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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