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

Project information

Grant agreement ID: 602999

Status

Closed project

  • Start date

    1 October 2013

  • End date

    30 September 2017

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 699 473,60

  • EU contribution

    € 5 999 706

Coordinated by:

AFFIRIS AG

Austria

Objective

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.

Coordinator

AFFIRIS AG

Address

Karl Farkas Gasse 22
1030 Wien

Austria

Activity type

Private for-profit entities (excluding Higher or Secondary Education Establishments)

EU Contribution

€ 2 905 925

Administrative Contact

Vera Bürger (Mrs.)

Participants (7)

BIOLUTION GMBH

Austria

EU Contribution

€ 685 011

CHU HOPITAUX DE BORDEAUX

France

EU Contribution

€ 342 712

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 173 503

PROSENEX AMBULATORIUM BETRIEBSGMBH

Austria

EU Contribution

€ 366 012

MEDIZINISCHE UNIVERSITAT INNSBRUCK

Austria

EU Contribution

€ 366 012

FORSCHUNGSZENTRUM JULICH GMBH

Germany

EU Contribution

€ 789 322

CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE

France

EU Contribution

€ 371 209

Project information

Grant agreement ID: 602999

Status

Closed project

  • Start date

    1 October 2013

  • End date

    30 September 2017

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 699 473,60

  • EU contribution

    € 5 999 706

Coordinated by:

AFFIRIS AG

Austria

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