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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-BHC-2018-2020

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Sub call

H2020-SC1-2018-Single-Stage-RTD

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Net EU contribution
€ 2 363 251,25
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (12)

International partner

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.

UNIVERSITY OF BRITISH COLUMBIA

Not active in the Specific Grant Agreement of the project

Canada
Address
Agronomy Road 102-6190
V6T1Z1 Vancouver

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Activity type
Higher or Secondary Education Establishments
ASTRAZENECA AB
Sweden
Net EU contribution
€ 927 500,00
Address
Vastra Maelarhamnen
151 85 Sodertaelje

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
ETHERNA IMMUNOTHERAPIES
Belgium
Net EU contribution
€ 5 229 000,00
Address
Galileilaan 19
2845 Niel

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Vlaams Gewest Prov. Antwerpen Arr. Antwerpen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
SINTEF AS
Norway
Net EU contribution
€ 1 153 906,25
Address
Strindvegen 4
7034 Trondheim

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Region
Norge Trøndelag Trøndelag
Activity type
Research Organisations
Non-EU contribution
€ 0,00
THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD, OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN
Ireland
Net EU contribution
€ 755 805,00
Address
College Green Trinity College
D02 CX56 Dublin 2

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Region
Ireland Eastern and Midland Dublin
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
SEMMELWEIS EGYETEM
Hungary
Net EU contribution
€ 586 750,00
Address
Ulloi Utca 26
1085 Budapest

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Region
Közép-Magyarország Budapest Budapest
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

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.

SEROSCIENCE KUTATO FEJLESZTO ES KERESKEDELMI KORLATOLT FELELOSSEGU TARSASAG
Hungary
Net EU contribution
€ 100 625,00
Address
Lorant Utca 10 B Ep Fszt 2
1125 Budapest

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Közép-Magyarország Budapest Budapest
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
TEL AVIV UNIVERSITY
Israel
Net EU contribution
€ 1 037 000,00
Non-EU contribution
€ 0,00
CYBERNANO
France
Net EU contribution
€ 339 625,00
Address
50 Rue Des Sources
54180 Houdemont

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Grand Est Lorraine Meurthe-et-Moselle
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
KAROLINSKA INSTITUTET
Sweden
Net EU contribution
€ 690 000,00
Address
Nobels Vag 5
17177 Stockholm

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
FUNDACION CIDETEC
Spain
Net EU contribution
€ 1 089 750,00
Address
Paseo Miramon 196 Parque Tecnologico De Miramon
20014 San Sebastian

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Region
Noreste País Vasco Gipuzkoa
Activity type
Research Organisations
Non-EU contribution
€ 0,00
EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH
Germany
Net EU contribution
€ 658 125,00
Address
Heinrich-hertz-allee 1
66386 St Ingbert

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Saarland Saarland Saarpfalz-Kreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00