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.

Myasterix is a project to test the Clinical safety, immunogenicity and efficacy of a therapeutic vaccine for myasthenia gravis (MG).

CuraVac, owner of the MG therapeutic vaccine, a Designated Orphan Drug, created a consortium of five entities, four companies and one reference University Medical Center for myasthenia gravis, to prepare and conduct phase 1 and phase 2 clinical trial of this new therapeutic approach for autoimmune diseases like MG.

MYASTERIX is a 5-year collaborative research project started in October 2013 and supported by the European Commission under the Health priority of 7th Framework programme.

The science of the project is coordinated by CuraVac who is also the sponsor of the trials. CuraVac Europe is a Belgian SME specialized in therapeutic vaccines for autoimmune diseases.

Around CuraVac, the MYASTERIX project consortium brings together 4 complementary partners: piCHEM, a SME from Austria that has specific expertise in peptide vaccine synthesis/conjugation and GMP accreditation to manufacture vaccines; the Leiden University Medical Center a referral site for myasthenia gravis in the Netherlands; a CRO, Aepodia, a SME from Belgium specialized in organizing and conducting small clinical trials; as well as Inserm Transfert, a technology transfer & management company based in France.

Myasthenia gravis (MG) is a neuromuscular disorder in which functional acetylcholine receptors (AChR) become depleted at neuromuscular junctions due to an antibody-mediated autoimmune attack on the neuromuscular synapse. AChR antibodies can be detected in the serum of ~90% of patients with generalised MG. It is a rare orphan disease with a prevalence of 1.6–2 per 10,000 people and an incidence of 1.2–1.5 per 100,000 people.

Current treatments include symptomatic pharmacotherapy, immunosuppressive medication, immunomodulating therapies and a surgical procedure (thymectomy). Symptomatic pharmacotherapy using acetylcholinesterase inhibitors increases the availability of acetylcholine (ACh) at the neuromuscular junctions. Immunosuppressive medications include prednisone, cyclosporine, azathioprine, mycophenolate mofetil and occasionally cyclophosphamide. Immunomodulating approaches include plasmapheresis and the use of intravenous immunoglobulin (IVIg).

MYASTERIX project is expected to bring a more targeted therapeutic approach with fewer and less severe side effect than the existing therapeutics.

MYASTERIX is a 5-year European Collaborative Project supported by the European Commission under the Health Cooperation Work Programme of the 7th Framework Programme under the Grant Agreement nº 602420.