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EU-Förderung (14,9 Mio. €): EXpanding Platforms for Efficacious mRNA Therapeutics Hor09.07.2019 EU-Rahmenprogramm für Forschung und Innovation "Horizont"
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EXpanding Platforms for Efficacious mRNA Therapeutics
The overall objective of EXPERT is to create an off-the-shelf mRNA-delivering nanomedicine platform that is manufactured via a quality-by-design (QbD) approach with precise nanoparticle characterization and specifications that meet the requirements for GMP scaling up and clinical translation. As proof-of-concept we will perform a first-in-man clinical study for an intratumorally administered immunostimulatory mRNA-nanomedicine in cancer patients. The work focuses on the three critical elements of the call “Innovation platforms for advanced therapies of the future” 1. EXPERT investigates mRNAs as therapeutics, which are classified as advanced therapies. 2. By showing proof-of-concept in a clinical trial we aim to meet the technical, industrial and regulatory challenges to develop a mRNA-nanomedicine formulation from bench to bedside. This opens up new treatment possibilities for a large group of cancer patients and paves the way for subsequent formulations strengthening the European advanced therapy R&D. 3. mRNA nanomedicines are a true platform technology. mRNAs are composed of four similar building blocks, resulting in a molecule with predictable qualities. This allows for a platform approach to production, purification, formulation and storage which streamlines the drug development process offering important technological progress in this field. We will encapsulate mRNA into nanocarriers. Thereby, the mRNA is protected and the physicochemical characteristics of the mRNA are overruled by the characteristics of the nanoparticle to enable target cell uptake. We have experience in state-of-the art materials to make mRNA nanomedicines. To address their complexity we will optimize nanoparticle design and manufacture via QbD. We will use microfluidic manufacture as a scalable and reproducible production technology. To characterize and manufacture the mRNA nanomedicines under GMP conditions we will use the EU-ecosystem of designated facilities within EUNCL and NANOP
Geförderte Unternehmen:
| Firmenname | Förderungssumme |
| Astrazeneca AB | 927.500 € |
| Cybernano | 339.625 € |
| Etherna Immunotherapies | 5.431.013 € |
| Eurice European Research AND Project Office GmbH | 658.125 € |
| Fundacion Cidetec | 815.250 € |
| Karolinska Institutet | 773.463 € |
| Semmelweis Egyetem | 687.375 € |
| Seroscience Kutato Fejleszto ES Kereskedelmi kft. | 0,00 € |
| Sintef AS | 1.270.181 € |
| TEL Aviv University | 1.524.500 € |
| The Provost, Fellows Foundation Scholars & the Other Members of Board, of the College of the Holy & Undivided Trinity of Queen Elizabeth Near Dublin | 755.805 € |
| Universitair Medisch Centrum Utrecht | 1.748.500 € |
| University OF British Columbia | 0,00 € |
Quelle: https://cordis.europa.eu/project/id/825828
Diese Bekanntmachung wurde von Englisch nach Deutsch übersetzt. Die Bekanntmachung bezieht sich auf einen vergangenen Zeitpunkt, und spiegelt nicht notwendigerweise den heutigen Stand wider.