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Ground breaking 3D cell culture platform to eliminate animal testing in pharmaceuticals

Periodic Reporting for period 1 - DifMATRIX (Ground breaking 3D cell culture platform to eliminate animal testing in pharmaceuticals)

Reporting period: 2018-03-01 to 2018-08-31

85% of early clinical trials currently fail despite successful preclinical in vitro testing. In the case of clinical cancer trials, it is less than 8%. The main reason for such low success rates is that currently used in vitro 2D cell cultures do not mimic living body environment. As a consequence, animal testing continues to be widespread despite the associated cost and strong ethical concerns it raises.
InoCure is addressing this problem with the DifMATRIX - a unique 3D scaffolding platform with drug delivery embedded system, for cell culture. DifMATRIX enables to simulate natural cell phenotype (in vivo) in the in vitro environment.
It redefines in vitro preclinical testing standards, significantly improving preclinical-to-clinical translation efficiency and provide an alternative to animal testing models. The expected impact of the project is to eliminate the animal testing phase from the drug development process.
The goal of the Feasibility Study was to evaluate the legal, economic and technical viability of introducing DifMatrix to the market and to elaborate the innovation business plan for these actions.
We have improved InoMATRIX, the existing product of Inocure, by combination with active drug delivery systems prepared by core/shell electrospinning – DifMATRIX.
DifMATRIX has been tested for release quality, bio-compatibility and production stability. The fibers were showed to successfully incorporate model molecules, proteins and small molecules (e.g. differentiation agents). The technology was also carefully tested for production stability. The release experiments show that the technology is prepared for manufacturing.
The market research of currently available cell culture systems has revealed high demand on new 3D cell culture platform. Also, market size, its volume, and growth factor, as well as competing products of DifMATRIX have been identified. The output of Freedom-to-Operate analysis allowed to develop the intellectual property rights (IPR) strategy. Based on the conducted Feasibility Study, DifMATRIX has sufficient technological, economic and practical viability to go to the Phase 2 stage.
The outcome of the project will be a 3D DifMATRIX cell culture platform for pre-clinical testing of new drug candidates. Our solution aims to eliminate the animal testing phase from the drug development process, saving animals’ lives and reducing cost of the preclinical phase.
Fiber Morphology of DifMATRIX Morphology Selection plate kits