Chordoma

BN-BRACHYURY

PHASE 2 

---

Our novel immunotherapy candidate, BN-Brachyury, utilizes a prime-boost vaccination regimen that has been optimized to include the gene for brachyury and other molecules known to increase immune activation. Brachyury is a transcription factor that is believed to play a prominent role in the metastasis and progression of tumors, and a key prognostic indicator of several common (e.g. colorectal, prostate, small cell lung, and triple negative breast cancer) and rare or orphan (e.g. chordoma, thyroid, neuroendocrine) cancers. Expression of brachyury is highly correlated with metastatic disease, poor overall survival, multi-drug resistance, and decreased survival rates.

A Phase 2 clinical trial is ongoing in patients with advanced chordoma. The multi-site trial, which holds the potential to serve as a registration trial, aims to determine if the combination of BN-Brachyury and the current standard of care, radiation therapy, results in a clinically meaningful objective response rate (ORR) within 12 months of radiation therapy, a timeframe during which historical controls show an ORR of less than 5% with radiation alone. 

BN-Brachyury has received orphan drug status from the FDA in the treatment of chordoma.