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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).

Field of science

  • /medical and health sciences/medical biotechnology/nanomedicine
  • /medical and health sciences/clinical medicine/cancer/pancreatic cancer
  • /medical and health sciences/clinical medicine/cancer/breast cancer

Call for proposal

H2020-NMP-2015-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

FUNDACION IMDEA NANOCIENCIA
Address
Ciudad Universitaria De Cantoblanco - Calle Faraday 9
28049 Madrid
Spain
Activity type
Research Organisations
EU contribution
€ 729 696,89

Participants (11)

BIOKERALTY RESEARCH INSTITUTE AIE
Spain
EU contribution
€ 1 494 864,37
Address
Entidad Arcaute 005 Arcaute
01192 Arcaute Alava
Activity type
Other
IMMUPHARMA PLC
United Kingdom
EU contribution
€ 175 250,21
Address
50 Broadway
SW1H 0RG London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CHEMICELL GMBH
Germany
EU contribution
€ 174 171
Address
Eresburgstrasse 22-23
12103 Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
FUNDACION CENTRO NACIONAL DE INVESTIGACIONES ONCOLOGICAS CARLOS III

Participation ended

Spain
EU contribution
€ 88 538,36
Address
Calle Melchor Fernandez Almagro 3
28029 Madrid
Activity type
Research Organisations
Universitätsklinikum Jena
Germany
EU contribution
€ 755 768,05
Address
Bachstraße 18
07743 Jena
Activity type
Higher or Secondary Education Establishments
RESONANT CIRCUITS LIMITED
United Kingdom
EU contribution
€ 888 684,93
Address
Albermale Street The Royal 21
W1S 4BS London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
Spain
EU contribution
€ 630 633,55
Address
Passeig Vall D Hebron 119-129 Edificio De Recerca
08035 Barcelona
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
€ 671 039,54
Address
College Green
2 Dublin
Activity type
Higher or Secondary Education Establishments
UNIVERSITE DE PARIS
France
EU contribution
€ 603 527,89
Address
85 Bd Saint Germain
75006 Paris
Activity type
Higher or Secondary Education Establishments
FUNDACIO PRIVADA INSTITUT D'INVESTIGACIO ONCOLOGICA DE VALL-HEBRON (VHIO)
Spain
EU contribution
€ 347 979,26
Address
Calle Nazaret 115-117
08035 Barcelona
Activity type
Research Organisations
HOSPITAL UNIVERSITARIO DE FUENLABRADA
Spain
EU contribution
€ 553 624,70
Address
Calle Del Molino 2
28942 Fuenlabrada
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)