The team of researchers from OncoGen Timișoara involved in the CAR-NK project has recently succeeded in developing CAR-T (chimeric antigen receptor – T cell) and CAR-NK (chimeric antigen receptor – Natural Killer cell) technology. The aim of this project was to develop the latest technologies in the treatment of cancer, with the ultimate goal of applying personalized therapies to patients.
In 2016, the OncoGen Center for Gene and Cell Therapies in Cancer Treatment team won the "Cancer therapy with Natural Killer cells carrying chimeric antigen receptors - CAR-NK" project, financed by the Competitiveness Operational Program 2014-2020, with a budget of about 2 million euros. The project runs until the end of August 2020, in collaboration with the Technical University of Dresden and the Goethe University of Frankfurt.
"The results obtained so far in this project allow us to move to the next phase, namely the production of these genetically modified immune cells, in order to treat patients affected by acute lymphocytic leukemia with B lymphocytes. As soon as possible we will operationalize the production of these personalized vaccines, with that's how we will manage to save a greater number of patients, children and adults, who otherwise lose the fight against this deadly disease".
At the moment, the Timișoara Center has the necessary training and equipment to bring these new therapies to patients. However, to complete the process, it is necessary to meet certain manufacturing conditions, similar to those in the production of vaccines or drugs, imposed by both the European Medicines Agency (EMA) and the National Agency for Medicines and Devices Medical from Romania (ANMDMR).
"The two authorities require the operationalization and GMP (Good Manufacturing Practice) authorization of production units or, in the case of genetic modifications, BSL (Biosecurity Level 2) authorization - a facility that allows you to work with vectors without the risk of contaminating personnel or the environment ", said Prof. Dr. Virgil Păunescu.
Currently, Romanian patients do not have access to such therapies, because their cost, internationally, is between 500,000 and 800,000 dollars per person.
At the end of 2017, the Food and Drug Administration – FDA (United States Drug Agency) approved the marketing of the first personalized therapies for B-lymphocyte acute lymphoblastic leukemia, with spectacular results. About 80% – 90% of the patients suffering from this disease, who have no therapeutic chance left, are cured following the application of this treatment.