GlobeImmune, Inc. launched a Phase 1 clinical trial to be conducted at the National Cancer Institute (NCI) to investigate the safety and tolerability of GI-6301, a Tarmogen product, for patients with metastatic cancers containing brachyury protein.
The study is an open-label, dose-cohort escalation trial in patients with metastatic cancers with a high incidence of brachyury expression. The primary endpoint of the study is the safety and tolerability of escalating doses of GI-6301 given as a single agent. Secondary endpoints include levels of brachyury-specific T cells, reduction in brachyury serum markers and circulating tumor cells and evidence of clinical benefit.
GI-6301 Tarmogen consists of whole, heat-killed, recombinant S. cerevisiae yeast genetically modified to express high levels of brachyury protein. Brachyury is over-expressed in cancer cells compared with normal tissue and is believed to play a significant role in the progression of cancer from a localized to metastatic disease (the epithelial-to-mesenchymal transition). Targeting brachyury using the GI-6301 Tarmogen is intended to arrest progression of disease by eliminating the subset of tumor cells that acquire drug resistance and the ability to migrate and invade distant tissues.
GI-6301 Tarmogen was jointly developed by GlobeImmune and NCI under a Collaborative Research and Development Agreement (CRADA).
Release Date: Feb. 8, 2012