GlobeImmune® is a private biopharmaceutical company developing targeted molecular immunogens (Tarmogen® products) for the treatment of cancer and infectious diseases. GlobeImmune has two products in randomized Phase 2 clinical trials. GI-5005 is being evaluated in patients with chronic hepatitis C infection (HCV), as both a front-line therapy in combination with standard of care, and as a monotherapy for second line salvage in interferon intolerant patients. GI-4000 is being evaluated in patients with pancreas, lung and colorectal cancers caused by mutations in the Ras oncogene product. To date, Tarmogens have been generally well-tolerated, and shown to generate antigen-specific T cell immune responses and improved clinical outcomes in patients.
Four-week Phase 2 clinical trial data show that GI-5005, GlobeImmune’s HCV Tarmogen, doubled viral clearance overall in all major subgroups, and doubled the rapid virologic response (RVR) rate in naïve patients with high viral load. The study compared GI-5005 plus standard of care (SOC) - pegylated-interferon plus ribavirin - versus SOC alone in patients with chronic genotype 1 hepatitis C infection.
The Tarmogen technology is a proprietary platform that uses recombinant yeast, engineered to express disease-specific antigens. Tarmogens naturally couple a patient’s innate immune response against the yeast, with an antigen specific T cell response against cells throughout the body that express the same protein contained in the yeast. Tarmogens can be given repeatedly, boosting the T cell response with each subsequent dose. Tarmogens are produced using fermentation processes which can be simply and economically scaled up to commercial levels.