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Alan Franciscus
Editor-in-Chief
HCV Advocate
HBV Advocate

Monday, November 12, 2012

GI-13020 Tarmogen® for the Treatment of Chronic Hepatitis B Generates Antigen-specific T Cell Responses in Key Preclinical Studies

BOSTON, Nov. 10, 2012 – GlobeImmune, Inc. today announced that GI-13020, an investigational therapeutic vaccine designed using the company’s proprietary Tarmogen® product platform for the treatment of chronic hepatitis B virus (HBV) infection, demonstrated immunogenicity in two preclinical studies.  GI-13020, which is being developed in collaboration with Gilead Sciences, Inc., was found to activate antigen-specific CD4 and CD8 T cells, including those that respond to the HBV X, S and Core antigens, which are critical for the development of hepatitis B disease. These data will be presented today at The Liver Meeting 2012 in Boston.

A poster by Guo et al. will include data demonstrating antigen-specific T cell responses generated in mice immunized with GI-13020.  In addition, the data will show that GI-13020 significantly protected mice from tumors engineered to express HBV antigens.  In a second poster by Kemmler et al., Tarmogens elicited HBV-specific T cell responses ex vivo in samples collected from healthy individuals and donors with chronic HBV.  Further analyses showed that the Tarmogens were able to elicit functional immune responses in a clinically relevant model.

“Chronic HBV infection, which is characterized by inadequate and dysfunctional T cell responses against HBV antigens, can be effectively suppressed with long term antiviral therapy. However, there is a significant opportunity to improve permanent cure rates,” said David Apelian, M.D., Ph.D., Senior Vice President, Research & Development, and Chief Medical Officer of GlobeImmune. “We believe that administration of GI-13020 in patients whose disease is under virologic control with a direct acting antiviral agent may have the potential to increase hepatitis B surface antigen seroconversion rates, thus potentially allowing discontinuation of antiviral treatment.”

HBV infection is the most common chronic viral hepatitis infection in the world.  Approximately 350 million people worldwide are chronic carriers of HBV, of whom more than 620,000 die from liver-related disease annually. In theUnited States, chronic HBV infection affects up to two million people. Current treatment for HBV includes oral antiviral therapy with once-daily medicines to suppress virus replication. These antiviral products have been highly effective in controlling the disease but generally do not result in a long-term cure, thus requiring chronic suppressive therapy to control the disease.

About GlobeImmune
GlobeImmune is a biopharmaceutical company focused on developing therapeutic products for cancer and infectious diseases based on its proprietary Tarmogen platform. Tarmogens activate the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines, which stimulate predominately antibody production. To date, Tarmogen product candidates have been generally well tolerated in clinical trials for multiple disease indications and are efficient to manufacture.   In May 2009, the company entered into a collaboration agreement with Celgene Corporation focused on the discovery, development and commercialization of product candidates for the treatment of cancer. In October 2011, the company entered into a worldwide, strategic collaboration with Gilead Sciences, Inc., to develop Tarmogens for the treatment of chronic hepatitis B infection. For additional information, please visit the company’s website at www.globeimmune.com.

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