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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - OPTIMIsE (Commercial feasibility of the Novio-PlainGel: a novel synthetic, reversible thermosensitive, biomimetic hydrogel for organoid-based precision medicine)

Teaser

Summary

A common challenge of cancer treatment is a lack of effective therapies. For example, there is no adequate cure for pancreatic cancer and the survival rate is extremely low. The use of organoids is considered to be the solution to accelerate the development of new therapies for pancreatic cancer.
The culturing of organoids for clinical purposes, however, faces many issues. The most critical one is the animal origin of most commonly used matrices. This leads to batch-to-batch variability resulting in inconsistencies in test results. It also means that clinical applications are impossible. In a nutshell it means that a non-animal derived, synthetic matrix is indispensable for future organoid culturing.
Noviocell will build upon its synthetic polyisocyanopeptide hydrogels and develop them into easy-to-use solutions for clinical puposes. Because Noviocellâ€™s gel is synthetic and not of animal origin, the experiments lead to reproducible results. Furthermore, the gel mimics the natural environment of cells and can be adapted to the requirements needed for organoid growth. The gel is thermoreversible and as a consequence it is easy to recover cells and organoids.

Pancreatic tumor organoids grown in Novio-PlainGel retain a high degree of cell viability and tumor marker expression. Bioactive molecules that are essential for differentiation and optimal growth were identified. ECM and growth factors in combination with a specific culture medium is expected to improve the growth and differentiation of pancreatic organoids.

Market analysis revealed that the 3D cell culture market is a growing market. No major competition is expected due to the unique selling points of Novio-PlainGel and the focus on the oncology market with great future potential. The 3D cell culture market is worth â‚¬433 million in 2015, estimated to reach â‚¬1.5 billion by 2024 with a CAGR of 14.8%. Scaffold-based technologies account for a revenue share of over 40%.

FTO, IP and regulatory analysis revealed that no IP is likely to be infringed. New IP will be generated by modifying Novio-PlainGel for clinical applications. For the diagnostic market, ISO 13485 and CE certification needs to be received and the hydrogel should be produced following GMP regulations.
Based on the results of this study, we conclude that Novio-PlainGel has an enormous potential to become the state of the art for organoid culture to develop disease specific organoids as excellent diagnostic products for clinical applications.

Work performed

During the period covered by the project, a fully comprehensive technical report was produced in which different topics were analysed.
A complete market study and competitive analysis was performed from which is concluded that the 3D cell culture market is a growing market. No major competition is expected due to the unique selling points of Novio-PlainGel. Furthermore, the focus on the oncology market gives a great future potential. The technical feasibility has indeed proven that pancreatic tumor organoids can grow in Novio-PlainGel with a high degree of cell viability and tumor marker expression. We expect that modifications of the gel with respect to stiffness, and bioactive molecules will further improve organoid growth and differentiation. The bioactive factors necessary for optimal growth and differentiation of the pancreatic organoids have been identified. FTO analysis revealed no IP is likely to be infringed, either directly or in the near future. In order to enter the diagnostic market, ISO 13485 and CE certification needs to be obtained. Based on this feasibility project, we have concluded the business idea is feasible and has commercial viability. The business plan has been updated on market information, FTO and IP strategy and road maps for product development, funding and commercialization have been developed.

Final results

The potential of 3D cell culturing is evident: never before have we been able to assess the complexity of (human) biology in such a detailed manner. Recent highlights include brain, liver and disease-specific organoids. These will contribute to our understanding of health and disease as well as identification of new therapeutic targets and biomarkers and personalized medicine. Noviocell BV aims to make organoids suitable for diagnostic applications and provide unique solutions for regenerative medicine. Organoid based disease models will improve understanding of many diseases. Increasing number of patients will benefit from personalized medicine approach as more organoid methods become available. Changes in pharma pipelines will reduce use of laboratory test animals. Enhanced patient stratification protocols will lead to an increased quality-of-life (less toxic treatments with higher efficacy) and quantity of life. Patient-derived-organoid models will give a good representation of the actual effectiveness of certain drugs, and will therefore lead to a new approach to personalized medicine. Reduced costs of healthcare, for example, the average lost productivity cost per cancer death was â‚¬219.241, by increasing the quantity-of-life, this number can be substantially reduced. Moreover, If organoids could cut preclinical costs by half, that would mean â‚¬375 million in savings per drug. With pancreatic organoids in particular, new possible treatments and therapies can be targeted and evaluated.