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Effimune With Its Lead Drug Candidate FR104, Has Been Selected Through the Consortium TRIAD, Under the European Union FP7 Funding Program


2/13/2012 8:57:40 AM

Nantes, France, 13 February 2012. The French biotech company Effimune today announced that it has signed a funding agreement with the European Commission for its Tolerance Restoration in Autoimmune Diseases (TRIAD) project. As part of the sixth call for proposals under the European Union's FP7-HEALTH-2011 programme (with emphasis on the development and validation of new therapies in autoimmune disorders and inflammation), TRIAD has been selected to receive a total of €3 million in funding over a 3-year period. Effimune Chairman Maryvonne Hiance commented that “Projects supported by European commission are subject to a very strict selection, regarding their scientific aspects and impact, but also the market and competition. The TRIAD project crossed this rigorous selection and we are extremely enthusiastic to coordinate this program along with our highly motivated partners.”

The TRIAD project is based on an innovative but well-characterized antibody-based approach for the treatment of autoimmune disorders. The project's main objective is to preclinically evaluate a selective CD28 antagonist for the prevention, treatment and/or cure of several autoimmune disorders, including rheumatoid arthritis, multiple sclerosis, type 1 diabetes, psoriasis, uveitis and arteriosclerosis. Rather than suppressing the immune system as a whole, this novel approach suppresses only those parts of the immune system responsible for the autoimmune attack, while sparing and enhancing regulatory T cells. Co-stimulation through the CD28/B7/CTLA-4 molecular triad controls the balance between effector and regulatory functions after initial antigen exposure. A drug candidate based on CD28 antagonism would enable very specific immunosuppression and would be compatible with regulatory T cell function, immune regulation and therefore the induction and restoration of immune tolerance. In other words, this type of treatment should be less aggressive for patients than current treatments with an impact on the immune system as a whole.

The TRIAD project will start by studying the preclinical efficacy and safety of a novel, selective CD28 antagonist (FR104). Success at this stage will enable Effimune to initiate Phase I/II clinical trials in patients.

TRIAD capitalizes on the strong skills in immunology available in Brazil and Europe. The consortium comprises Effimune and six academic institutions: INSERM and Nantes University Hospital in France, Oxford University and Glasgow Caledonian University in the UK, the Biomedical Primate Research Centre in the Netherlands and Instituto Israelita de Ensino e Pesquisa Albert Einstein in Brazil.

About Partner 1 (Coordinator): Effimune (formerly TcL Pharma)

Located in Nantes (France), Effimune is a biotech company dedicated to the discovery and development of drugs which regulate the immune system in autoimmune disease and transplantation. As a member of the Atlanpole Biotherapies cluster, the company was spun out of the Institute for Transplantation Urology, Nephrology (ITUN, Europe’s leading centre for kidney and combined kidney/pancreas transplantation) in December 2007.

The first monoclonal antibodies developed by Effimune (FR104, MD707 and MP196) are based on novel approaches to immune system regulation. Effimune is focusing its efforts on drug development in the field of autoimmune disorders and transplantation. The company's expertise encompasses all the steps in drug development, including target characterization, drug discovery, proof-of-concept, pilot manufacturing, regulatory preclinical development and first-in-man Phase I and II clinical trials. Effimune is developing the CD28 antagonist FR104, the first ever biologic drug with selective immunosuppressive activity. The company's expertise has made it possible to select and engineer a monovalent anti-CD28 antibody (to make it purely antagonist and to tune its pharmacokinetic profile) and develop its production. Effimune is currently the only partner able to provide and develop the material needed to achieve the TRIAD project's objectives.

For more information, visit www.effimune.com

About Partner 2, the Biomedical Primate Research Centre

Located in the Netherlands, the Biomedical Primate Research Centre (BPRC) is dedicated to health research and uses validated models of major human diseases in non-human primates. The institute has unique, genetically typed colonies and its Immunobiology Department is an internationally recognized leader for research on chronic inflammatory diseases in primates. The BPRC specializes in three species: rhesus monkeys for infectious disease research (malaria, tuberculosis and AIDS) and chronic inflammatory diseases (rheumatoid arthritis and multiple sclerosis), cynomolgus macaques for ethology research and, lastly, common marmosets for studying rheumatoid arthritis, multiple sclerosis and the neurodegenerative Parkinson's disease.

About Partner 3, the University of Oxford

The University of Oxford is one of the UK's leading universities, with a strong Infection and Immunity research programme that encompasses basic, translational and clinical studies. The programme received the highest possible rating in the 2008 Research Assessment Exercise. Transplantation is a key theme within the Infection and Immunity and Translational Medicine programmes. Professor Kathryn Wood and colleagues in the Transplantation Research Immunology Group (TRIG – www.nds.ox.ac.uk/trig ) work closely with the clinical transplant programme to define the research agenda and enable rapid translation of laboratory findings into clinical practice. The group is located within the University's Nuffield Department of Surgical Sciences at John Radcliffe Hospital (Oxford). Professor Wood’s team has extensive experience of using humanised models to study inflammation in vivo - an essential skill for the TRIAD project.

