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Nanomedicine upscaling for early clinical phases of multimodal cancer therapy

Objective

This project has been amended in July 2019 to better align the described tasks and timeline with the current status of the project.

The preceding Multifun Consortium (FP7 project Nº. 262943) has developed and validated distinct nanoformulations as therapeutic approach against pancreatic and breast cancer. These nanoformulations are based on magnetic iron oxide nanoparticles (MNP) multifuntionalised with a target peptide and an anticancer chemical drug, allowing for a synergistic therapeutic effect produced by the combination of intracellular drug delivery and magnetic hyperthermia. In particular, some of the designed formulations (patent filed PCT/EP2015/056631) have proven their efficacy, safety and non-toxicicty, in in vitro and in vivo studies, against the mentioned cancers, thus making them promising candidates to produce a novel nanomedicine therapy for cancer.

NoCanTher aims at translating one of these nanoformulations to early clinical development for pancreatic cancer. Particularly, we plan to assess bare nanoparticles (System B) and multifunctional nanoparticles (System A) in advanced preclinical models and run a clinical study with the System B. To successfully reach this objective, we will concentrate our efforts in two main group of activities:

• Nanotherapeutic up-scaling under Certfified conditions: NoCanTher will scale up the manufacturing of the proposed nanoformulation from milligram-scale laboratory synthesis up to multigram-scale production to generate sufficient material for clinical and regulatory assays. To this aim, a certified production line will be optimised and the relevant quality control will be conducted at the different stages of the up-scaling process.
• Clinical Study: NoCanTher will include late preclinical parameter testing to raise a clinical treatment protocol, regulatory assays, as well as the design of the clinical study and the preparation of the Investigational Medicinal Device Dossier (IMDD).

This strategy will allow us to apply for Clinical Study Authorisation (CSA) then, we will carry out a Clinical Study. NoCanTher involves the participation of 11 institutions from three different sectors (academia, industry, clinical) and from five different countries (Ireland, France, Germany, Spain and the UK).

Call for proposal

H2020-NMP-2014-2015

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Sub call

H2020-NMP-2015-two-stage

Coordinator

FUNDACION IMDEA NANOCIENCIA
Net EU contribution
€ 729 696,89
Address
Calle Faraday 9 Ciudad Universitaria De Cantoblanco
28049 Madrid
Spain

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Research Organisations
Non-EU contribution
€ 0,00

Participants (12)

BIOKERALTY RESEARCH INSTITUTE AIE
Spain
Net EU contribution
€ 1 494 864,37
Address
Entidad Arcaute 005 Arcaute
01192 Arcaute Alava

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Region
Noreste País Vasco Araba/Álava
Activity type
Other
Non-EU contribution
€ 0,00
IMMUPHARMA PLC
United Kingdom
Net EU contribution
€ 175 250,21
Address
50 Broadway
SW1H 0RG London

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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
London Inner London — West Westminster
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
CHEMICELL GMBH
Germany
Net EU contribution
€ 174 171,00
Address
Eresburgstrasse 22-23
12103 Berlin

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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
Berlin Berlin Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
FUNDACION SECTOR PUBLICO ESTATAL CENTRO NACIONAL INVESTIGACIONES ONCOLOGICAS CARLOS III

Participation ended

Spain
Net EU contribution
€ 88 538,36
Address
C Melchor Fernandez Almagro 3
28029 Madrid

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Research Organisations
Non-EU contribution
€ 0,00
UNIVERSITATSKLINIKUM JENA
Germany
Net EU contribution
€ 755 768,05
Address
Kastanienstr.1
07747 Jena

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Region
Thüringen Thüringen Jena, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
RESONANT CIRCUITS LIMITED
United Kingdom
Net EU contribution
€ 888 684,93
Address
Albermale Street The Royal 21
W1S 4BS London

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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
London Inner London — West Westminster
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
Spain
Net EU contribution
€ 630 633,55
Address
Passeig Vall D Hebron 119-129 Edificio De Recerca
08035 Barcelona

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Region
Este Cataluña Barcelona
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
€ 671 039,54
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
UNIVERSITE PARIS CITE
France
Net EU contribution
€ 424 494,45
Address
85 Bd Saint Germain
75006 Paris

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Region
Ile-de-France Ile-de-France Paris
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.

CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
Net EU contribution
€ 179 033,44
Address
Rue Michel Ange 3
75794 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
FUNDACIO PRIVADA INSTITUT D'INVESTIGACIO ONCOLOGICA DE VALL-HEBRON (VHIO)
Spain
Net EU contribution
€ 347 979,26
Address
Calle Nazaret 115-117
08035 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Non-EU contribution
€ 0,00
HOSPITAL UNIVERSITARIO DE FUENLABRADA
Spain
Net EU contribution
€ 553 624,70
Address
Calle Del Molino 2
28942 Fuenlabrada

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00