Organoid Science announced that two clinical studies of ‘ATORM-C’, an organoid-based intestinal disease regenerative treatment, have been approved for compliance with the Advanced Regenerative Medicine and Advanced Biopharmaceutical Safety and Support Act (hereinafter referred to as the Advanced Regenerative Medicine Act) and will be administered to patients within the year. It is expected that this will be the second clinical entry case after Japan’s Mamoru Watanabe research team.
Organoids, mini organs that mimic human tissue, contain a large amount of tissue-specific adult stem cells and are a future ‘game changer in regenerative medicine’ that have excellent regenerative abilities when transplanted into damaged tissues.
Because of these characteristics, Organoid Science, which can be said to be the frontier of the domestic organoid industry, is preparing to commercialize the world’s first regenerative treatment that can treat incurable diseases based on organoids.
To support this, Organoid Science has been working on a research project to overcome rare diseases from the Ministry of Health and Welfare (Title: Development of intestinal organoid therapeutics for the treatment of regenerative treatment of intractable ulcers caused by Crohn’s disease and entry into clinical trials) and a biohealth investment infrastructure-linked R&D project ( Title: Phase 1 clinical approval of a clinical drug based on intestinal tissue-derived adult stem cells for the development of a treatment for Behcet’s enteritis) Securing the possibility of clinical entry through the establishment of proof-of-concept (PoC) of the technology through a total of 2 cases and commercialization for technology growth I worked hard to get in.
In addition, it was recently selected as the lead organization for the Ministry of Trade, Industry and Energy’s bio-industrial technology development project, and developed an integrated platform for quality verification and characteristic evaluation for full-scale commercialization of organoid regeneration treatments, securing the foundation for industrialization and localization for the commercialization of organoid regeneration treatments. We are focusing on doing this. The combined amount of government support for these three national project projects amounts to 5.6 billion won.
Many companies at home and abroad are developing stem cell-based regenerative treatments, but there are still limitations such as low therapeutic effectiveness due to low differentiation efficiency, differentiation time required for regeneration, and low scalability.
On the other hand, organoid-based regenerative therapy is made up of originally differentiated cells, so the regenerative function begins immediately regardless of the time or degree of differentiation required for differentiation, so the industry predicts that organoids will be able to overcome the limitations of stem cells. do.
According to an official at Organoid Science, the company has its own GMP facility capable of producing cell therapy reagents for clinical trials of organoid-based regenerative therapy for rare and incurable diseases, and has recently obtained a manufacturing license, and is operating the hospital through an agreement with Asan Medical Center in Seoul. Since GMP facilities for advanced biopharmaceuticals for clinical trials are also planned, it is said that there is virtually no shortage of preparations for clinical trials.
CTO (Technical Director) Kyeong-jin Lee, who oversees the development of organoid-based regenerative treatments, said, “I believe that as organoid-based treatments are adopted as a number of government projects, they will become a representative next-generation regenerative treatment that can cure incurable diseases.” He expressed confidence, saying, “As organoids have been approved for clinical research using the grafting method, the era of commercialization of organoids will also be in the near future.”
Source: Pangyo Techno Valley Official Newsroom
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