About Partner 4a, INSERM Unit 643 (part of the French National Institute for Health and Medical Research)

Located in Nantes (France), INSERM U643 is part of Europe's largest centre for kidney transplantation and has acquired a worldwide recognition in immunology and translational research in immunosuppression. For example, the Unit was the first to introduce anti-IL2Ra therapeutic antibodies into the clinic. INSERM U643 has set up the Large Animal Laboratory, a BiogenOuest- accredited research platform for the preclinical evaluation of novel therapies. The INSERM U643 also hosts the CIMNA Nantes Immunomonitoring Centre, which offers all the latest technologies for monitoring and analysing the immune response (especially in the primate). This expertise will be essential for other partners in the TRIAD project, who will either send samples to the INSERM U643 or take advantage of protocol exchanges. The combination of primate facilities and top-level immunomonitoring is unique in Europe.

About Partner 4b, INSERM Unit 1013

Located in Paris (France), INSERM U1013 is part of Paris Descartes University's Faculty of Medicine (located on the Necker Children's' Hospital campus – France's top biomedical research campus and a leading location for immunology research). The campus comprises 26 research units and numerous core facilities, including cell sorting, imaging, genomics, gene transfer and proteomics. Research work focuses on the cellular and molecular immune mechanisms that sustain peripheral tolerance and control the pathogenic activity of autoreactive T effector cells (mainly using the non-obese diabetic mouse model of autoimmune diabetes). Major efforts are also devoted to establishing new, biologic- based immune intervention strategies for promoting and/or restoring immune tolerance. Professor Lucienne Chatenoud and her group have performed pioneering work in the field of monoclonal antibodies. The TRIAD project will benefit from the group's expertise of the use of biological agents in tolerance-inducing protocols applied to well-defined murine models of autoimmunity.

About Partner 5, Instituto Israelita de Ensino e Pesquisa Albert Einstein)

The Instituto Israelita de Ensino e Pesquisa Albert Einstein (IIEP, the Albert Einstein Educationand Research Institute) was established in 1998 through the merger of the Hospital Israelita Albert Einstein’s Nursing School, Technical School and Research & Development Laboratory. The IIEP grew rapidly after the opening of its new headquarters in 2002. Its mission is to “become a benchmark in research, development and the dissemination of healthcare knowledge for the benefit of the Brazilian society”. Today, IIEP is one of the unique features that make the Hospital Israelita Albert Einstein a pioneer in healthcare. IIEP works closely with major scientific research institutes both in Brazil and around the world, as well as national and international development agencies and governmental organisations. The Institute will study FR104's effect on the development and progression of experimental autoimmune uveitis (EAU), a disease model for organ-specific autoimmunity in the eye. The IIEP helped to develop the animal model in the early 1990s and has become one of the world's leading experts in this field. It has specific expertise in all aspects of this animal model: testing novel, innovative therapeutic strategies and evaluating immune parameters (cell populations, cytokine/antibody production, gene expression, behavioural changes, etc.).

About Partner 6, Glasgow Caledonian University

Glasgow Caledonian University (GCU, comprising three academic schools in the areas of business, health and life sciences, and engineering and the environment. It is the 5th largest university in Scotland and is currently top in Scotland and in the top 8 in the UK for Applied Health Research. The schools contain state-of-the-art laboratories and a number of renowned centres of excellence. These results reinforced and provided the springboard to take forward GCU's strategic vision to support world-leading research in selected areas of strategic focus. As such, a new Research Institute for Applied Health Research (IAHR) was established in 2009 as a strategic priority for the University to further enhance key areas of research excellence. Research grant funding within the IAHR comes from the UK research councils, the European Union, the UK National Institute for Health Research, Scottish Government, the National Health Service and a number of industrial companies. Dr Linda Scobie has longstanding research expertise in the area of virology and is a valuable member of the Diabetes Research Group within the IAHR, providing knowledge and expertise concerning the viral status of the animal models used to evaluate target molecules and determine clinical safety when transferring treatments to human recipients. The group's current project focuses on the detection of clinically relevant viruses in humans/animals that are zoonotic or emerging in the field of transplantation.

About Partner 7, Nantes University Hospital

The Centre Hospitalier Universitaire de Nantes (Nantes University Hospital) is the regional university hospital in the Pays de la Loire of France. It is organized around 7 establishments with a total capacity of 2600 beds (1600 of which are for short-term hospitalization). The medical staff performs clinical and research work within a series of institutes. The Institute for Transplantation, Urology and Nephrology (ITUN) encompasses two clinical units (Nephrology and Urology, both of which have transplantation activity) and the INSERM U643 research laboratory (Partner 4a, the main activity of which is immunointervention in experimental allo- and xenotransplantation. The ITUN's clinical activity is performed by a staff of 225 MDs and paramedical staff. The ITUN is one of Europe's leading centres for kidney transplantation (with 179 operations in 2009 and over 4050 since the outset) and pancreas transplantation (26 operations in 2009 and over 300 in total). Nantes University Hospital's experienced staff collaborates with INSERM units in Nantes. One of the project's scientific members has the mandatory expertise of immune monitoring of primates required for the TRIAD programme.

For more information :

Effimune

Maryvonne Hiance,

Présidente

Tél : +33 (0) 240 412 834

Mobile : 33 (0) 680 060 183

mhiance@effimune.com

www.effimune.com

ALIZE RP

Caroline Carmagnol

Tél: 33 1 42 68 86 43

Mobile : 33 6 64 18 99 59

Caroline@alizerp.com

Anne Sophie Cosqueric

Anne-sophie@alizerp.com


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