Brachyury is over-expressed in a variety of important tumor types including breast, colon, lung and prostate cancers.
The primary endpoint of open-label study is the safety and tolerability of escalating doses of GI-6301 given as a single agent.
The secondary endpoints of dose-cohort escalation trial include levels of brachyury-specific T cells, reduction in brachyury serum markers and circulating tumor cells and evidence of clinical benefit.
The GI-6301 Tarmogen was jointly developed by GlobeImmune and NCI under a collaborative research and development agreement (CRADA).
GlobeImmune president and CEO Timothy Rodell said the trial potentially expands the utility of their Tarmogen platform that has already shown promise in patients with tumors expressing CEA and mutated Ras.