Fab’entech’s EMER-IT Project Granted Granted 9,5 Million Euros From OSEO

Paris, France, 22 February 2012

The number of emerging infectious diseases is increasing notably over the last decades. Especially, the emergence or the reemergence of highly pathogenic viruses is observed, specifically those viruses with high pandemic potential like SARS, Ebola and Avian Flu H5N1, for which currently there is no satisfactory treatment option.

The EMER - IT project (IMMUNOTHERAPHY against EMERGING diseases) supported by OSEO, will be able to serve a public health need and an economic necessity in a context where the sanitary shield needs to be reinforced and where the Governments promote an anti - infective political approach in order to be able to face the emerging health risks with a rapid employment of safe and innovative products supported by responsive and flexible industrial manufacturing processes.

The EMER - IT project is a promising collaboration which will spread over 5 years with a total budget of 20 million euros. An amount of 9,5 million euros of financial support will be provided by OSEO, 7,1 million euros of which will be received by Fab’entech, 1,2 million euros by In Cell Art and 1,2 million euros by the public laboratories.

Thus, the EMER - IT project will not only be able to accelerate the development of effective immunotherapy solutions against these emerging health risks but also pave the way for the production and the commercialization of these solutions.

A complete value chain will be employed for developing, producing and commercializing specific polyclonal immunoglobulins [F(ab’) 2 ] against at least four emerging pathogens with no therapeutic solutions (such as Ebola hemorrhagic fever or Lassa, encephalitis of Nipah, SARS...). The specific polyclonal immunoglobulins in question are considered in the continuity of similar products against Crimean - Congo hemorrhagic fever virus (CCHFV) and avian influenza virus A(H5N1), currently in development at Fab’entech.

Press Release Specific polyclonal immunoglobulins directed against these emerging pathogens will be produced by Fab’entech through an ambitious immunization approach that will be implemented by using the methods of synthetic nano - vectorization of antigens in DNA form of In - Cell - Art. This process will be combined with the expertise of the Human Virology Laboratory of ENS of Lyon in the field of VLPs (Virus Like Particles) and that of the UMR - 1087, University of Nantes in the field of adjuvants.

This project will also allow In - Cell - Art to initiate the development of equine influenza vaccine candidates by using these patented nanocarriers and it would lead to future applications for other species.

The production process of these immunoglobulins is historically validated, mastered and recognized internationally. The target of this project will be for Fab’entech to establish an autonomous and pilot production site in the Rhône - Alpes region. By doing so, a high - capacity purification unit of specific immunoglobulin polyclonal will be put in place by utilizing innovative and advanced equipment (disposable solutions, etc...) unique to this type of activity.

In regard to public health, the project has two main targets; on the one hand the project will produce immunotherapeutic solutions to the currently affected countries and thereby providing relief to public and health workers in their fight against a potential pandemic, on the other hand the project will function as a reinforcement of a sanitary shield for those countries which are threatened by the spread of the emerging infectious diseases in question.

Claude Pinault, Director of the Strategic Industrial Innovation Program of OSEO comments: “The assistance provided to the EMER - IT project is part of the ISI (Strategic Industrial Innovation) program whose purpose is to help collaborative projects engaging at least two French SME’s which must contribute to create or to strengthen new European or world champions. This project proposed by Fab’entech alongside its three partners, ideally meets all the criteria required. We are very pleased to contribute to the advancement of this project that we deem extremely promising.”

A national project of international standards, EMER - IT fosters the synergy and the complementarity between its partners that intervene at different phases of the value chain with their complementary expertise: * Fab’entech (Lyon), the leader of the EMER - IT project, brings its expertise in the development and the production of the specific polyclonal immunoglobulins [F(ab’) 2 ] which will be later produced in an autonomous and pilot production site.

* The company In - Cell - Art (Nantes) employs its patented nanocarriers which can dramatically increases the expression and immunogenicity of the gene - encoded antigen to support this consortium. In - Cell - Art also contributes to the conceptualization and the development of new generation of immunogens for the production of specific polyclonal immunoglobulins and the development of veterinary DNA vaccines.

* The INSERM Jean Mérieux BSL - 4 Laboratory of Lyon brings unrivaled scientific expertise on risk group 4 agents and also its technical capacity required for the implementation of experiments on highly pathogenic agents.

* The Human Virology Laboratory, Inserm U758 - ENS of Lyon and l’institut du thorax, Inserm UMR 1087 - CNRS UMR 6291 - University of Nantes undertake the development of VLP (Virus - Like Particles) and new adjuvants in synergy with DNA vaccination of In - Cell - Art.

Beyond these project partners directly supported by OSEO, the EMER - IT project will also engage partners like IDD Biotech and other industrial partners in the region which will be intervening in the industrialization phase of the project.

The complementarity of these internationally recognized partners will enable us to respond rapidly to growing challenges in the fight against emerging diseases by retaining all the flexibility and the responsiveness required to control the infectious pathologies related to highly dangerous and potentially mutative viruses,” underlines Dr. Bertrand Lépine, the founder and the CEO of Fab’entech, and adds: “I thank all the partners of the EMER - IT project, LyonBiopôle and the OSEO teams for their confidence and contribution to this ambitious project. We are assured that this project will bring effective and adapted solutions in our fight against emerging diseases.”

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