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EXpanding Platforms for Efficacious mRNA Therapeutics

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

Call for proposal

H2020-SC1-2018-Single-Stage-RTD
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 363 251,25

Participants (10)

ASTRAZENECA AB
Sweden
EU contribution
€ 927 500
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ETHERNA IMMUNOTHERAPIES
Belgium
EU contribution
€ 5 229 000
Address
Galileilaan 19
2845 Niel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SINTEF AS
Norway
EU contribution
€ 1 153 906,25
Address
Strindvegen 4
7034 Trondheim
Activity type
Research Organisations
THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD, OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN
Ireland
EU contribution
€ 755 805
Address
College Green
2 Dublin
Activity type
Higher or Secondary Education Establishments
SEMMELWEIS EGYETEM
Hungary
EU contribution
€ 687 375
Address
Ulloi Utca 26
1085 Budapest
Activity type
Higher or Secondary Education Establishments
TEL AVIV UNIVERSITY
Israel
EU contribution
€ 1 037 000
Address
Ramat Aviv
69978 Tel Aviv
Activity type
Higher or Secondary Education Establishments
CYBERNANO
France
EU contribution
€ 339 625
Address
193 Avenue Paul Muller
54600 Villers-les-nancy
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 690 000
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
FUNDACION CIDETEC
Spain
EU contribution
€ 1 089 750
Address
Paseo Miramon 196 Parque Tecnologico De Miramon
20014 San Sebastian
Activity type
Research Organisations
EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH
Germany
EU contribution
€ 658 125
Address
Heinrich-hertz-allee 1
66386 St Ingbert
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)