Fiocruz and Caring Cross announce agreement to CAR-T therapy in Brazil and Latin America 

Fiocruz, a foundation from the Brazilian government's Ministry of Health, and  Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to advanced medicinal cures for all patients, everywhere, today announced a collaboration to develop local manufacturing of chimeric antigen receptor (CAR)-T cell and stem cell gene therapies for oncology, infectious, and genetic diseases in Brazil, including CAR-T cell therapies for leukemia, lymphoma, and HIV infection. 

Under the terms of the agreement, Caring Cross will provide technology, materials, and training to the Institute of Technology on Immunobiologicals (Bio-Manguinhos/Fiocruz) for the manufacture of CAR-T cell therapies and lentiviral vectors aimed for clinical development and approval. The initial phase of the program will focus on CAR-T cell therapies for leukemia and lymphoma, improved versions of products that are successfully treating patients in selected countries. The collaboration will also advance a therapeutic product for HIV, currently in U.S. clinical trials, designed for the treatment and potential cure of HIV infection, with the expectation of new co-development projects for other diseases.  

CAR-T cell therapies represent a revolutionary treatment, harnessing the body's own immune cells to precisely target and destroy infected cells. However, the transformative potential of CAR-T cell treatments is significantly hindered by their prohibitive costs, exceeding $350,000 per dose. The steep price tag puts these life-saving therapies out of reach for many patients from low and middle-income regions, creating a stark disparity in access to this innovative treatment. With local production, the treatment will be available free of charge to the population, and the cost to the Brazilian public health system would be reduced to 10% of the amount currently charged in Europe and the USA, dropping to US$35,000 per dose. 

Caring Cross has developed manufacturing processes that significantly decreases the material cost of manufacturing CAR-T cell therapy products. This decreased material cost, coupled with point-of-care local manufacturing of patient-specific CAR-T cell products, achieves a product cost that is around one-tenth of the price of currently approved CAR-T cell products in U.S. and Europe. Such a cost is very attractive to public health organizations like Fiocruz which focus upon serving the public health system in Brazil. The agreement with Fiocruz, exclusive to Brazil and Latin America, will not only enable affordable access of CAR-T cell therapies for the Brazilian public health system, but will allow access of critical materials and training needed to manufacture CAR-T cells for other organizations in Brazil and Latin America.   

"Our collaboration with Fiocruz marks a significant step forward in making CAR-T cell therapies more accessible in Brazil and Latin America,” said Boro Dropulić, Ph.D., Executive Director of Caring Cross. “By sharing our knowledge and expertise, this collaboration will establish local manufacturing capabilities for our innovative CAR-T cell manufacturing platform. When integrated with local point-of-care manufacturing, this approach enables us to drastically cut production expenditures and enable access to these therapies at a fraction of the cost compared to the U.S. and Europe. We are hopeful this collaboration will not only make these treatments more affordable but also serve as a global model for improving access to advanced medical therapies.” 

"We are confident to partner with Caring Cross, which possesses deep expertise in the technologies used for CAR-T cell therapy production," stated Dr. Mario Moreira, President of Fiocruz. "This technology transfer empowers Fiocruz to produce these vital CAR-T cells and other therapies in a cost-effective manner and equips our organization with the necessary capabilities to become a central hub for developing and manufacturing advanced medicines, including CAR-T cell therapies, across Latin America.” 

With the transfer of technology, Bio-Manguinhos, the unit of Fiocruz already recognized for its technological capacity for the production of immunobiologicals, including the viral vector vaccine, and biosimilar drugs, will also locally produce the lentiviral vectors intended for the development of CAR-T therapy, as well as being the certifier for advanced posts for the implementation of this therapy in health units throughout Brazil. 

“We are working at the frontier of knowledge, and this is an opportunity for Bio-Manguinhos/Fiocruz to consolidate and expand its competencies in innovation and production of biological products to serve not only the Brazilian public health system but also other Latin American countries,” said Mauricio Zuma, director of Bio-Manguinhos. “This technological agreement with Caring Cross represents an important advancement for the treatment of oncological and infectious diseases and greater access to these treatments for the population.” 

About Caring Cross 

Caring Cross is a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and ensuring access to cures for all patients, everywhere. To enable its mission, Caring Cross is developing technologies and therapeutic candidates to improve the accessibility, affordability, and applicability of advanced medicines like CAR-T therapy and stem cell gene therapy. Caring Cross founded Vector BioMed, a for-profit vector contract development and manufacturing organization (CDMO), specializing in rapid lentiviral vector manufacturing solutions, to provide the industry a source of affordable high-quality GMP Lentiviral vectors. 

About Fiocruz  

The Oswaldo Cruz Foundation (Fiocruz) is the largest biomedical research institution in Latin America, which also produces vaccines and medicines to supply the Unified Health System (SUS, acronym in Portuguese for the Brazilian public health system). Linked to the Brazilian Ministry of Health, the Foundation was created on May 25, 1900 to initially manufacture serums and vaccines against bubonic plague. Since then, the institution has experienced an intense trajectory, which is intertwined with the development of public health in Brazil. Currently, Fiocruz is installed in 10 states, in addition to the Federal District, and has an office in Maputo, capital of Mozambique, Africa, and a future representation office at Addis Ababa, Ethiopia. In addition to the institutes based in Rio de Janeiro, the Foundation maintains units in the Northeast, North, Southeast and South regions of Brazil, and offices in Ceará, Mato Grosso do Sul, Piauí and Rondônia. In total, there are 16 technical-scientific units, focused on teaching, research, innovation, assistance, technological development and extension in the field of health. 

The Institute of Technology on Immunobiologicals (Bio-Manguinhos) is the unit of Fiocruz responsible for research, innovation, technological development and the production of vaccines, diagnostic kits and biopharmaceuticals aimed at meeting the demands of national public health as a priority.