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Nanomedicine upscaling for early clinical phases of multimodal cancer therapy

Objective

During the last four years the 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. To successfully reach this objective, we will concentrate our efforts in two main group of activities:
• Nanomedicine up-scaling under GMP 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 GMP production line will be optimised and the relevant quality control will be conducted at the different stages of the up-scaling process.
• Clinical trial: NoCanTher will include late preclinical parameter testing to raise a clinical treatment protocol, regulatory assays, as well as the design of the clinical trial and the preparation of the Investigational Medicinal Product Dossier (IMPD).

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

FUNDACION IMDEA NANOCIENCIA

Address

Ciudad Universitaria De Cantoblanco - Calle Faraday 9
28049 Madrid

Spain

Activity type

Research Organisations

EU Contribution

€ 665 000

Participants (11)

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BIOKERALTY RESEARCH INSTITUTE AIE

Spain

EU Contribution

€ 1 302 240

IMMUPHARMA PLC

United Kingdom

EU Contribution

€ 427 820

CHEMICELL GMBH

Germany

EU Contribution

€ 400 000

FUNDACION CENTRO NACIONAL DE INVESTIGACIONES ONCOLOGICAS CARLOS III

Spain

EU Contribution

€ 88 538,36

Universitätsklinikum Jena

Germany

EU Contribution

€ 765 125

RESONANT CIRCUITS LIMITED

United Kingdom

EU Contribution

€ 700 000

FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA

Spain

EU Contribution

€ 549 441,25

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

€ 691 847,50

UNIVERSITE PARIS DIDEROT - PARIS 7

France

EU Contribution

€ 611 000

FUNDACIO PRIVADA INSTITUT D'INVESTIGACIO ONCOLOGICA DE VALL-HEBRON

Spain

EU Contribution

€ 352 287,50

HOSPITAL UNIVERSITARIO DE FUENLABRADA

Spain

EU Contribution

€ 560 479,14

Project information

Grant agreement ID: 685795

Status

Ongoing project

  • Start date

    1 April 2016

  • End date

    31 March 2021

Funded under:

H2020-EU.2.1.2.

  • Overall budget:

    € 7 113 778,75

  • EU contribution

    € 7 113 778,75

Coordinated by:

FUNDACION IMDEA NANOCIENCIA

Spain