Speaking today at the 4th Immunotherapeutics &
Immunomonitoring Conference in San Diego, Dr. Galit Rotman, Chief
Scientist of Therapeutics at Compugen Ltd. (NASDAQ: CGEN),
presented data demonstrating the therapeutic efficacy of
CGEN-15001, CGEN-15021 and CGEN-15091 in animal models of multiple
sclerosis (MS), and the therapeutic efficacy of CGEN-15001 and
CGEN-15021 in animal models of rheumatoid arthritis (RA).
CGEN-15001, CGEN-15021 and CGEN-15091 are predicted B7/CD28-like
proteins discovered using Compugen’s Protein Family Members
Discovery Platform.
Dr. Rotman reported that in the collagen induced arthritis model
of RA, treatments with either CGEN-15001 or CGEN-15021 in animals
with established disease resulted in dramatic amelioration of
clinical symptoms. Also, both treatments resulted in reduced damage
to the joints, as evidenced by a histological analysis that
supports the disease modifying potential of these treatments. In
the experimental autoimmune encephalitis mouse model of MS, short
term treatments with CGEN-15001, CGEN-15021 or CGEN-15091 all
resulted in a long term dramatic improvement of disease
symptoms. Specifically for CGEN-15001, results demonstrated
inhibition of pathological immune responses and of epitope
spreading, which underlie the relapsing remitting nature of the
disease. Overall, these results indicate that CGEN-15001 may
prevent disease progression by immune tolerance induction, a
process whereby the immune system no longer attacks the
self-antigens that cause the disease. Modifying such diseases
through immune tolerance induction is a promising mode of action
that may result in effective drugs for autoimmune diseases.
In her talk, Dr. Rotman presented data demonstrating that the
effects of CGEN-15001 include modulating the activity of a
sub-group of white blood cells called T helper cells, which are
known to provide signals for orchestrating the immune response.
CGEN-15001 has been shown to inhibit the pro-inflammatory T helper
cells, Th1 and Th17, while at the same time promoting
anti-inflammatory Th2 responses, a phenomenon known as Th1/Th2
shift. T cell modulation can be therapeutically beneficial in the
treatment of T cell mediated autoimmune diseases such as MS, RA,
diabetes type 1, psoriasis and others. These encouraging results
were demonstrated both by in vitro and in vivo based test systems.
The research involving CGEN-15001 in MS animal models suggests that
it exerts its beneficial therapeutic effect by modulating the
immune system through the Th1/Th2 shift, inhibiting epitope
spreading and preventing infiltration of reactive immune T cells
into the central nervous system.”
Dr. Rotman concluded, “An efficient treatment for autoimmune
diseases with minimal side effects is a major therapeutic need.
Currently, many of the approved drugs act via global immune
suppression, which involves multiple, potentially serious side
effects and expose the body to opportunistic pathogenic attacks.
CGEN-15001, CGEN-15021 and CGEN-15091 offer the opportunity to
regulate the immune response in a specific manner potentially
providing significant therapeutic benefits with fewer side
effects.”
Dr. Anat Cohen-Dayag, Compugen’s president and CEO added, "The
CGEN-15001, CGEN-15021 and CGEN-15091 product candidates are based
on three of the nine novel B7/CD28-like proteins predicted and
selected in silico using our Protein Family Members Discovery
Platform. This platform, which utilizes the integration of multiple
data sources and algorithms modeling biological phenomena, was
designed to predict and select unknown members of protein families
of high industry interest, such as the B7/CD28 family. Members of
this protein family are important regulators of the immune system
and thus can be targets for treatment of autoimmune diseases as
well as cancer immunotherapy."
Dr. Cohen-Dayag concluded, “These and other previously disclosed
preclinical results for our novel B7/CD28-like proteins, the first
protein family upon which we have chosen to focus our Protein
Family Members Discovery Platform, highlight the potential of this
unique platform, a potential we are only beginning to tap."
About CGEN-15001, CGEN-15021, CGEN-15091 and the
B7/CD28 protein familyMembers of the B7/CD28 protein family
have been intensively studied over the past decade as positive and
negative regulators of the immune response. A growing body of
evidence indicates that dysfunction of immune regulation
contributes to the development of autoimmune diseases.
Positive and negative co-stimulatory pathways play critical
roles in immune regulation and are considered potential targets for
modulating chronic inflammation in autoimmune diseases. To date,
one soluble recombinant fusion protein that selectively blocks the
co-stimulatory signal mediated by the prototype B7/CD28 pathway has
been cleared for marketing in the U.S. for the treatment of
moderate to severe rheumatoid arthritis, and is in clinical trials
for other autoimmune indications. In addition, a number of clinical
and preclinical studies for therapeutic agents targeting these
protein families are underway at various companies.
