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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

Ziel

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.

Wissenschaftliches Gebiet

Programm/Programme

Thema/Themen

Aufforderung zur Vorschlagseinreichung

FP7-HEALTH-2013-INNOVATION-1
Andere Projekte für diesen Aufruf anzeigen

Finanzierungsplan

CP-FP - Small or medium-scale focused research project

Koordinator

INSERM TRANSFERT SA
EU-Beitrag
€ 355 284,16
Adresse
10 RUE D'ORADOUR-SUR-GLANE - PARISANTE CAMPUS
75015 PARIS
Frankreich

Auf der Karte ansehen
Region
Ile-de-France Ile-de-France Paris
Aktivitätstyp
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Kontakt Verwaltung
Florence Chung (Ms.)
Links
Gesamtkosten
Keine Daten

Beteiligte (5)

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Letzte Aktualisierung: 26 Mai 2022

Mein Booklet

Permalink: https://cordis.europa.eu/project/id/602420/de

European Union, 2024