EVOLVE: Extracellular Vesicle Nanotechnology for Precision Drug Targeting

Extracellular vesicle (EV)-based nanovectors represent an innovative class of biological carriers for therapeutic delivery. Their endogenous origin, intricate lipid–protein compositions, and inherent capacity for cell–cell communication render them highly biocompatible and well tolerated in vivo. In comparison to conventional synthetic nanocarriers, EV-based systems offer enhanced biological stability, efficient cellular uptake, and minimal immunogenicity, thereby providing a more physiological interface for the transport of therapeutic agents.

 EV-based nanovectors can be loaded with a diverse array of cargoes, including small molecules, peptides, nucleic acids, and other bioactive compounds, through mild physical methods that preserve vesicle integrity and function. This adaptability renders them a promising platform for advanced drug delivery and personalized medicine applications.

 The trademarked platform Minudik®, owned by Adea Biotech S.L. and scientifically developed by researchers at the Biomedical Research Institute of Lleida (IRBLLEIDA) and the School of Medicine of the University of Lleida (UdL) ((Lorca, Laparra et al. 2022, Fernández-Rhodes, Lorca et al. 2024), advances this emerging field through a proprietary EV-based nanocarrier technology. This technology, safeguarded by European and international patents, is derived from by-products of the agri-food industry and is distinguished by specific lipid–protein compositions that impart exceptional biocompatibility, stability, and tissue-targeting capabilities.

 Minudik® nanovectors exhibit:
• excellent oral absorption and stability under digestive conditions, achieving effective systemic bioavailability after oral administration;
• proven ability to cross the blood–brain barrier (BBB);
• persistence in the central nervous system for more than 24 hours, with homogeneous distribution across neural tissues;
• optimal biodistribution and preferential targeting to bone tissue; and
• an outstanding safety profile, with no cytotoxicity or detectable immunogenicity in preclinical models.

 The technology currently reaches Technology Readiness Level (TRL) 6-7, with completed preclinical validation, a scalable production process , and protected intellectual property and registered trademark.

 This project aims to position Minudik® as an enabling platform within the Advanced Therapies and Enabling Technologies (ATET) pillar of PRECISEU, serving as a basis for collaborative research and translational activities with European partners.

The initiative will establish a framework to promote regulatory readiness, interregional cooperation, and clinical validation, while enabling partners to explore new therapeutic applications that benefit from advanced and sustainable delivery technologies.

 Through these joint efforts, the consortium will contribute to accelerating precision therapies targeting the brain and skeleton within a truly European innovation ecosystem.

 To achieve this, IRBLleida intends to build a consortium for the EVOLVE project bringing together:
• pharmaceutical or biotech partners developing active compounds that require advanced delivery systems;
• clinical and translational partners with the capacity to conduct preclinical and early clinical studies validating Minudik®-based formulations; and/or
• additional partners from academia, technology centres, or industry whose expertise in areas such as nanomedicine, formulation analytics, regulatory science, or scale-up could strengthen the consortium multidisciplinary approach and broaden the impact of the project.