CORDIS
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CORDIS

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Clinical safety, immunogenicity and efficacy of a therapeutic vaccine that combines peptides mimicking antigen receptors on autoimmune B and T cells associated with myasthenia gravis

Clinical safety, immunogenicity and efficacy of a therapeutic vaccine that combines peptides mimicking antigen receptors on autoimmune B and T cells associated with myasthenia gravis

Objectif

The MYASTERIX project will advance a therapeutic vaccine candidate (designated orphan drug) indicated for the autoimmune disease myasthenia gravis (MG) to clinical proof of concept studies. MG is caused by T cell dependent antibodies that bind to and deplete acetylcholine receptors (AChR) at neuromuscular junctions causing muscle weakness by interfering with neuromuscular transmission and junction architecture. The vaccine candidate comprises two synthetic peptides designed to generate antibodies that bind to autoantibodies and T-cell receptors associated with MG. These peptides prevented or improved muscle fatigue in a rat model of MG and increased the remission rate to 75% in pet dogs (compared to 17% natural remission rate in historical controls). In both models, administration of the peptides resulted in reduced titres of anti-AChR antibodies and lower numbers of anti-AChR T-cells, based on the induction of antibodies that bound to the corresponding B and T cell antigen receptors. These results suggest that similar antigen receptor mimetic vaccination approaches could drive autoimmune diseases like MG into long-term remission.
The objectives of the project are to manufacture toxicology and clinical batches of the vaccine human formulation based on already developed and tested standard operating procedures, to carry out stability and regulatory toxicity testing of the GMP product, to conduct phase I and subsequently phase II clinical trials to demonstrate safety, tolerability and proof of mechanism of action/concept of the therapeutic vaccine.
The impact on MG patients will be to offer a targeted therapeutic approach requiring only three injections, bringing significant and lasting improvement or even a cure. MG is a model for many autoimmune diseases and the concept of targeted therapeutic vaccines could lead to a new class of drugs for the treatment of autoimmune diseases more generally, with a significant impact on innovation, competitiveness and society.

Coordinateur

INSERM TRANSFERT SA

Adresse

Rue Watt 7
75013 Paris

France

Type d’activité

Other

Contribution de l’UE

€ 355 284,16

Contact administratif

Florence Chung (Ms.)

Participants (5)

Trier par ordre alphabétique

Trier par contribution de l’UE

Tout développer

CURAVAC EUROPE SPRL

Belgique

Contribution de l’UE

€ 2 101 840,40

piCHEM Forschungs und Entwicklungsgmbh

Autriche

Contribution de l’UE

€ 1 162 000

ACADEMISCH ZIEKENHUIS LEIDEN

Pays-Bas

Contribution de l’UE

€ 1 061 595,84

AEPODIA SA

Belgique

Contribution de l’UE

€ 779 999,60

UNIVERSITAIR ZIEKENHUIS ANTWERPEN

Belgique

Contribution de l’UE

€ 440 000

Informations projet

N° de convention de subvention: 602420

État

Projet clôturé

  • Date de début

    1 Octobre 2013

  • Date de fin

    30 Septembre 2018

Financé au titre de:

FP7-HEALTH

  • Budget total:

    € 7 538 399,15

  • Contribution de l’UE

    € 5 900 720

Coordonné par:

INSERM TRANSFERT SA

France