Considered the future of medicine, treating cancer with cell therapy with CAR-T technology is in the sights of several pharmaceutical companies. Despite having already been shown effective, the therapy still presents difficulties to be made available on a large scale due to its high cost. In partnership with the Ribeirão Preto Blood Center, the School of Medicine of Ribeirão Preto (FMRP) and the School of Medicine of the University of São Paulo (FMUSP), Butantan will use all of its 121-year experience of research and manufacture of immunobiologicals to turn the method into a viable and accessible product for public health.
Therapy with CAR-T cells works by collecting cells from the individual's immune system and “reprogramming” them to identify and attack tumors present in the body. The method was developed at the FMRP Center for Cell-based Therapy and has been tested in patients in an experimental and compassionate way - by medical decision, when the cancer is in an advanced stage and there is no alternative treatment. The first patient to receive the therapy entered complete remission of a lymphoma in less than a month.
“Butantan’s mission is to be at the service of life. We have done so with antivenoms, antitoxins, vaccines and, more recently, with monoclonal antibodies. We are now working on this innovative area of advanced cancer therapies, with the aim of making them available in the Brazilian Unified Health System [SUS]. As a biotechnology institute, Butantan must move forward in the sense of incorporating the most modern technologies available to improve the health of the Brazilian people”, says the president of Butantan, Dimas Covas.
According to the hematologist leading the initiative, therapy with CAR-T cells can cost US$ 400,000 in products and another US$ 500,000 in hospital expenses, totaling about US$ 1 million per patient.
Currently, the center at Ribeirão Preto is the only place in Latin America to perform the procedure and has capacity for one patient at a time. Through the partnership with Butantan, two other units will be inaugurated, in São Paulo and in Ribeirão Preto, increasing the capacity to 300 people per year. “The partnership with the Ribeirão Preto Blood Center and USP aims to leverage this technology and make it a real product that is effective and accessible to the patient,” explains Butantan’s Innovation manager, Cristiano Gonçalves, responsible for the Innovation and Tech Licensing Office of the institution.
For the availability of a new drug or therapy on a large scale, it is necessary to carry out phase 1, 2 and 3 clinical studies, and submit them to the Brazilian Health Regulatory Agency (ANVISA) for approval. “But before starting this process, it is necessary to have production conditions on an industrial scale, quality methods, good clinical and manufacturing practices”, adds Cristiano. As a national and international reference in the production of biotechnological products on an industrial scale, Butantan will provide all assistance to the research center and enable CAR-T's industrial production.
The institute will work with the Blood Center so that the product meets the quality standards required by Anvisa and is produced in sufficient quantity to enable clinical trials. Butantan will also support the Blood Center so that it can present the regulatory materials necessary for submission and registration to the regulatory agency and also establish partnerships in the area of innovation to incorporate new technologies and treatments.
In addition to the joint structuring of the two units in Ribeirão Preto and São Paulo, technological bases already used by Butantan can be used to expand the manufacture of the new therapy. “Cell therapy has several stages of biotechnology in which Butantan already has a long experience, both from research and production points of view. For example, there is a virus production stage that uses cells and vectors, tools in which we have skills and with which we know how to work very well due to our production activity, that is, biological products”, says Cristiano.
