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Nanomedicine upscaling for early clinical phases of multimodal cancer therapy

Periodic Reporting for period 2 - NoCanTher (Nanomedicine upscaling for early clinical phases of multimodal cancer therapy)

Reporting period: 2017-10-01 to 2019-03-31

The NoCanTher consortium plans to test in humans a new therapy for pancreatic cancer based on magnetic nanoparticles. The disease addressed in this project has a very bad prognosis, particularly, the survival rate after 5 years (< 5%) has not changed over the last 30 years, despite tremendous efforts at the preclinical and clinical stage.
Worldwide in 2012 there were 338,000 new cases of pancreatic cancer and 331,000 associated deaths. Currently, surgery is the one curative treatment for PDAC (Pancreatic Ductal AdenoCarcinoma, a type of pancreatic cancer) but only a minority of patients present with potentially operable disease (10–20%). Therefore, there is an urgent need to develop effective treatments for this disease, and those based on nanotechnology might solve some of the problems faced with this disease.

Our approach is based on magnetic hyperthermia, where magnetic nanoparticles placed in the tumor are exposed to an alternating magnetic field (AMF) leading to an increase of the temperature of the particles and therefore the tumoral area. This process induces the death of the tumoral cells mainly.
Thus, to test this approach in humans, we need to meet the following objectives:

- Up-scaling under Certified Conditions.
The objective is to provide magnetic nanoparticles with the required properties for the therapeutic system exploited in this project, which is based on magnetic hyperthermia. These particles should be produced in a scalable manner and with the required certification to get the approval for a clinical study.

- Preclinical assessment for the elaboration of the IMDD.
This objective aims to collect information on the nanoparticles regarding their efficacy and safety. Thus, the particles are studied in different animal models, biodistribution and toxicity studies, including the required regulatory toxicity studies. All this information will be used to prepare a Dossier that will allow us to enter a clinical study.

- Clinical Study implementation.

Once we have Clinical Study Authorisation, we aim to run the clinical study using our therapeutic approach testing both the nanoparticles and a device developed in the Project that produces an alternating magnetic field (AMF), which is required to induce hyperthermia with the nanoparticles. The protocol for this study will be designed based on the efficacy and toxicity results obtained in the preclinical assessment.

The NoCanTher consortium counts on the involvement of 11 institutions from three different sectors (Academia, industrial, clinical) and five different countries (Spain, France, Germany, UK, and Ireland).
Since the beginning of the Project the consortium has been focused on the large scale production and assessment of nanoparticles. These must be prepared on not only on a large scale but importantly under certified conditions. A production line has been created specifically dedicated to this and has involved the work of two Industrial partners from two different countries. Knowledge has been transferred assisted by the Academic partners using their expertise of these types of therapeutics –a truly cross-sectoral approach. For the other part of the therapy, an AMF generator has been developed , which must fulfil the strict regulation to be used in the clinic, again the consortium has worked together to achieve these goals. Thus, the nanoparticles are produced under the required regulation and AMF generators are ready to be delivered to the clinical sites –a huge milestone for the Project.

Meanwhile, the preclinical teams across 3 sites have been collecting information on the nanoparticles regarding their efficacy and safety. A special pre-clinical version of the AMF generator has been used in order to assist the translation to the clinical setting. Thus, the particles are studied in different animal models, biodistribution and toxicity studies, including the required regulatory toxicity studies. The safety of the nanoparticles and device has also been thoroughly studied, with work towards the industrial sustainability of the process.

All of this information together with the certified production methods will allow us to apply for the clinical trial authorisation, which will permit us to start a clinical study foreseen in the next stage of the Project.

To spread the word of what the consortium hopes to achieve NoCanTher has been represented at multiple events across Europe, communicating and disseminating the result and aims of the project, reaching out to the general public, researchers, clinicians and stakeholders.
This approach is quite novel and the combination of the two medical devices developed in the consortium have not been employed for the treatment of pancreatic cancer. The challenges ahead are diverse, but we expect to report an effective therapy against pancreatic cancer that can be implemented in hospitals at a moderate cost. Thus, we hope that citizens along Europe will benefit from this innovative therapeutic approach, improving the survival rate and reducing the pain associated with the disease.
NoCanTher at the Spanish event NanoWorld Cancer Day hosted at Vall D’Hebron Institute of Oncology
The NoCanTher GLP lab based at IMDEA Nanociencia Madrid