GlobeImmune, Inc. is a private company developing Tarmogen^® therapeutic vaccines that activate a patient’s immune system to target diseased cells.  The company has two lead clinical products; GI-5005 to treat chronic hepatitis C (HCV) infection, and GI-4000 for pancreas, non-small cell lung, colorectal and other cancers driven by mutations in the Ras oncogene product.

GI-5005 stimulates immune-mediated clearance of infected cells, an approach that is synergistic with the antiviral mechanisms of both the current standard of care (SOC) and emerging novel therapies for HCV.  In a randomized phase 2b trial, GI-5005+SOC achieved a 58% sustained virologic response (SVR; or “cure” rate), significantly improved liver function, and had an excellent safety/tolerability profile.  Moreover, the greatest therapeutic effect (60% SVR GI-5005+SOC vs. 0% SOC-alone) occurred in patients genetically predisposed to be hardest-to-treat with SOC alone (IL28B T/T patients), a predisposition occurring with increased incidence in Hispanics and a 3-fold higher incidence in African-Americans. 

GI-4000 is being investigated in multiple phase 2 clinical trials in a variety of tumor types containing mutated Ras.  In a phase 1 monotherapy study in metastatic cancers, GI-4000 was well-tolerated and induced antigen-specific T cell immune responses in patients.  In preclinical models GI-4000 induced complete remission of tumors bearing the targeted mutations, and did so in a mutation-specific manner.   In May 2009, the company announced a global partnership with Celgene focused on the discovery, development and commercialization of multiple product candidates for the treatment of cancer.