Is the FDA adapting to cell therapies ? How ? Why and how cell therapy differ from small molecules ? A quick overview with Neil Sheppard, D.Phil, Adjunct Associate Professor in the Department of Pathology & Laboratory Medicine, and Head of the T Cell Engineering Lab (TCEL), at the Center for Cellular Immunotherapies (CCI) at the University of Pennsylvania
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Cell therapy it’s much more modular. Because you know, when we design a CAR, the CAR has several different components. And if we change any component, we have to open a new IND and that takes a long time. So now the FDA has a system set up that will potentially let you do kind of an umbrella protocol. Where you still need to submit all of the required data for each of your variations on the theme. So you might have a CAR recognizing a certain antigen.
And then you might have the same CAR with some kind of armament or you know armament A, armament B. And you might be able to study them all in one clinical protocol under kind of a nested IND.
So that would certainly optimize our approach here. Because otherwise it’s very laborious to obtain an entirely new IND for a very similar therapy. And that problem really hasn’t existed before of course the regulatory structure we have is largely developed in response to small molecule and then more lately monoclonal antibody therapy. And in those cases, it wasn’t generally like if you change even a single atom on a small molecule you can end up with a very different small molecule so it wasn’t modular in the way that’s for cell therapy. And even if you don’t change the CAR, changing the manufacturing protocol -and there’s some innovation there – so you know that traditional CAR-T autologous manufacturing protocol is 9 to 11 days. Novartis is now publishing,
showing some data conferences from its T-Charge platform which is only two days.
And U. Penn recently published a one-day protocol. So those would have a quite a large impact on… The process is the product, pretty much for living cells. So even if you don’t change anything genetically about your therapy, changing the process can have a big impact. And being able to do that efficiently without having to undergo the full IND process for every incremental change, I think could be important.