AMI

Autoimmune diseases are characterized by a deregulation of the immune system leading to damage and dysfunction of specific or multiple organs and tissues. Two inflammatory autoimmune diseases with high prevalence are rheumatoid arthritis (RA) and Systemic Lupus Erythematosus (SLE). For both RA and SLE, and for an increasingly larger number of pathologies, state-of-the-art therapies rely on the use of biologicals. These drugs are very effective on some patients, whereas exhibit no effect on others due to the production of antidrug-antibodies (ADAs). It is critical to develop sensitive and robust assays to diagnose the immunogenic response to biologicals, to identify the best therapeutic strategy, in view of a personalized therapy. Moreover, immunogenicity assessment is crucial in preclinical and clinical phases of development of biologicals, as it is one of the regulatory requirements for approval.

The vision of AMI is a nanoscale platform for the assessment of the immune reaction against biologicals targeted to inflammatory pathologies. RA and SLE will be taken as prototype diseases; anti-TNF-α infliximab and Lupuzor as prototype drugs, respectively.

AMI platform measures ADAs and drug levels in plasma samples and has the following advantages that fill the lags of competing technologies:

1. Label-free, easy to use
2. Rreal time response
3. Ultra-high sensitivity down to sub-pM
4. High specificity
5. Low cost, disposable, readily up scalable
6. Suited for point-of-care.

The translational focus of the research will be implemented by assessing AMI on samples selected from patient bio-banks in a clinical research environment.

AMI breakthroughs will increase life quality and expectancy of patients, improve their condition, and restore their relationships and productivity with important socio-economical fallouts. AMI also addresses the needs of pharmaceutical companies that will be endowed with a tool for high throughput screening of the immunogenicity of biologicals.