ISOS is designed to treat chronic diseases requiring lengthy treatments.
The encapsulated GEB populations produce the therapeutic molecules "on demand", stimulated by the signals of the pathological environment within the patient, i.e., inflammation and/or reactive oxygen species. Bacteria populations interact among them to maintain a dynamic equilibrium of the GEB species and to guarantee the survival of the drug-producing GEB as long as the disease persists.
The GEB ecosystem is designed in such a way that bacteria cannot survive outside of the encapsulating biomaterial, to meet future biosafety and regulatory requirements. Currently, there are no GEB ecosystems for complex disease treatments. The design and the configuration of the GEB ecosystem will be personalized for each patient, and it will be done using in-silico tools and synthetic biology.
ISOS will establish the principles of a new generation of therapeutic products that will use recombinant probiotic bacteria strains libraries for personalized treatments with rigorous control of local drug production and efficient delivery based on dynamic variation of pathological signals.
Millions of people are affected by chronic diseases and need continuous and controlled delivery of drugs and therapeutic molecules. In 2021, in the EU, 32.9% of male and 37.4% of female population was affected by at least one chronic disease, peaking at 74.0% among over 85y.o. people. In the USA, 60% of adult Americans have at least one chronic disease. More than 70% of all deaths are caused by one or more of 5 chronic diseases: heart, cancer, stroke, chronic obstructive pulmonary disease, diabetes (2021 data) while treatment of the 7 most common chronic diseases will cost the USA economy $2 trillion annually by 2030.
Unfortunately, to-day, the ideal treatment for most of these diseases - in situ very precise introduction of the therapeutic molecules - is restricted to an extremely low number of cases. Additionally, many drugs have unacceptable side effects in the healthy tissues. These are intensified because of the lack of feedback and adaptation mechanisms of the drug concentration.
Long-term repetitive doses of treatments cause adverse reactions to the social and economic side. In wAMD, the wet form of age-related macular degeneration, patients receive repetitive intraocular injections of anti-VEGF with discomfort, strong side effects and enormous socio-economic costs.