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EUROSTARS – Spanish SME looking for a partner to carry out preclinical regulatory trials for the development of novel antitumorals based on nanomedicine.

Country of Origin: Spain
Reference Number: RDES20200626001
Publication Date: 26 June 2020

Summary

A Spanish SME, in collaboration with a local University, has been developing an advanced drug delivery system which allows to increase the therapeutic efficacy of chemotherapeutics against Non-Small Cell Lung Cancer (NSCLC). The goal of this Eurostars proposal is to obtain a full-characterized antitumoral product ready to be tested in clinical trials. They are looking for a partner to carry out the preclinical regulatory trials.

Description

Cancer is the second leading cause of death globally and was responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths is due to cancer (WHO). Lung cancer is the most common with, approximately, 18% of these deaths and reaching more than 80% of mortality rate in diagnosed patients. Most of the current antitumoral treatments have many undesired effects, which are commonly associated with high toxicity in healthy tissues, making them unappropriated for sensitive or risky patients

In this scenario, the company, in collaboration with a local university, has been developing an advanced drug delivery system which allows to increase the therapeutic efficacy of chemotherapeutics against Non-Small Cell Lung Cancer (NSCLC).

The innovation developed in this project comes from their specialization in polymers design. Thanks to their platform, they are able to synthesize high range of polymers which can incorporate many functionalities in nanocapsules surface. Tuning the physico-chemical behavior of the polymeric wall, they are also modifying the biological profiles of the nanocapsules. Those ones can be directed to specific organs or tissues in human body, as well as specific organelles inside target cells. For cancer therapy, they have designed a system to exploit the unique biological features of solid tumor in order to selectively fight against it.

In this project, the company wants to demonstrate how this system improves therapeutic effect of FDA-approved chemotherapeutic agents (FDA-approved platinum drugs and Irinotecan), achieving same antitumoral effects with lower drug concentrations. To do so, they want to compare the efficacy and toxicological values of free drugs against encapsulated ones. At the end of the project, they expect to obtain a full-characterized antitumoral product, which will show enhanced therapeutic effect against NSCLC and in total compliance with EMA for regulatory preclinical phase: completed New Drug Application (NDA) and ready to be tested in clinical trials. Once they have protected IP, they will evaluate potential scenarios for technology transfer, targeting big pharma companies

The company is preparing a proposal for an Eurostars call. They will be the project leaders and a local university will take part as a subcontracted entity. A new full-fledged partner will be included in the consortium in order to carry out with previously described trials. The partner will manage its own budget to accomplish the objectives. The partner must follow Eurostars program selection criteria and be located in the countries participants of the programme: Austria, Bulgaria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, South Africa, South Korea, Sweden, Switzerland, Turkey or United Kingdom.

The deadline for the call is the 3rd September 2020.
The expressing of interest for participation is 20th July 2020.
The project will last between 2 and 3 years, starting on May 2021

Advantages and Innovations

From last 10 years, the company has developed a technological platform which has been satisfactorily tested in the development of novel nanomedicines. It allows the encapsulation and controlled delivery of different types of drugs, reducing side-effects and enhancing their therapeutic index.

In the field of oncology, these novel products have been evaluated in vivo in terms of biodistribution and toxicity, exhibiting high accumulation in solid tumor zones with non-toxic effects associated to the nanocarrier. In vivo efficacy assays have been also performed in order to elucidate its potential clinical application, offering promising results in ectopic and orthotopic models of Lung Cancer, both reducing tumor growth.

This technology of encapsulation is based on biodegradable and biocompatible polyurethane chemistry, providing the ability to create smart, robust and multifunctionalized nanocapsules. These nanocapsules promote specific drug accumulation in solid tumor locations, by selective surface cationization in acidic pH, as well as preferential release in highly reductive media, as described inside tumor cells by their high L-glutathione concentration.

At the end, an homogeneous water-based dispersion is obtained and can be administered through intravenous injections. Using self-ordered and auto-emulsifiable polymers they also avoid the use of any external surfactant, that could produce undesired allergic effects for the production or/and sanitary personnel.

The synthesis of nanocapsules is based on a two-steps one-pot process is fully scalable at industrial level. Following company innovative line, the synthetic pathway possesses low-energetic demand tasks and zero residues.

Stage Of Development

Proposal under development

Stage Of Development Comment

They have already tested the in vivo efficacy of their system with hydrophobic experimental drug derived from prodigiosin, showing inhibition of tumor growth. Both pharmacokinetics and toxicological trials have yield very good results. 

Under the framework of the European project, they want to apply this system to encapsulation of platinum-derived drugs and Irinotecan, first-line treatments against NSCLC. Their aim is to complete the regulatory preclinical phase, obtaining the approval to start with clinical trials.

Requested partner

They are looking for potential full-fledged partners that can carry out with preclinical regulatory trials to accomplish with NDA requirements. The partner must be experienced in in vivo tumoral models of two types of mammalian (rodents and non-rodents). They will follow the EMA regulations for non-clinical evaluation for anticancer pharmaceuticals (ICH S9), so the partner must work under GLP conditions. Non-required GLP trials of ICH S9 will be carried out in the local university.

As a full-fledged consortium partner, the partner will also participate in project decisions and contributing in proposal elaboration.

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