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Nanomedicine upscaling for early clinical phases of multimodal cancer therapy

Project description

DEENESFRITPL

Novel nanomedicine for pancreatic cancer

Pancreatic cancer is considered one of the most aggressive types of cancer, often remaining undetected in its early stages due to a lack of specific symptoms. It is characterised by overall poor prognosis, low survival rate, and limited treatment options. To offer treatment alternatives to patients, the EU-funded NoCanTher project aims to develop nanoparticles that are functionalised to target pancreatic cancer cells and deliver an anticancer drug. Researchers will bring this nanoformulation forward for clinical development, which includes scaling up production under certified conditions and optimising various parameters for use in patients.

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).

Fields of science

Programme(s)

Topic(s)

Call for proposal

H2020-NMP-2014-2015

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Sub call

H2020-NMP-2015-two-stage

Funding Scheme

RIA - Research and Innovation action

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
Links
Other funding
€ 0,00

Participants (12)

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Last update: 13 January 2023

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Permalink: https://cordis.europa.eu/project/id/685795

European Union, 2023