VES4YOU, a novel bio-nanotechnology: extracellular vesicles from a natural source

Safe, efficient and specific nano-delivery systems are increasingly needed for precision and regenerative medicine and targeted therapies (e.g. anticancer and antimicrobial therapies), as well as for  the cosmetic and nutraceutical sectors’ applications. Despite the appreciable success of synthetic nanovectors, like for example liposomes, their clinical and market application is hampered by some limitations: • large scale production, • low cost production • intrinsic toxicity • limited cellular uptake • limited consumer acceptance. Delivery systems based on extracellular vesicles (EVs) can overcome these limitations. Cells communicate with each other and respond to a variety of stimuli by secreting extracellular vesicles, which are complex structures of nanometric dimensions, bounded by a biomembrane and containing bioactive molecules. EVs have recently been described as important cellular products to mediate different physiological processes or influence various pathological conditions. EVs are also means of communication between different species and have been identified in all living organisms. In addition to mammalian cells, there are some other bioresources studied for making EVs, including bacteria, cow's milk and plants; some of these have been studied for therapeutic or healthcare applications. The exploitation of the biotechnological potential of EVs as vectors of bioactive compounds for different applications is of growing interest. The growth in this field is demonstrated by the surge in recent years in the number of publications, patents and clinical studies related to EVs. A disadvantage limiting progress in the current research and exploitation of EVs is the typically low yield obtainable from current systems for downstream applications including clinical trials. This makes EVs-based therapeutics still some distance away. This hurdle can be overcome by using a new natural source proposed here which would allow a scalable and continuous production of EVs with increased yield, purity and reproducibility and by responding to the requirements of new circular economy strategy. In the context of our national and extended PCT patents (December 2020) and the H2020-FETOpen VES4US project (www.ves4us.eu), we propose a renewable natural source for the production of EVs with applications for the nanomedicine, cosmetic or nutraceutical sectors. The proposed extracellular vesicles of natural origin have better stability, controlled release and additional multifunctionality compared to synthetic nanotechnologies. This offers formulation advantages in terms of dose / cost, stability and efficiency. A first aspect of the invention is the novel product, i.e. extracellular vesicles (EVs), obtainable from a natural source. The proposed EVs are made available through the combination of novel and state-of-the-art technologies to isolate EVs based on their intrinsic physical properties. A third aspect of the invention is the use of the natural resource-derived EVs as biogenic nanocarriers for the molecular delivery of bioactive molecules.