Compugen Announces Validation of Two Immune System Modulating Drug Candidates
September 13 2011 - 6:00AM
Business Wire
Speaking today at the Rodman & Renshaw Annual Global
Investment Conference in New York City, Martin Gerstel, chairman of
Compugen Ltd. (NASDAQ: CGEN), reviewed the current status of the
Company and announced the validation of two therapeutic product
candidates, CGEN-15021 and CGEN-15091, in various autoimmune
disease animal models. These two molecules are soluble proteins
based on two B7/CD28-like proteins recently discovered by Compugen.
In view of its key role in modulating immune response, the B7/CD28
family of proteins is of high interest in medical research and to
the pharmaceutical industry, and these newly discovered molecules
share key characteristics with this protein family. In addition to
the potential use of CGEN-15021 and CGEN-15091 as protein
therapeutics for multiple autoimmune diseases, the two proteins
they are based on are predicted to have utility as drug targets for
monoclonal antibody therapy in oncology.
CGEN-15021 and CGEN-15091 are both soluble fusion proteins, each
combining the extracellular domain of one of the newly discovered
B7/CD28-like proteins and an Fc antibody fragment. Fusion to an Fc
antibody fragment is an established methodology to create soluble
long-acting therapeutic proteins. The results being announced today
relate to the recent validation of CGEN-15021 in animal disease
models of both multiple sclerosis and rheumatoid arthritis, and 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.
In his presentation (which has been posted on Compugen’s
website: www.cgen.com), Mr. Gerstel stated, “The discovery process
for these two immunomodulatory proteins is an excellent example of
the power and uniqueness of the broad based scientific
infrastructure for predictive discovery that has been established
at Compugen over the past decade. This infrastructure now allows
the rapid development of accurate in silico capabilities for the
prediction of innovative therapeutic solutions in selected areas of
unmet medical need. In this case, we initially directed these
capabilities to the B7/CD28 protein family, a protein family of
very high industry interest due to its key role in regulating
immune responses, and one with significant therapeutic potential in
major pathological conditions, such as autoimmune diseases,
transplantation and cancer.”
Mr. Gerstel continued, “Within approximately six months, we had
integrated multiple components of our infrastructure capabilities
to develop the Protein Family Members Discovery Platform, which
during its initial discovery process, predicted nine new proteins
sharing characteristics with the B7/CD28 protein family. The first
three of these nine, consisting of the previously disclosed
CGEN-15001 which is currently moving forward in our Pipeline
Program, and the two proteins for which positive in vivo results
are being announced today, have now been validated in established
animal disease models. In addition, we subsequently extended this
discovery capability beyond the B7/CD28 family, as well as
developing additional capabilities for the discovery of other types
of immune related proteins, some of which are now beginning the
validation process.”
Mr. Gerstel continued, “With respect to today’s disclosure, the
in vitro validation experiments and the in vivo study in a multiple
sclerosis animal model of CGEN-15021 and CGEN-15091 were part of
Compugen’s long-term research agreement with Prof. Stephen Miller’s
laboratory at Northwestern University. The in vivo validation of
CGEN-15021 in a rheumatoid arthritis model was conducted at Dr.
Richard Williams’ laboratory at the Kennedy Institute of
Rheumatology, Oxford University. Having long-term relationships
with leading scientists at academic laboratories with well
established assays and animal models, enables Compugen to quickly
and efficiently validate its new discoveries.”
Mr. Gerstel concluded, “We enthusiastically look forward to the
further development of these very attractive drug candidates, and
to the ongoing application of our unique capabilities to additional
areas of unmet medical need.”
About the B7/CD28 Protein Family of positive
and negative co-stimulatory proteins
Members of the B7/CD28 families have been intensively studied
over the past decade and have brought much excitement to the field
of immune regulation. The activation and development of an adaptive
immune response is initiated by the engagement of a T-cell antigen
receptor with an antigenic peptide-MHC complex. The outcome of this
engagement is determined by both positive and negative
co-stimulatory signals, generated mainly by the interaction between
members of the B7 family ligands and their receptors, members of
the CD28 family. A growing body of evidence indicates that the
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.
About Compugen
Compugen is a leading therapeutic product candidate discovery
company, currently focused on biologics-based therapy 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
identified and more fully explained under the heading “Risk
Factors” in Compugen’s annual reports filed with the Securities and
Exchange Commission.
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