CGEN-15001 is a novel protein drug candidate consisting of the
extracellular region of CGEN-15001T, a previously unknown membrane
protein predicted by Compugen to be a member of the B7/CD28 family,
fused to a mouse antibody Fc domain. CGEN-15001T was discovered
using Compugen’s Protein Family Members Discovery Platform, and was
predicted to have an immunomodulatory function based on its
bioinformatic characteristics. To date, utilization of this
predictive platform by Compugen has resulted in the discovery of
nine proteins predicted to serve as novel members of this family,
including CGEN-15001T and the two proteins that are the basis of
CGEN-15021 and CGEN-15091.
CGEN-15021 and CGEN-15091 are also soluble fusion proteins, each
combining the extracellular domain of one of the new B7/CD28-like
proteins discovered by Compugen, and an Fc antibody fragment. The
therapeutic potential of CGEN-15021 was recently validated in
animal disease models of both multiple sclerosis and rheumatoid
arthritis, and that of CGEN-15091 in an animal disease model of
multiple sclerosis. In each of these disease models, the Compugen
fusion proteins demonstrated dramatic therapeutic effects in
ameliorating disease symptoms. In addition, in earlier in vitro
experiments, CGEN-15021 and CGEN-15091 exhibited inhibition of T
cell activation, confirming their predicted role in the modulation
of the immune system.
About Multiple SclerosisMultiple sclerosis (MS) is
an autoimmune disease that affects the central nervous
system, and is caused by damage to the myelin sheath, the
protective covering that surrounds nerve cells. When this nerve
covering is damaged, nerve impulses are slowed down or stopped. The
nerve damage is caused by inflammation, which occurs when the
body's own immune cells attack the nervous system. In MS, the
immune response is primarily mediated by T cells, that gain entry
into the brain via the blood–brain barrier, but the trigger to this
inflammatory process remains unknown. It is common for the disease
to return (relapse). However, the disease may continue to get worse
without periods of remission. Currently there is no cure for MS,
but several drugs are used for controlling and managing the
disease.
About Rheumatoid ArthritisRheumatoid arthritis (RA)
is a chronic, systemic inflammatory disorder that
affects about 1% of the world population, and is three times more
prevalent in women compared with men. The disease affects mainly
joints, but may also affect other tissues and organs. Although the
cause of rheumatoid arthritis is
unknown, autoimmunity plays a pivotal role in both its
chronicity and progression, and RA is considered a systemic
autoimmune disease. RA can be a disabling
and painful condition, which can lead to substantial loss
of functioning and mobility if not adequately treated. Currently
available pharmacological treatments include
anti-inflammatory drugs, such as steroids and
disease-modifying anti-rheumatic drugs (DMARDs). Due to side
effects associated with current therapies, efforts are being made
to develop a newer group of biologics to increase
treatment options.
About CompugenCompugen is a leading therapeutic product
discovery company focused on therapeutic proteins and monoclonal
antibodies to address important unmet needs in the fields of
immunology and oncology, either for Compugen or its partners.
Unlike traditional high throughput trial and error experimental
based drug candidate discovery, Compugen’s discovery efforts are
based on systematic and continuously improving in silico (by
computer) product candidate prediction and selection followed by
experimental validation, with selected product candidates being
advanced in its Pipeline Program to the pre-IND stage. Compugen’s
in silico predictive models utilize a broad and continuously
growing infrastructure of proprietary scientific understandings and
predictive platforms, algorithms, machine learning systems and
other computational biology capabilities. The Company’s business
model primarily involves collaborations covering the further
development and commercialization of Compugen-discovered product
candidates and various forms of “discovery on demand” arrangements,
in both cases providing Compugen with potential milestone payments
and royalties on product sales or other forms of revenue sharing.
In 2002, Compugen established an affiliate, Evogene Ltd.
(www.evogene.com) (TASE: EVGN.TA), to utilize certain of the
Company's in silico predictive discovery capabilities in
agricultural biotechnology. For additional information, please
visit Compugen's corporate website at www.cgen.com.
This press release may contain “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements include words such as “may”, “expects”,
“anticipates”, “believes”, and “intends”, and describe opinions
about future events. These forward-looking statements involve known
and unknown risks and uncertainties that may cause the actual
results, performance or achievements of Compugen to be materially
different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Some of
these risks are: changes in relationships with collaborators; the
impact of competitive products and technological changes; risks
relating to the development of new products; and the ability to
implement technological improvements. These and other factors are
discussed in the "Risk Factors" section of Compugen’s Annual Report
on Form 20-F for the year ended December 31, 2010 as filed with the
Securities and Exchange Commission. In addition, any
forward-looking statements represent Compugen’s views only as of
the date of this release and should not be relied upon as
representing its views as of any subsequent date. Compugen does not
assume any obligation to update any forward-looking statements
unless required by law.
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