Brazil: São Paulo to produce CAR-T Cell gene therapy against cancer

RIO DE JANEIRO, BRAZIL – The state of São Paulo is getting ready to deliver to the Unified Health System (SUS) an innovative treatment in the fight against cancer.

Between June 14 and 20, the new facilities of the Nucleus of Advanced Therapy (Nutera), in Ribeirão Preto, in the state’s countryside, and the Nucleus of Cellular Therapy (Nucel), in São Paulo City were delivered.

The two plants are part of a network that will produce local inputs for the so-called CAR-T Cell, a gene therapy that completely changes the way to win the battle against blood cancer (leukemia, lymphoma, and myeloma).

The entire production, which can cost up to US$1 million with imported inputs, will be worth between 3% and 5% of this amount with the domestic factories.

In all, R$200 million (US$38 million) were invested in constructing the two units, allowing CAR-T cells’ production, development, and storage.

The project involves the Butantan Institute, the blood center (Hemocentro) of Ribeirão Preto, and the University of São Paulo (USP).

Although the factories are already ready, the start of production still depends on authorization from the National Health Regulatory Agency (Anvisa), which should occur soon, according to the president of the Butantan Institute, Dimas Covas.

At the same time, the blood center of Ribeirão Preto is already providing services, but in a reduced form, with one case at a time. As soon as it gets approval from the regulating agency, the capacity is 300 attendances per year.

Dimas Covas, who is a hematologist, explains that the significant reduction in the value of the therapy should occur because the treatment will be able to be done entirely within the centers and made available by SUS, optimizing its high cost.

“We are talking about a therapy developed by the public sector, of research funded by the public sector, with investment from the public sector and, therefore, already with a differential concerning the values involved.

“The projection of costs is around 3% to 5% of what it costs abroad because these studies are all public, developed with public resources, and this is our goal,” says Dimas.

The new facilities include quality control laboratories, cryopreservation rooms, virus production rooms, clean rooms for CAR-T cell production and the preparation of media and solutions, and areas destined for the storage of the final product and the inputs in cryogenic tanks.

THE TREATMENT

CAR-T Cell therapy is innovative because it takes a defense cell from the cancer patient’s own body, modifies it in the laboratory, and returns it to the person’s body with the disease.

This genetic change makes it identify the cancer cells to fight them more precisely without the need for synthetic drugs.

In Brazil, the therapy with CAR-T cells was developed in the Center for Cell Therapy of the School of Medicine of Ribeirão Preto at USP.

The first volunteer from Brazil, who received the experimental treatment two years ago, achieved total remission of an end-stage lymphoma. Other patients who opted for the treatment also had remission.

The genetic treatment is indicated for people in advanced stages of blood cancer who have not responded well to conventional methods, such as chemotherapy and radiotherapy.

With information from Exame