HOLON, Israel, January 4, 2017 /PRNewswire/ --
Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug
discovery company, disclosed today new animal model results
demonstrating restoration of immune tolerance by CGEN-15001, the
Company's lead candidate for treatment of autoimmune diseases.
Importantly, the immune tolerance established by CGEN-15001 was
shown to be antigen-specific, indicating that treatment with
CGEN-15001 has the potential to not only generate a durable
response, but also to avoid the global immune suppression generated
by other therapeutic agents for autoimmune diseases. CGEN-15001 is
an Fc fusion protein based on a Compugen-discovered novel immune
checkpoint protein.
Restoring long-lived immune tolerance and homeostasis, with the
desired result of a durable therapeutic response in patients, is
one of the greatest challenges of immunology and remains a major
unmet need in the treatment of autoimmune diseases. The new
findings being disclosed today, along with supporting data from
earlier research by the Company, demonstrate that CGEN-15001, a
first-in-class therapeutic candidate, has the potential to restore
immune tolerance and re-establish immune homeostasis, thus
potentially offering patients a durable therapeutic response and a
safer treatment profile.
Anat Cohen-Dayag, Ph.D., CEO and
President of Compugen, stated, "Autoimmune diseases, such as
multiple sclerosis, rheumatoid arthritis, type 1 diabetes and
psoriasis, are conditions in which the immune system attacks the
body's healthy tissues due to loss of self-tolerance. Restoring
this tolerance without impacting the immune system's ability to
fight other diseases is the Holy Grail of immunology. Currently,
most drugs indicated for autoimmune diseases are general
immuno-suppressants, which may lead to serious side effects
including infections and an elevated risk of cancer. Our results to
date indicate that CGEN-15001 can provide a promising, novel
therapeutic approach for treatment of a wide range of autoimmune
diseases by restoring immune tolerance without compromising the
protective function of the immune system. As previously disclosed
by the Company, this effect of CGEN-15001 appears to be associated
with its ability to enhance differentiation of regulatory T cells
(Tregs), a population of immune cells that plays a pivotal role in
maintaining immune tolerance. Therefore, we very much look forward
to further advancing this exciting therapeutic opportunity into the
clinic with an appropriate partner."
The data being disclosed today from recent studies conducted in
collaboration with Professor Stephen
Miller, from the Feinberg School of
Medicine at Northwestern University, demonstrate that in
animal models of relapsing-remitting multiple sclerosis (often used
to evaluate potential autoimmune disease therapies), immune
tolerance can be transferred from diseased donor mice treated with
CGEN-15001 to recipient naïve mice. More importantly, this immune
tolerance was shown to be antigen-specific, as the transfer of T
cells from diseased donor mice treated with CGEN-15001 resulted in
protection of the recipient mice from developing the disease in
response to the specific antigen driving the disease at the time of
treatment with CGEN-15001.
In contrast, and under the same conditions, the transfer of T
cells from diseased mice treated with a mouse version of CTLA4-Ig
(a marketed immune checkpoint-based drug for autoimmunity) to
recipient naïve mice did not protect the recipient mice from
developing the disease, indicating no induction of immune tolerance
with this drug. This lack of protection was observed despite the
fact that both CGEN-15001 and CTLA4-Ig were similarly efficacious
in decreasing the clinical symptoms in the diseased donor mice.
Professor Miller stated, "This observation is of significance
since CGEN-15001 appears to not only act as an immune tolerance
inducing agent, but also to act in an antigen-specific manner, thus
having the potential to benefit patients with a long-lived drug
free remission while avoiding the global immune suppression induced
by other treatments. This data therefore supports a safety profile
for CGEN-15001 with potentially low risk for infections and
neo-malignancies which are unfortunately recognized side effects of
many of the currently available drugs for autoimmunity."
