5 March, 2021
CAR-T ARI-0001 (Advanced Therapies)
CREATIO PARTICIPA EN LA PRODUCCIÓN DE LA TERAPIA AVANZADA CAR-T ARI-0001
The Production and Validation Center for Advanced Therapies of the University of Barcelona, has taken part in the production of viruses that act as vectors for the CAR-T ARI-0001 drug, approved by the Spanish Agency of Medicines and Medical Devices (AEMPS) and carried out by the Hospital Clínic de Barcelona. This new therapy intends to treat acute lymphoblastic leukaemia in those cases that feature resistance to classic treatments.
CAR-T ARI-0001 is a chimeric antigen receptor T-cell treatment, a type of cell and genic therapy in which the patient becomes his or her own donor thanks to the genetic modification of his/her lymphocytes. This is the first treatment of this kind to be fully developed in Spain, and the first of its type to be approved of by Spain, through the exceptional authorization for its use by AEMPS.
The genetic modification of the patient’s own lymphocytes is a critical process in the functioning of CAR-T therapies. It is carried out using a virus-based intermediate product which confers lymphocytes the specific ability to attack cancer cells. Regarding the production of this virus in the case of CAR-T ARI-0001, the director of Creatio, Josep M. Canals, says that “it was carried out following protocols from Hospital Clínic at the Creatio facilities, following high quality conditions and good manufacturing practices (GMP), certified by the AEMPS”.
The leader of the project, Manel Juan, also head of the Immunology Department at the Biomedical Diagnostic Centre (CBD) of Hospital Clínic and lecturer at the Department of Biomedicine, highlighted that “the GMP production allowed us to credit the production of this intermediate product, but the application of these GMP rules guaranteed us the quality and reproducibility of this intermediate product, which has been key for the CAR-T ARI-0001 cell product”.
Since 2017, Creatio has produced the GMP condition viruses for the Hospital Clínic de Barcelona. At the moment, Creatio is producing viral particles that are distributed to four hospital centers in Spain: Hospital Clínic, Hospital de Sant Pau i la Santa Creu (Barcelona), Clinica Universitaria de Navarra and Hospital La Paz in Madrid. These viruses will be used to produce new CAR-Ts as advanced drugs for patients with haematological pathologies.
Acute lymphoblastic leukaemia (ALL) is one of the four main types of leukaemia and is featured by an excessive production of lymphocytes, or white blood cells, immature, that are quickly multiplied and move to normal cells in the bone marrow. Although many of the cases achieve a full remission with chemotherapy or a bone marrow transplant, between 10 % and 15% of patients die due to treatment resistance, due to its toxicity or relapse. Results of the trial show that CAR-T ARI-0001 produces a complete response in more than 70% of the patients, which means there is no residual disease left.
Link to video: Creatio takes part in the production of CAR-T ARI-0001 advanced therapy