This invention provides experimental evidence that it is possible to express therapeutic proteins, through modified lactic acid bacteria taken with the diet, directly inside the body, and that these are capable of reaching the brain.
| Patent title | NON-PATHOGENIC BACTERIA FOR DELIVERY OF PTD-FUSION PROTEINS |
|---|---|
| Thematic area | Health |
| Ownership | Jožef Stefan Institute, ALMA MATER STUDIORUM - UNIVERSITA' DI BOLOGNA |
| Inventors | Elisabetta Ciani, Giulia Candini, Stojanov, Berlec, Stefania Trazzi, Giorgio Medici |
| Licensing status | Available for development agreements, options, licenses, and other valorization agreements. |
| Keywords | Lactic acid bacteria, Protein replacement therapy, Protein transduction domain, Monogenic disorders, Protein secretion |
| Filed on | 09 May 2024 |
The development of effective therapies for rare monogenic diseases, especially neurological ones, represents a significant social challenge. Probiotic agents, such as lactic acid bacteria, are emerging as a possible solution for the oral administration of therapeutic molecules. Although there has been progress in the use of lactic acid bacteria to treat gastrointestinal disorders, their use for neurological pathologies is still in the developmental stage. This is because the therapy requires the proteins produced by lactic acid bacteria to be modified to cross the blood-brain barrier and reach the brain to exert their therapeutic action.
This innovation is based on the use of lactic acid bacteria as small biological factories for the production and secretion of a potential therapeutic agent directly inside the organism. To achieve this goal, L. lactis bacteria have been engineered so that, once ingested, they can produce and release the TATk-GFP protein inside the intestines of mice. Once released into the host organism, this protein can travel through the bloodstream to the brain, crossing the blood-brain barrier due to the presence of the TATk peptide.
i) High therapeutic potential: Restoring the protein function that the body lacks.
ii) Its potential applicability to virtually all types of monogenic diseases and even to other conditions where the introduction of a therapeutic protein agent into the body is necessary.
iii) A method of oral administration, non-invasive for the patient, easily measurable, and easily implementable for long periods, even in pediatric patients.
iv) Low production costs due to the ease of large-scale production of lactic acid bacteria at an industrial level, with significant economic and social benefits, as well as offering access to therapy to a larger number of patients.
v) The therapeutic vehicle: lactic acid bacteria are recognized as safe organisms for food use and are commonly used as probiotics.