Objective
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
Fields of science
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
3584 CX Utrecht
Netherlands
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Participants (12)
Legal entity established in a non-associated third country that is not eligible for funding under Article 10 of the Regulation (EU) No 1290/2013 laying down the rules for participation and dissemination in Horizon 2020.
Not active in the Specific Grant Agreement of the project
V6T1Z1 Vancouver
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151 85 Sodertaelje
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2845 Niel
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
7034 Trondheim
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D02 CX56 Dublin 2
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1085 Budapest
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
1125 Budapest
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
69978 Tel Aviv
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54180 Houdemont
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
17177 Stockholm
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20014 San Sebastian
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66386 St Ingbert
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.