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Comprehensive in vitro human immune response testing

Country of Origin: Netherlands
Reference Number: TONL20170201001
Publication Date: 13 April 2017

Summary

A Dutch-British joint venture is developing a system of biological and analytical assays that combines novel cell lines, 3D scaffolds and primary cells to deliver an in vitro human cell-based immune system that mimics the in vivo human microenvironment. The company aims at a research cooperation agreement and further collaboration to help validate the system. Furthermore, advice and guidance on the development and application of the system in an industrial setting is wanted.

Description

A Dutch-British company is specialized in biological and analytical preclinical testing of novel drugs and  recently developed a novel in vitro testing platform.  
The introduction of novel drugs, based on new molecular insight, can be recognized as most promising for our healthcare for the coming decades. They are target specific, can be applied as personalized medicine and can be very effective in contrast to generic medicines. However in order to bring these new compounds to the market as new and registered medicines, extensive clinical trials have to be performed. These trials are very time consuming and costly.
The offered in vitro platform is of strategic great value, since it is able to predict the behaviour and noxiousness of potential drugs in the preclinical testing phase of development. The new testing platform makes the whole route of drug development faster and economically feasible and is therefore highly encouraged by regulatory authorities. The need for improved and more rapid and economical trials is urgent since, due to the success of modern molecular biology, more and better solutions and drug targets will be discovered. It is here that the offered platform may claim great impact.
Crucial to the adoption of the offered platform will be to show proof of principle with relevant drug molecules. The company is seeking (bio)pharmaceutical partners (e.g. drug discovery groups, contract research organisations and biosimilars groups) able to provide compounds to validate their model as well as to help validate the offered in vitro system. Ideally this would include marketed compounds and molecules (with associated data) that failed due to immunogenicity.

The company aims at a research cooperation agreement and is open to discuss also other types of agreements. Furthermore, the company is also seeking advice and guidance on the development and application of the testing platform in an industrial setting.
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Advantages and Innovations

A typical immunogenicity study consists of 60 experimental animals per compound to be studied, including tests such as lymph node assays, histopathology, and determination of antigen-specific and auto- antibodies. The offered technology platform robustly predicts the human immune response, offering a viable alternative approach to replace some of these studies and to ensure only the compounds most likely to be safe and efficacious enter regulatory animal studies.

Advantages in a nutshell:
 - Better translation from preclinical studies to humans
 - Reduction in the number of animal tests
 - A more robust and comprehensive immunologic profile: improved safety and risk prediction thus reducing human health hazard risk
 - Drug development can be terminated before costly advanced stages of drug development: reduced investments in non-viable drugs and reduced attrition rate
 - Potential to improve drugs and make non-viable drugs accessible to patients

Stage Of Development

Under development/lab tested

Stage Of Development Comment

The platform is currently under development. More applications and case studies are needed.

Requested partner

Industry and academia and actors in the fields of (bio)pharmaceutical development  (e.g. drug discovery groups, contract research organisations and biosimilars groups).
A concerted research effort and further business development is needed and is based on the open innovation methodology, bringing together collective intelligence of various industries, companies and knowledge organizations.

Cooperation offer ist closed for requests