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Reach α-synuclein-dependent neurodegeneration: clinical development of therapeutic AFFITOPE vaccines for Parkinson’s disease and multisystem atrophy

Objetivo

The goal of SYMPATH is to advance clinical development of therapeutic vaccines targeting α-synuclein (aSyn)-driven neurodegenerative diseases (ND). It addresses Parkinson’s disease (PD) and multiple system atrophy (MSA), two synucleopathies, for which no causal therapy exists. Ultimately, both lead to patient disability and death, which along with patient number (PD) and age of onset (MSA, PD) define their high medical need status.
The proposed programme focuses on 2 vaccine candidates, PD01A and PD03A, delivered by the innovative AFFITOME® technology. Both are peptide-protein conjugate vaccines and first-in-class candidates. They were selected to elicit antibodies neutralizing aSyn but sparing compensatory β-synuclein. Pre-clinical evaluation confirmed their disease-modifying activity in various models. The unprecedented clinical approach, called TANDEM strategy, uses the synergy resulting from applying 2 vaccine candidates in 2 complementary indications linked through their pathology. TANDEM PD/MSA capitalizes on (i) excellent clinical research centres and their associated national/European networks, (ii) platform methods assessing aSyn species as candidate biomarkers and (iii) preliminary clinical experience with PD01A, the first aSyn targeting vaccine ever tested in humans. Its core is formed by 2 phase I studies testing PD01A in MSA and PD03A in PD/MSA. Importantly, trial design (duration, endpoints, vaccine dose and schedule) will ensure collection of initial biomarker data connecting clinical results of PD- and MSA trajectories. SYMPATH defines the logical next development step of both AFFITOPE® vaccine candidates for synucleopathies and generates information/material (biobank) rendering them more amenable to rational drug development. Successful completion of the programme promises reaching aSyn pathology with an active vaccine as a causal therapy for PD/MSA, thus advancing one or both candidates as prime targets for product development and investment.

Convocatoria de propuestas

FP7-HEALTH-2013-INNOVATION-1
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Coordinador

AFFIRIS AG
Dirección
Karl Farkas Gasse 22
1030 Wien
Austria
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Aportación de la UE
€ 2 905 925
Contacto administrativo
Vera Bürger (Mrs.)

Participantes (7)

BIOLUTION GMBH
Austria
Aportación de la UE
€ 685 011
Dirección
Helmut Qualtinger Gasse 2/2
1030 Wien
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contacto administrativo
Iris Grünert (Dr.)
CHU HOPITAUX DE BORDEAUX
Francia
Aportación de la UE
€ 342 712
Dirección
Rue Dubernat 12
33404 Talence
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Jean-Jacques Jalibert (Mr.)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Francia
Aportación de la UE
€ 173 503
Dirección
Rue De Tolbiac 101
75654 Paris
Tipo de actividad
Research Organisations
Contacto administrativo
Muriel Bouas (Mrs.)
PROSENEX AMBULATORIUM BETRIEBSGMBH
Austria
Aportación de la UE
€ 366 012
Dirección
Schottenfeldgasse 45
1070 Wien
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contacto administrativo
Dieter Volc (Dr.)
MEDIZINISCHE UNIVERSITAT INNSBRUCK
Austria
Aportación de la UE
€ 366 012
Dirección
Christoph Probst Platz 1
6020 Innsbruck
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Wolfram Rieneck (Dr.)
FORSCHUNGSZENTRUM JULICH GMBH
Alemania
Aportación de la UE
€ 789 322
Dirección
Wilhelm Johnen Strasse
52428 Julich
Tipo de actividad
Research Organisations
Contacto administrativo
Anke Krüger (Mrs.)
CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE
Francia
Aportación de la UE
€ 371 209
Dirección
Rue Viguerie 2 Hotel Dieu Saint Jacques
31052 Toulouse Cedex 3
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Corinne Joffre (Dr.)