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big commercial problem that’s more familiar to the consumer technology world: Constant new iterations of products. Put another way, CAR-T cells could be the iPhones of the biotech world.
CAR-T products are going to have “rapid” life cycles because there are going to be consistent improvements to them, Carl June said Thursday. “Hopefully the field can move forward at about the pace that cell phones change.”
Some of those improvements are already in progress. As Xconomy reported in July, researchers at Memorial Sloan-Kettering Cancer Center in New York have been working to get into clinical testing with a CAR-T product that has two “extra” modifications: A chemical signal that recruits the patient’s unmodified T cells to help with the attack; and a self-destruct mechanism that clinicians can trigger in case the cells go haywire.
The trial, for relapsed ovarian cancer, could be the first test of a so-called armored CAR.
CAR-T therapies could also see improvements in combination with other drugs or with more efficient manufacturing processes. But one problem with making manufacturing changes is that regulators can demand a new set of clinical trials, arguing in essence that the new process has created a new product. June said he hopes for “flexibility” from regulators, but no one really knows how they’ll react.
“I don’t think we can just willy-nilly make changes and expect regulators, patients, and physicians to accept them because the biology makes sense,” Harr says. “We’re going to have to define the associated clinical benefit.”
These are just a few of the myriad questions CAR-T products will have to answer as these therapies make their way to the FDA. Novartis is aiming for an FDA approval next year. Juno has said that it aims to file papers either late next year or early 2017 seeking approval of its first product, and Kite is targeting a potential launch that year as well. All of these products are designed to treat blood cancers like acute lymphoblastic leukemia, diffuse large B-cell lymphoma, and follicular lymphoma. You can expect the next wave to come quickly afterwards.
“We do view this a bit like software, where you will have relatively rapid cycles of innovation,” Harr says.
Photo of healthy T cell courtesy of NIAID via Creative Commons license.