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