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NANOFOL

Folate-based nanobiodevices for integrated diagnosis/therapy targeting chronic


inflammatory diseases

1.1. Context and project objectives

It is estimated that inflammatory diseases affect more than 80 million people worldwide
leading to untold suffering, economic loss and premature death. Considering life expectancy
in Europe, these numbers are expected to increase in the next 20 years. Moreover, studies
have shown that disorders such as rheumatoid arthritis (RA) can shorten life span by 10
years.
The treatment of chronic inflammatory disorders, including RA, remains a challenge for the
medical and scientific community. The emergence of new drugs creates new options though
it also entails high costs, complicated drug administration, allergic reactions and
potentially fatal side effects.
Therefore more efficient strategies have to be identified in order to improve inflammatory
disease treatment while decreasing the side effects with an improved cost-benefit ratio.
Nano-enabled drug delivery systems will take therapy of chronic inflammatory
disorders to a new level by creating a new, highly specific and efficient strategy, with
reduced treatment costs.

The NANOFOL project has adopted a specific risk amelioration strategy to attain
objectives in a step-by-step approach in order to gradually improve the concept (specificity,
stability, side effects and efficacy) from lower to higher risk solutions ensuring reduced
animal testing and high human safety.

NANOFOL will improve treatment of chronic inflammatory diseases by fulfilling the following
objectives:
 Design, development and production of nanobiodevices directly targeting effector
cells
 Experimental design that will enable minimal animal experimentation.
 Development of a strategy to assess potential life cycle risks ensuring safe
nanobiodevice-mediated delivery.
 Setting-up better citizen awareness on nanomedicine-based therapies and training
activities.
1.2. Status at M12

NANOFOL has acomplished until now the overall objectives established in the initial plan.
The consortium discussed and defined several possibilities for the global nanodevice
strategy, in order to reach delivery technology products with therapeutic potential. In this first
year the optimal conditions were established for the production of Folate Based
Nanobiodevice (FBN) prototypes, incorporating components (such as folate-surfactant neck
domain peptides) intended to provide both target specificity and improved stability. Our
results suggest that these FBN, liposomal or protein-based nanoparticles can encapsulate
drugs such as celecoxib. These FBN have been tested for internalization in FRα- and FRα+
cells and sugest target cell specificity. The consortium will continue to promote optimization
of production methodologies, such as the proposed development of microreactor systems
which would allow the scale-up of liposome production. Several in vitro models for testing
specific cell uptake of nanodevices, as well as the molecular and biochemical effects of
exposure to such particles, have been established. We were able of identifying candidate
genes for downregulation in activated macrophages by RNA interference. Special attention is
being given to minimizing the use of animal testing by establishing other models. It has
become evident that the macrophage differentiation scheme (M1 versus M2 macrophages),
in particular in humans, must be further clarified. This will contribute not only improved basic
scientific knowledge of rheumatoid arthritis (RA) but also to valid protocols for testing
activated macrophage-targeting therapies. The first anti-FRβ monoclonal antibodies have
been produced and the quest for relevant macrophage-associated target antigens for the
antibody-based bispecific nanobiodevice is underway. NANOFOL nanobiodevices targeting
activated macrophages may become an interesting theranostics solution, i.e. simultaneous
treatment and diagnosis site of inflammation in RA patients. The production of a validated,
stable, specific FBN with incorporated imaging agent and therapeutic agent (drugs or
siRNAs) by the NANOFOL consortium will have immediate application in all inflammatory
diseases where activated macrophages contribute to the disease process.

Consortium
Coordinator
Pr. Artur CAVACO-PAULO, artur@det.uminho.pt
Universidade do Minho – Portugal
www.nanofol.eu

Partners
 Suanfarma SA – Spain
 Technische Universitaet Graz – Austria
 Nederlandse Organisatie Voor Toegepast Natuurwetenschappelijk Onderzoek –
Netherlands
 Instituto de Biologia Molecular e Celular – Portugal
 Institut National de la Santé et de la Recherche Médicale – France
 Medizinische Universitaet Wien – Austria
 “Aurel Vlaicu” University of Arad – Romania
 Synovo GmbH – Germany
 Institut National de l’Environnement et des risques – France
 Exbio Praha AS – Czech Republic
 ALMA Consulting Group SAS – France
 ALFAMA – Investigacao e Desenvolvimento de Produtos Farmaceuticos, Lda –
Portugal

The research leading to these results has received funding from the European Union
Seventh Framework Programme (FP7/2007-2013) under grant agreement n° NMP4-LA-2009-228827 NANOFOL.

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