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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

Objective

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.

Coordinator

INSERM TRANSFERT SA

Address

Rue Watt 7
75013 Paris

France

Activity type

Other

EU Contribution

€ 355 284,16

Administrative Contact

Florence Chung (Ms.)

Participants (5)

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CURAVAC EUROPE SPRL

Belgium

EU Contribution

€ 2 101 840,40

piCHEM Forschungs und Entwicklungsgmbh

Austria

EU Contribution

€ 1 162 000

ACADEMISCH ZIEKENHUIS LEIDEN

Netherlands

EU Contribution

€ 1 061 595,84

AEPODIA SA

Belgium

EU Contribution

€ 779 999,60

UNIVERSITAIR ZIEKENHUIS ANTWERPEN

Belgium

EU Contribution

€ 440 000

Project information

Grant agreement ID: 602420

Status

Closed project

  • Start date

    1 October 2013

  • End date

    30 September 2018

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 538 399,15

  • EU contribution

    € 5 900 720

Coordinated by:

INSERM TRANSFERT SA

France