Until the US Food and Drug Administration (FDA) approved the first gene modified cell therapy product in the form of Novartis’ Kymriah (tisagenlecleucel), Gilead Science’s agreement to buy Kite Pharma was the biggest CAR-T cell-related story of the week.
The $11.9bn (€10bn) deal will see Gilead launch into the cell therapy space, adding the chimeric antigen receptor (CAR) T cell therapy candidate axicabtagene ciloleucel (axi-cel), currently under regulatory review in the US and Europe.
According to CEO John Mulligan, Kite showing “manufacturing on an industrial scale could work” helped convince Gilead “that now is the right time to get involved in this kind of therapy.”
He told investors in a conference call: “Kite was the right partner for us to work together because they've everything they need for the first generation. They're already thinking about and working on next generation. They have solved the manufacturing problem.”
Manufacturing expansion
Axi-cel is made by isolating peripheral blood mononuclear cells, including T-cells, from the patient’s own white blood cells, which are then sent to Kite’s facility for transduction with a retroviral vector. The site in El Segunda, California opened in June 2016 and has the capacity to produce volumes of the autologous therapy for up to 4,000-5,000 patients per year.
But while axi-cel has been submitted for regulatory review with the EMA, manufacturing plans have yet to be decided regarding the supply in Europe.
“The manufacturing is entirely in the United States and so that will limit what we can do,” Mulligan said, adding his firm and Kite were set to “work together to accelerate the expansion of manufacturing operations.”
Reproducible and scalable
Kite is Gilead’s first foray into biological manufacturing and of the benefits of this therapy is that it will not have to commit to large-scale stainless steel “$1 billion plants you often have to build if you want to get into the biologics,” Mulligan continued.
“It's a much more cost effective scale of and that it's reproducible and often you can build in the United States and you can reproduce that in the Europe, again in a fairly cost effective way from a capital expenditure point of view,” he added.
“We became enamoured with the Kite philosophy of how to do that, how to do build the station, how do get the workflow through, how to run multiple shifts so that you could achieve the kind of patient flows that you wanted, the kind of flows necessary to support the patient flows that we expect in the future.
“They are committed to simplifying the system, so the future manufacturing is more cost effective and more scalable.”