financing under the call “Fabbrica intelligente, Agrifood e Scienze della vita”, pursuant to CAPO II of Ministerial Decree 05/03/2018 and subsequent DD 27/09/2018, for the development of the project entitled: “Sviluppo e validazione preclinica di un trattamento TERANOSTICO per il tumore del melanoma basato sull’impiego di cellule del sistema immunitario, T Cells, rinforzate tramite loading con nanoparticelle magnetiche che consentano il delivering di farmaci specifici, l’applicazione di ipertermia localizzata, e una diagnostica MRI avanzata” – active.

The project is born from a basic research, started about ten years ago, that has got a continuous improvement over time and it is in its final point today. For this reason a very relevant disease model, as the melanoma, that is an excellent example of solid tumour, for which the current treatments are not resolutive unfortunately. The concept is based on the use of a cells of the immune system, the T-cell that is extracted from the patient suffering from the disease, then it is selected to be activated with a specific antigen for the disease and finally loaded with a magnetite-based ferrofluid, that internally can take even a specific drug.

The system is identified with the concept of “TROYAN HORSE”, since the T-cell hides itself thanks to its total compatibility with the receiving immune system and bring along, in addition to its inherent contrast capacity to tumour cells, even a heat source and a specific drug.

The advantages are multiple and clear:

1. The treatment is autologous and is based on the modification of cells extracted by the patient and then re-injected in human body systemically;
2. No rejection from immune system and no uptake from reticulo-endothelial system are observed;
3. The specificity of the targeting, due to the natural mechanism of T-cell is much higher than all the other targeting mechanisms known, reaching values even of 70% depending on the functionalization of the surface of the T-cell;
4. The product has no toxicity and no side-effects in the previous tests;
5. The drug taken from the nanostructured carrier, embedded by the T-cell, can be released in the site of the disease, avoiding the side-effects and assuming administration at low doses;
6. The T-cell loaded with magnetite, since it is a MRI contrast agent (t2 type), can be employed even in early diagnosis and can aim metastasis in early stage as possible target;

The project includes even the development of two equipment useful for the goal of the project.

The first equipment is employed in the preparation in semiautomatic/automatic mode of the cells of the immune system in terms of selection, amplification and loading of the drug:  it consists in an incubator in which the culture media and the cells are handled in automatic mode until their final retrieval

Instead the second equipment is necessary for the induction of localized hyperthermia once the functionalized and reinforced T-cell reached the tumour site. It consists in an antenna of radio frequency in the range of 350-500 kHz able to excite the magnetic ferrofluid and produce heat. Thanks to the combined effect of the T-cell (immunological action), the localized hyperthermia (physical action of the temperature) and the drug released in situ (chemotherapeutic action), an autologous treatment of minimum invasiveness and very high specificity is carried out.

The presence of these two equipment, both portable, makes this treatment accessible even to not specialized hospital units, indeed the automatic incubator is a mini-CELL FACTORY that can be placed in every hospital facility, and the RF antenna is designed to be applied locally without using the bulky total body equipment.

Find out the progress of the project SVATT