Short-term administration of CGEN-15001 shown
to provide long-term prevention of disease development
Tel Aviv, Israel, October 9, 2013 — Compugen Ltd. (NASDAQ: CGEN), announced today that CGEN-15001, an Fc fusion protein drug candidate derived from a novel immune checkpoint protein discovered by Compugen, has been shown to be highly efficient in preventing the development of disease in a well-accepted animal model of autoimmune type I diabetes, known also as juvenile diabetes. The study was performed as part of an ongoing collaboration with Stephen Miller, Professor of microbiology-immunology at Northwestern University Feinberg School of Medicine.
The study utilized non-obese laboratory mice that spontaneously develop autoimmune insulin dependent diabetes. Administration of CGEN-15001 to the mice began at 10 weeks of age, prior to manifestation of any clinical symptoms of the disease, and was continued for a period of only 2 weeks. The mice were then monitored for blood glucose levels for an additional 4 months after the last treatment.
Results of the study demonstrate that treatment with CGEN-15001 prevented development of diabetes throughout the 4 months of follow-up. Animals treated with CGEN-15001 maintained normal blood glucose levels compared with untreated animals that developed high blood glucose. The sustained duration of response following a short-term treatment with CGEN-15001, also observed previously in other disease models of autoimmunity, suggests that CGEN-15001 turns off the autoimmune process and may potentially lead to restoration of immune tolerance and resolution of autoimmunity, thereby arresting disease progression.
“We have already shown through various preclinical studies that CGEN-15001 has the potential to serve as an efficacious disease modifying therapy for multiple sclerosis and rheumatoid arthritis,” said Anat Cohen-Dayag, Ph.D., Compugen’s President and CEO. “The results being reported today show that this Fc fusion protein also has a remarkable effect in a well-accepted disease model of type I diabetes, a severe, life-long disease with no current cure. These findings highlight the potential of CGEN-15001 to treat multiple autoimmune conditions and the promise of developing new effective immune modulating therapeutic drug candidates based on Compugen’s discovery platforms.”
About CGEN-15001 and Immune Checkpoints
CGEN-15001 is a novel Fc fusion protein drug candidate consisting of the fusion of an IgG Fc domain to the extracellular region of CGEN-15001T. CGEN-15001T is a novel immune checkpoint discovered by Compugen through its predictive discovery infrastructure and has been shown to have significant potential as a target for cancer immunotherapy.
Immune checkpoints are inhibitory receptors, which are crucial for the maintenance of self-tolerance (that is, the prevention of autoimmunity) and for the protection of tissues from damage when the immune system is performing its intended function of responding to pathogenic infection. Autoimmune diseases, such as type I diabetes, multiple sclerosis and rheumatoid arthritis, are mediated by self-reactive T cells that have escaped immune tolerance to self-proteins.
To date, two soluble recombinant fusion proteins, both derived from the CTLA4 immune checkpoint, have been cleared for marketing in the U.S.: Orencia for the treatment of moderate to severe rheumatoid arthritis, and Nulojix for the prophylaxis of organ rejection in adults receiving a kidney transplant.
About Type I Diabetes
Type 1 diabetes, also known as insulin-dependent or juvenile diabetes, is a chronic disease in which the pancreas produces little or no insulin, a hormone necessary for control of blood sugar levels. The disease is caused by an autoimmune process whereby self-reactive T cells specifically attack and destroy the insulin-producing cells of the pancreas. Currently, type I diabetes has no cure, and treatment consists of life-long administration of insulin. Even with insulin treatment, type I diabetes may lead to serious complications, which can include: kidney failure, blindness, nerve damage, heart attack, stroke, and pregnancy complications.
Compugen is a leading drug discovery company focused on therapeutic proteins and monoclonal antibodies to address important unmet needs in the fields of immunology and oncology. The Company utilizes a broad and continuously growing integrated infrastructure of proprietary scientific understandings and predictive platforms, algorithms, machine learning systems and other computational biology capabilities for the in silico (by computer) prediction and selection of product candidates, which are then advanced in its Pipeline Program. The Company’s business model includes collaborations covering the further development and commercialization of selected product candidates from its Pipeline Program and various forms of research and discovery agreements, in both cases providing Compugen with potential milestone payments and royalties on product sales or other forms of revenue sharing. In 2012, Compugen established operations in California for the development of oncology and immunology monoclonal antibody therapeutic candidates against Compugen drug targets. For additional information, please visit Compugen’s corporate website at www.cgen.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, include words such as “may,” “expects,” “anticipates,” “potential,” “believes,” and “intends,” and describe opinions about future events. Forward-looking statements in this press release include, but are not limited to, statements relating to the potential of CGEN-15001 to treat multiple autoimmune conditions, including, multiple sclerosis, rheumatoid arthritis and type 1 diabetes and the promise of developing new effective immune modulating therapeutic drug candidates based on Compugen’s discovery platforms. 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 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, 2012 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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