Chimeric antigen receptor (CAR) T-cell therapies involve harvesting a patient’s own T-cells, genetically modifying and multiplying them ex vivo, then infusing them back into the patient.
The harvest and infusion takes place at a hospital or a clinic, while the manufacturing steps take place at a specialised facility: Novartis’ approved therapy Kymriah (tisagenlecleucel) is made at its facility in Morris Plains, New Jersey, for example, while Gilead/Kite’s Yescarta (axicabtagene ciloleucel) is made at a plant in El Segundo, California.
But during a third quarter financial conference call Wednesday, fellow CAR T-cell manufacturer Juno Therapeutics was asked about the potential of the hospitals and clinics eventually competing in this field and making such therapies themselves.
CEO Hans Bishop said the difficulty of making such a highly regulated and complex product made this eventuality unlikely.
“First of all, it requires, particularly to do this at scale in a highly controlled way, dedicated equipment, highly trained people. The other point is, which I think is often lost, is how important the investment is in quality control and quality assurance. And those activities can represent close to 50% of the cost to making a Car T cell.”
Juno has a manufacturing facility in Bothell, Washington.
Bishop added his (and other developer’s) firm’s investments in capabilities and people have created a centralised approach to T-cell manufacturing, bringing the benefit of high throughput through the dedicated plant (or plants).
“The utilisation of doing that at multiple institutions where you're going to have much more variable demand is quite challenging from a cost and capability perspective,” he told investors. “So we continue to have strong conviction that the best way to make these therapies of patients is in centralised facilities.”
He also said new technologies will “dramatically” change future T-cell manufacturing, and investments such as Juno’s acquisition of automation-focused tech firm Stage Cell Therapeutics in 2015 give the firm an advantage going forward.
“[Such acquisitions] are going to yield, I think, the real improvements in turnaround time and cost of goods. And again, it would seem very challenging to think that a hospital could make those very significant investments in new technologies as they become critical looking forward.”
For the three months ending September 30, Juno reported revenues of $45m, 114% higher year-on-year, though net loss stood at $118m, more than double the same period last year.