The Minister of Health, Julio García Comesaña, learned this morning about the construction project for the first Center for the production of advanced therapies in Galicia, scheduled for this year. He did it in the facilities of the former Institute of Orthopedics and the Musculoskeletal Tissue Bank of the USC in Monte de la Condesa, which will house the center and in which the adaptation works have just begun by the winning company, Ecofred . At the event, the head of the health portfolio was accompanied by the rector of the USC, Antonio López Díaz.
Company officials offered details on the duration and phases of execution of the works, fundamentally focused on the installation and conditioning of clean rooms and critical areas of controlled environment as work areas adapted to current regulations for the manufacture of advanced cellular immunotherapies .
In this sense, it is expected that the remodeling works will last approximately four months, adapting the existing 200-square-meter clean room installation to the new size dedicated to the production of advanced cell therapies. The Xunta will invest nearly three million euros in this avant-garde center in the tasks of renovating the clean rooms and the manufacturing support areas (quality control laboratories, cryopreservation rooms, and spaces for auxiliary and administrative), in the acquisition of equipment and in the hiring of highly qualified personnel, in charge of the Public Company of Sanitary Services Galaria.
CAR-T, the most innovative and advanced custom medicine
CAR-T therapies start from T cells. These cells are obtained from the patient’s blood and are genetically modified in the laboratory, adding a chimeric antigen receptor or CAR, to subsequently administer the CAR-T cells to the patient. This means that the immune system of the cancer patient can recover its ability, first to recognize the cancer cell, and then selectively destroy it.
With the start-up of this center, in which drugs for various cell therapies can be produced, the Galician community is at the forefront of research and the production of advanced treatments, whose objective is to address different pathologies of an oncological nature .
In this sense, the Minister of Health pointed out that we are dealing with drugs “with a high clinical and healthcare impact that, in some cases, achieve response rates of 80%”.
During the event, the head of the Xunta health department recalled his gratitude to the University of Santiago de Compostela for its cooperation in this top-level project, which will host both the Galician advanced therapy production center and the future Collaborative Research Unit, in which the staff of the new production center for advanced therapies, research groups from the Galician university system, as well as other health research institutes and organizations, will jointly participate.
It is expected that the Research Unit will be created before the end of the year 2022. Thus, its main objective will be to carry out research projects that allow the development of new cell therapies to subsequently be produced in the production center and, successively, be applied to patients in the public health system.
During the first two years of operation, it is expected to be able to produce between one and two different drugs in clinical trials, which could mean a figure of between 50 and 100 patients treated, taking as a reference the size of the trials developed to date in the rest of the state.
In this regard, the Minister of Health referred to the recent agreement signed between Sergas, Galaria and the Hospital Clínic de Barcelona, a reference in this field, which lays the foundations for developing the first clinical trial of a CAR-T therapy to treat oncohaematological cancers, promoted from the autonomous community. The Hospital Clínico Universitario de Santiago will be the first center where this therapy will be administered, with the idea of extending its use to other Galician care centers.
The results of CAR-T therapy published to date show a great effectiveness of this treatment in oncohaematological patients, with high rates of remission of the disease. Through these therapies, the patient’s immune system can recover, through genetic modification techniques, the ability to selectively recognize and destroy tumor cells.