Compugen Drug Candidate Demonstrates Attenuation of Autoimmunity and Reestablishment of Immune Balance

Suggested mode of action for CGEN-15001 directly impacts key pathogenic aspects of autoimmune disease

Results from pre-clinical studies for CGEN-15001 immune checkpoint modulator presented at the European Congress of Immunology

TEL AVIV, Israel--(BUSINESS WIRE)--September 10, 2012 07:00 AM Eastern Daylight Time--Compugen Ltd. (NASDAQ: CGEN) announced today that pre-clinical findings presented at the 3rd European Congress of Immunology provide additional support for the potential of CGEN-15001 to effectively treat autoimmune disease. Mode of action studies for CGEN-15001 demonstrated both the active suppression of pathogenic immune responses and the reestablishment of immune balance by increasing anti-inflammatory mediators and promoting inducible regulatory T cells (iTregs). Modulation of iTregs is considered an extremely promising approach for treatment of autoimmunity and cancer, and therefore has been the focus of intense industry and academic research in recent years.

“The very promising results being presented by our collaborators at Northwestern University demonstrate that CGEN-15001 may provide an effective therapy for restoring immune system balance and proper function in the presence of autoimmune disease”
.These results were included in a presentation focused on CGEN-15001 by Dr. Joseph R. Podojil, a Research Assistant Professor in the laboratory of Professor Stephen Miller at Northwestern University, at the 3rd European Congress of Immunology held last week in Glasgow, U.K. In his talk, Dr. Podojil presented data supporting multiple modes by which CGEN-15001 appears to mitigate aberrant immune function leading to autoimmunity. In addition to the data supporting its promotion of iTregs, which was disclosed for the first time at the congress, Dr. Podojil discussed CGEN-15001’s previously reported ability to prevent autoreactive inflammatory immune cell infiltration to the central nervous system as well as its immunomodulatory activity, thereby both turning off pro-inflammatory immune cells and promoting immunoregulatory immune responses.

"The very promising results being presented by our collaborators at Northwestern University demonstrate that CGEN-15001 may provide an effective therapy for restoring immune system balance and proper function in the presence of autoimmune disease,” said Dr. Anat Cohen-Dayag, Compugen’s President and CEO. "Preclinical studies of CGEN-15001 have shown excellent therapeutic effects in established models of both multiple sclerosis and rheumatoid arthritis. Based on the results to date and our recent understandings of its mode of action, we believe that CGEN-15001 has the potential to emerge as an efficacious and safe disease modifying therapy for these and other autoimmune diseases."

Dr. Cohen-Dayag added, “CGEN-15001 is an Fc fusion protein, based on CGEN-15001T, a protein predicted by Compugen as a novel immune checkpoint target. In addition to CGEN-15001’s potential benefits in autoimmune disease therapy, the recent findings further support our cancer treatment strategy with respect to CGEN-15001T. This strategy is based on blocking the CGEN-15001T immune checkpoint protein, which we have demonstrated is expressed on cancer cells, using a therapeutic monoclonal antibody. In this setting the antibody would act to restore the immune system’s ability to attack the tumor."

About CGEN-15001

CGEN-15001 is a novel protein drug candidate being developed by Compugen for the treatment of autoimmune diseases. CGEN-15001 consists of the extracellular region of CGEN-15001T, predicted by Compugen to be a novel B7/CD28-like immune checkpoint target, fused to an antibody Fc domain. CGEN-15001 was demonstrated to have excellent therapeutic effects in animal models of rheumatoid arthritis and multiple sclerosis. Further research demonstrated that CGEN-15001 has an immunomodulatory function attenuating inflammatory responses and promoting regulatory anti-inflammatory activity by immune cells.

About Immune Checkpoints and Inducible Tregs

Immune checkpoints are inhibitory receptors and their ligands, 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 responding to pathogenic infection. In several autoimmune diseases, including multiple sclerosis and rheumatoid arthritis, self-reactive T cells escaped immune checkpoints. Normally, these T cells are regulated and inhibited by regulatory T cells, such as iTregs, which are a specialized class of immune T cells that regulate and attenuate immune responses and are essential in the maintenance of immunologic balance. However, in pathological conditions, self-reactive T cells are activated and autoimmune responses ensue. Therefore, restoring immunologic balance by activating immune checkpoints and regulatory cells is a promising avenue for the treatment of autoimmunity. Immune checkpoints also play critical roles in cancer development as they are "highjacked" by tumors to block the ability of the immune system to destroy the tumor (“immune resistance”), and have lately emerged as potential "game changers" and promising targets for cancer immunotherapy.

About Compugen

Compugen 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. Unlike traditional high throughput trial and error experimental based discovery, Compugen 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 to the pre-IND stage. The Company's business model primarily involves collaborations covering the further development and commercialization of 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-discovered drug targets. 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,” “projects,” “anticipates,” “believes,” and “intends,” and describe opinions about future events. Forward-looking statements in this press release include, but are not limited to, that CGEN-15001 may provide an effective therapy for restoring the immune system balance and proper function in the presence of autoimmune disease and that CGEN-15001 has the potential to emerge as an efficacious and safe disease modifying therapy for autoimmune diseases. 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, including without limitation, corporate partners or licensees; the impact of competitive products and technological changes; risks relating to the development of new products in general; risks relating to the research, development, regulatory approval, manufacturing or marketing of new therapeutic or diagnostic products; the ability to implement technological improvements and risks related to obtaining necessary resources, including, without limitation capital. 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, 2011 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.

Contacts
Compugen Ltd.
Tsipi Haitovsky, +972-52-598-9892
Global Media Liaison
tsipih@netvision.net.il


 

Posted: September 2012

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