In vivo CAR-T manufactured and priced like a generic biologic
Instead of making cell therapy from each patient's own cells in a factory, inject a particle that reprograms immune cells inside the body, made in bulk, so a dose costs thousands rather than hundreds of thousands.
Autologous CAR-T costs hundreds of thousands of dollars and weeks of manufacturing per patient, restricting it to a small fraction of eligible patients in rich countries. In vivo CAR generation with lipid nanoparticles or targeted lentiviral vectors (Umoja, Interius, Orna and others) has entered the clinic in B-cell malignancies. The proposal is a coordinated programme to develop an in vivo CD19 or BCMA product with a manufacturing process and cost-of-goods target under $5,000 per dose, licensed for distribution through generic-style manufacturers in middle-income countries, with regulatory pathways agreed in advance.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
- Most of the world has almost no cancer care · Seven in ten cancer deaths happen in low- and middle-income countries, where radiotherapy, pathology, surgery and drugs are scarce.
- Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.