CREATIC: new LF MU centre of excellence opens the way to modern therapies for rare diseases
As of 1 January 2024, Faculty of Medicine MU has its own centre of excellence called CREATIC. Its main task will be to pave the way to affordable cell and gene therapy for rare diseases. Exactly one year ago at the time of Advent, the Faculty of Medicine MU learned the great news. With its project for a centre for research, development and production of cell and gene therapies for rare diseases, it had succeeded in a huge international competition. It has thus achieved support from the prestigious Teaming for Excellence call under the Horizon Europe research and innovation programme. Since then, a lot of work has been done and this Christmas we can celebrate for the second time at the Faculty of Medicine.
The main mission of the Central European Advanced Therapy and Immunotherapy Centre (CREATIC) will be to excel in the research, development and manufacture of innovative medicines for advanced therapies, while also finding innovative ways to provide very expensive advanced therapy medicines to patients in need at an affordable price. Two cell therapy drugs have already been developed in the Advanced Cell Immunotherapy Unit (ACIU) laboratories, which have so far been part of the CZECRIN (Czech Clinical Research Infrastructure Network) research infrastructure within the Institute of Pharmacology of the Faculty of Pharmacology of the Medical Faculty of Masaryk University, and which will jointly become part of the new centre of excellence from 1 January. The first is an anti-cancer vaccine for paediatric cancer patients with rare high-risk solid tumours. More than 40 patients have so far been treated with this type of therapy in a clinical trial. Many of them are in long-term remission of the disease. The second drug based on mesenchymal stromal cells is for patients with butterfly wing disease. In the human body, these help repair damaged tissues and direct the exaggerated functions of the immune system. "Both types of medicines allow for very precise and personalised treatment of rare diseases and can be produced on a small scale for a limited number of patients," explains Associate Professor Regina Demlová, who will head the CREATIC centre. "At the same time, their production must take place close to the patients. By linking to collaborating hospitals and the infrastructure for supporting non-commercial clinical research CZECRIN, we are gaining a comprehensive tool in the form of the CREATIC centre to enable patients with rare or previously undiagnosed diseases to have access to modern therapies," adds Demlová.
A major challenge for the CREATIC Centre is to address the availability of advanced therapies for patients with rare diseases, including price regulation and reimbursement mechanisms. A platform is being established within the Centre to update and harmonise regulatory practices based on data-driven analyses. Its goal is to pave the way to a mutually agreed new model that will ensure access to treatment for patients and be sustainable for healthcare systems.
Thanks to funding from the Jan Amos Komenský Operational Programme, Hall C03 of the Bohunice University Campus will be rebuilt for CREATIC over the course of two years. The ACIU laboratories are currently located here. The reconstruction will create almost 1000 m2 of clean GMP space that will stand comparison with the highest world standards. "Clearly the biggest challenge for us will be to ensure uninterrupted operations in the laboratories, which are subject to strict regulatory control, throughout the reconstruction period," says Ondřej Bar, who as Operations Director at CREATIC is responsible for overseeing the coordination of the construction work. The newly built facilities will significantly help to speed up production processes. "This will ensure their safety and state-of-the-art solutions. The entire production process will take place under one roof and under the management of one entity," adds Ondřej Bar.
The new premises will also include four brand new laboratories for gene therapy, which the Faculty of Medicine has no experience with yet. However, as part of the CREATIC teaming project, we are linking up with top European partners - the Fraunhofer Institute - the world's leading organisation for applied research in the field of gene and cell therapies, the University of Leipzig and the University of Copenhagen, who will share their know-how in this area.
One of the pillars of the CREATIC Centre is therefore education. In addition to educational seminars and workshops, the centre's strategy will also include, for example, new study profiles with a focus on advanced therapeutics. "On the premises of the Faculty of Medicine of Masaryk University we are thus building technologically advanced development and production laboratories that will serve excellent researchers of international level for the development and production of cell and gene therapies, enabling the treatment of individual patients or very small groups of patients. The CREATIC Centre is being established as a public research centre and its anchorage within the Faculty of Medicine of Masaryk University combines academic, research and clinical application in close proximity to the patients being treated," summarises Regina Demlová.
