Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduce the cost of these treatments in the United States and Europe.
Caring Cross and Fundacao Oswaldo Cruz (Fiocruz)—a foundation funded by the Brazilian Ministry of Health—plan to develop and manufacture the medicines at a fraction of their cost in the U.S.
Co-founded by cell and gene therapy manufacturing trailblazers Boro Dropulic, Ph.D. and Rimas Orentas, Caring Cross’ mission is to organize and support a community of healthcare professionals, scientists, engineers, advocates and business leaders to accelerate the development of advanced medicines and make them available for all patients around the world.
The program with Brazil is the first of its kind anywhere in the world, Dropulic and Orentas said in an interview with Fierce Pharma.
“We’re pioneering something quite new in terms of teaching an organization, that is directly linked to the Ministry of Health, how to manufacture CAR-T cells and the vectors themselves,” said Dropulic, the executive director of Caring Cross. “We will start first in Rio de Janeiro at the Fiocruz campus—in collaboration with INCA, which is their equivalent of the NCI (National Cancer Institute)—to run clinical trials for leukemia and lymphoma.”
Dropulic knows the drill. He founded Lentigen, which developed the lentiviral vector used by Novartis to produce the first FDA-approved cell therapy product, Kymriah, in 2017. Dropulic directed Lentigen’s CDMO business model before launching Caring Cross in 2021.
The effort in Brazil will include the development of a product for HIV, which is currently in clinical trials in the U.S. A candidate to cure sickle cell disease and beta thalassemia could enter the clinic later this year.
Under the plan, the therapies will be available for free for patients, with an approximate cost of $35,000 per dose covered by the Brazilian public health system. Dropulic and Orentas believe an approved product could be available within three years.
Caring Cross aims to slash production costs with its point-of-care manufacturing model. Development and manufacturing can be executed entirely in modular units which are 56 by 13 feet and can be set up anywhere.
“When you make these products at the point of care or close to a hospital, you significantly decrease these logistical costs,” Dropulic said.
Orentas added that it’s already dawned on the managed care systems in countries such as Spain, Germany and Denmark that the way gene therapies are produced in the U.S. is “not sustainable.” Even with the high cost of doing business in the U.S., Caring Cross believes it could deliver CAR-T therapies for around $80,000, Orentas said.
In the U.S., cell and gene therapy prices currently range from hundreds of thousands of dollars to millions of dollars.
Caring Cross's Brazilian partner has "biomanufacturing expertise" and "an experienced workforce," Orentas said. Fiocruz is the world’s largest producer of the yellow fever vaccine. It also served as Brazil’s home base for production of its AstraZeneca-partnered COVID vaccine.
Meanwhile, through its for-profit CDMO spinout, Vector BioMed, Caring Cross is developing technologies to improve the accessibility of CAR-T and other therapies.