The project
From discovery to remission
A breakthrough technology, an advanced clinical program in humans, validation in animals, and a pipeline leading to Phase 2. Here is how it all fits together.
Our technology
The complementary peptide: a molecular mirror that neutralizes only the responsible autoantibodies, without weakening the rest of the immune system.
Understand the mechanismHuman development
The targeted active therapy against myasthenia gravis (CV-MG). Phase 1b successful through the MYASTERIX consortium; Phase 2 in preparation with CV-MG02.
View the pipelineVeterinary development
The same technology for canine myasthenia gravis · 75% remission in 2.4 months (versus 18% in 24 months with conventional care). CuraVac's Veterinary Unit, led by the same team. Detailed content coming soon.
Discover the Veterinary UnitPipeline
Overview of each program’s status, from research to registration, for both the human and veterinary tracks, with key regulatory milestones highlighted.
Explore the pipeline2013 – 2018
The MYASTERIX consortium
A 5-year European collaborative project that advanced the targeted active therapy (granted orphan drug designation) against myasthenia gravis: clinical safety, immunogenicity, and efficacy.
Supported by the European Commission under the 7th Framework Programme (FP7) — grant agreement No. 602420.
- CuraVac Europe Belgium
- UZA · Antwerp Belgium
- LUMC · Leiden Netherlands
- piCHEM Austria
- Aepodia Belgium
- Inserm Transfert France
Human development
The Phase 1b clinical trial
In 2016, at Antwerp University Hospital (UZA), 24 patients with mild to moderate myasthenia gravis received CV-MG01. This first-in-human proof-of-concept study aimed to measure the safety, tolerability, and immunogenic response of the candidate.
Protocol
Three cohorts of 8 patients. In each, 6 receive the immunization and 2 a placebo. Low dose in the first cohort, then high dose in the next two.
Cohort 1
Low dose
6 immunized · 2 placebo
Cohort 2
High dose
6 immunized · 2 placebo
Cohort 3
High dose
6 immunized · 2 placebo
CV-MG01 Placebo (aluminum hydroxide)
24
patients (UZA, 2016)
4
became asymptomatic
3
remained so > 4 years
Tolerability · excellent profile
Adverse events mostly mild to moderate, mainly injection-site reactions that resolved spontaneously within a few days.
Signs of efficacy
Most patients improved · 4 became asymptomatic, 3 of whom remained so for more than 4 years. The strongest antibody responders are also the most improved.
These results — an excellent tolerability profile together with signs of efficacy — call for a Phase 2 efficacy trial with a more potent formulation, CV-MG02. Efficacy remains to be confirmed in Phase 2.
Key milestones
Phase 1b
successful · safety (UZA, 2018).
EMA · FDA
orphan drug (2009, 2011).
75%
remission in dogs with complementary peptides.
€18 M
in channeled funding.
Next step: the Phase 2 efficacy trial
With CV‑MG02, a more potent formulation, we are now seeking investors to fund this decisive next step in development.