About CGEN-15001
CGEN-15001 is an Fc fusion protein drug candidate for autoimmune
diseases, consisting of the fusion of the extracellular region of
CGEN-15001T to an IgG Fc domain. CGEN-15001T is a novel immune
checkpoint discovered by Compugen using its broadly applicable
predictive discovery infrastructure. CGEN-15001 was previously
shown to be effective in treating several autoimmune diseases in
animal models, including models of multiple sclerosis, rheumatoid
arthritis, type 1 diabetes and psoriasis. In some of these models,
a short period of treatment with CGEN-15001 was shown to induce a
durable long-term response suggestive of an immune tolerance
mechanism. Additional studies demonstrated that CGEN-15001 has an
immuno-modulatory function manifested in attenuating inflammatory
responses and promoting regulatory and anti-inflammatory
activities, including the differentiation of regulatory T cells
(Tregs), a population of immune cells that plays a pivotal role in
induction and maintenance of immune tolerance. Importantly, the
long-term therapeutic effect of CGEN-15001 appears to be associated
with its ability to enhance the differentiation of Tregs.
About Immune Tolerance
Immune tolerance is the normal healthy state in which the immune
system is programmed to avoid attacking the body's own cells and
tissues. Improper immune tolerance characterizes both cancer and
autoimmunity. While in cancer the therapeutic goal is to break
immune tolerance towards tumor antigens and thereby unleash the
immune system to attack the tumor cells, in autoimmunity the goal
is to restore immune tolerance towards the body's healthy cells and
thereby protect such cells from an immune attack.
In autoimmunity, the immune system mistakenly identifies the
body's own cells or tissues as foreign invaders, due to breach of
self-tolerance, leading to various autoimmune diseases such as
multiple sclerosis, rheumatoid arthritis, type 1 diabetes, or
psoriasis. Reprogramming the immune system to restore tolerance and
re-establish homeostasis can lead to a sustained resolution of
autoimmunity and disease remission. In contrast, current
therapeutic approaches that rely on suppressing the immune system
can compromise its capacity to fight infectious diseases and
malignancies, leading to the potential of severe side effects.
Therefore, induction and maintenance of immune tolerance is widely
recognized as a key unmet need in the treatment of autoimmune
diseases.
Targeting immune checkpoints to restore immune tolerance in
autoimmunity is a promising approach anticipated to bring a
paradigm shift in the treatment of autoimmunity similar to advances
now being made by immune checkpoint-based therapies in
immuno-oncology.
About Compugen
Compugen is a leading therapeutic discovery company utilizing
its broadly applicable predictive discovery infrastructure to
identify novel drug targets and develop first-in-class biologics.
The primary focus of the Company's current pipeline is on immune
checkpoint target candidates discovered by the Company, potentially
providing the basis for a next wave of therapeutics for cancer
immunotherapy. Compugen's business model is based on selectively
entering into collaborations for its novel target candidates and
drug product candidates at various stages of research and
development under revenue-sharing agreements. The Company is
headquartered in Israel, with
R&D facilities in Israel and
South San Francisco. At the US facilities, monoclonal antibody
therapeutic candidates are discovered and developed against the
Company's novel target candidates. For additional information,
please visit Compugen's corporate website at
http://www.cgen.com.
Forward-Looking Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by the use of
terminology such as "will," "may," "expects," "anticipates,"
"believes," "potential," and "intends," and describe opinions about
possible 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. Among
these risks: Compugen's business model is substantially dependent
on entering into collaboration agreements with third parties, and
Compugen may not be successful in generating adequate revenues or
commercializing aspects of its business model. Moreover, the
development and commercialization of therapeutic candidates involve
many inherent risks, including failure to progress to clinical
trials or, if they progress to or enter clinical trials, failure to
receive regulatory approval. These and other factors are more fully
discussed in the "Risk Factors" section of Compugen's most recent
Annual Report on Form 20-F as filed with the Securities and
Exchange Commission (SEC) as well as other documents that may be
subsequently filed by Compugen from time to time with the SEC. 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.
Company contact:
Susanna Chau
Director, Investor Relations and Corporate Communications
Compugen
Email: susannac@cgen.com
Tel: +1-650-263-7001
SOURCE Compugen Ltd.