Data indicating novel mechanism of action for CGEN-15001 in maintaining long-term therapeutic effect presented at International Conference on Immune Tolerance in Amsterdam
TEL AVIV, ISRAEL, September 29, 2014 - Compugen Ltd. (NASDAQ: CGEN) announced today that experimental results supporting CGEN-15001’s induction of long-term autoimmune disease remission in disease animal models, potentially through a novel mechanism of action, are being presented at two sessions at the 3rd International Conference on Immune Tolerance, now being held in Amsterdam, the Netherlands from September 28-30, 2014. The presentations are being given by Joseph R. Podojil, PhD, of Northwestern University Feinberg School of Medicine, and by Iris Hecht, PhD, Principal Scientist at Compugen.
In a poster presentation titled “Tolerogenic and immunomodulatory effects in the EAE model of multiple sclerosis induced by CGEN-15001, an Fc-fused protein derived from a novel immune checkpoint,” Dr. Podojil disclosed data indicating that the durable therapeutic responses to CGEN-15001 treatment, demonstrated in disease animal models, are potentially maintained via regulatory T cells (Tregs), which are known to play critical roles in the maintenance of immune tolerance. These initial results were recently generated as part of Compugen’s collaboration with Prof. Stephen D. Miller, Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine, where Dr. Podojil is a Research Assistant Professor in Prof. Miller’s research group.
Dr. Anat Cohen-Dayag, Compugen’s President and CEO, stated, “Immune tolerance induction, which appears to be central to CGEN-15001’s mode of action, is a highly sought goal for the treatment of autoimmune diseases, including type 1 diabetes, rheumatoid arthritis, multiple sclerosis and psoriasis, and for preventing transplant rejection. Drugs that restore immune tolerance have the potential to provide long-term remission of such diseases and conditions without compromising the ability of the immune system to fight infectious diseases and malignancies.”
The recent experimental results being disclosed by Dr. Podojil are based on the R-EAE mouse model of multiple sclerosis, in which short-term administration of CGEN-15001 results in long-term disease remission. The inactivation of Tregs in CGEN-15001 treated R-EAE mice during the disease remission period resulted in disease relapse, strongly suggesting that Tregs are essential for maintenance of CGEN-15001’s long-term therapeutic effect. Additional experimental results in the R-EAE model presented by Dr. Podojil, using blockade of central pathways for Treg induction andfunction, further support involvement of Tregs in the in vivo mechanism of action of CGEN-15001.
The potential of CGEN-15001 to restore immune tolerance will also be the subject of Dr. Hecht’s oral presentation at the conference tomorrow. In her talk entitled “CGEN-15001, a novel immune-modulatory Fc fusion protein is efficacious in models of autoimmune diseases and induces immune tolerance,” Dr. Hecht will present an overview of Compugen’s prior experimental results for CGEN-15001, demonstrating long-lasting efficacy in animal models of several autoimmune diseases. In addition, she will present data supporting restoration of immune tolerance as a potential mechanism of action providing such long-lasting therapeutic potential.
About Immune Tolerance
Immune tolerance is the normal state in which the immune system is programmed to avoid attacking the body’s own cells and tissues. When immune tolerance is compromised, the immune system can mistakenly identify the body’s own cells or tissues as foreign invaders, leading to various autoimmune diseases, such as type 1 diabetes, multiple sclerosis, rheumatoid arthritis or psoriasis. Reprogramming the immune system to re-establish tolerance, termed tolerance induction, can lead to a sustained resolution of auto-immunity and disease remission, as opposed to current therapeutic approaches that rely on suppressing the immune system. Suppression of the immune system can compromise the capacity of the immune system to fight infectious diseases and malignancies, leading to severe side effects. Therefore, induction and maintenance of immune tolerance is widely recognized as a key goal in the treatment of autoimmune diseases.
CGEN-15001 is a novel 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 through its predictive discovery infrastructure. CGEN-15001 was shown to be effective in treating several autoimmune diseases in animal models, including models of multiple sclerosis, rheumatoid arthritis, psoriasis and type 1 diabetes. In preclinical models, CGEN-15001 treatment has been shown to induce a durable long-term response suggestive of immune tolerance restoration. CGEN-15001 has also promoted graft survival in a model of bone marrow transplantation. Further research demonstrated that CGEN-15001 has an immune modulatory function attenuating inflammatory responses and promoting regulatory anti-inflammatory activity, including the promotion of regulatory T cells.
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 product candidates at various stages 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. Compugen’s wholly-owned U.S. subsidiary located in South San Francisco is developing monoclonal antibody therapeutic candidates against its novel 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, including statements relating to the potential of CGEN-15001 to restore immune tolerance through the involvement of Tregs or otherwise and the potential of drugs that restore immune tolerance to provide long-term remission of autoimmune diseases without compromising the ability of the immune system to fight infectious diseases and malignancies. Forward-looking statements can be identified by the use of terminology such as “may,” “expectations,” “approximately,” “further” and “potential” 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 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, 2013 as filed with the Securities and Exchange Commission, as well as other documents that may be subsequently filed by Compugen from time to time 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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