Brazil aims to manufacture its own cell therapies — at a fraction of the current cost

Brazil’s Ministry of Health is working with a US nonprofit to locally manufacture CAR-T therapies and potentially other cell and gene therapies at a much lower cost.

The goal is to provide cell therapy free of charge to patients while charging Brazil’s health system around $35,000 a dose, which is roughly one-tenth of the cost in Europe and an even smaller fraction of US costs.

CAR-T therapies have transformed the treatment of certain blood cancers, but a course of treatment can cost nearly $500,000 in the US, and widespread access has been plagued by limited supply and complex manufacturing processes.

The treatments have remained out of reach in many regions outside the US and Europe. The first US approval came in 2017 for Novartis’ lymphoma CAR-T therapy Kymriah.

Fiocruz, the public health and research foundation operated by Brazil’s Ministry of Health, and the nonprofit Caring Cross announced the initiative on Tuesday. Caring Cross executive director ​​Boro Dropulić told Endpoints News in February that the two organizations began discussing the program a year and a half ago.

“We got into a discussion on, ‘How can we tech transfer and teach Fiocruz and Bio-Manguinhos on how to manufacture all the components needed to produce these CAR therapies for their patients?’” he said.

Bio-Manguinhos, also known as the Institute of Technology on Immunobiologicals, is the Fiocruz arm in charge of manufacturing vaccines, diagnostics and biologics. It will be tasked with manufacturing the cell therapies.

Dropulić founded Lentigen, the company behind the lentiviral vector used in Kymriah. He is also the head of Vector BioMed, a viral vector contract manufacturer that was spun out of Caring Cross and manufactures therapies for the nonprofit “at cost plus a small markup.”

Caring Cross is providing the technology and training to manufacture CAR-T therapies to Fiocruz. Fiocruz is compensating Caring Cross for the tech transfer, while materials are provided at “far below current commercial pricing,” Dropulić said. Exact terms of the agreement were not disclosed.

The initial program will focus on CAR-T therapies for leukemia and lymphoma. The partners plan to run clinical trials for experimental therapies and then seek approval in Brazil, he noted. The first studies are expected to begin this year or in early 2025, Dropulić said.

The partners hope to one day develop cell therapies for HIV and potentially sickle cell, Dropulić said. They plan to use a CAR-T therapy developed for HIV by Caring Cross and researchers at the University of California, Davis, and UCSF. It’s already in a clinical trial in the US that’s sponsored by the California Institute for Regenerative Medicine.

The initiative is one of several around the world aimed at improving access to CAR-T treatment. Biotech companies in India, such as ImmunoACT and Immuneel, are working on developing affordable CAR-T therapies, and in October ImmunoACT won the first approval of a CAR-T therapy in India. In Europe, a special policy has enabled some hospitals to make their own CAR-T therapies, STAT News reported.

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