccine for treating chordoma, a rare cancer that develops along the spine. A Phase 2 study in patients with metastatic chordoma will begin in the second half of this year, enrolling up to 25 patients. An open-label Phase 1 trial is currently underway to evaluate the safety and tolerability of the BN-Brachyury vaccine. The primary endpoint of the study is safety and tolerability, and secondary endpoints include immunologic responses, as measured by an increase in brachyury-specific T-cells and other tumor-associated antigens, the company says.