NorthWest Biotherapeutics Inc (NWBO)

[Smokey21]

Competitive technologies having their own challenges:

"If ASH was another scientific meeting where interest in CAR-T therapies mounted, an obvious theme was just how much more work still needs to be done to get beyond the relatively accessible low-hanging fruit of acute lymphoblastic leukaemia (ALL).

And that goes for all the big players – Novartis, Juno and Kite Pharma – whose leading CD19-directed projects featured in several presentations over the conference. While remission rates of 90% are common in ALL, in lymphomas they are closer to 50%; moreover, some fundamental problems continue to plague CAR-T therapies.

One is safety: cytokine release syndrome and neurotoxicity remain problematic, though the NCI said it was now using an adverse event treatment grading flowchart to minimise toxicity while maximising response. Another is durability: even in ALL studies hitting 90% initial remission, most of these relapse within a year.

Then there is manufacturing. A particularly worrying revelation by the University of Pennsylvania’s Dr Stephen Schuster came from a study of the most advanced CAR-T player, Novartis’s CTL019, in a study in patients with relapsed/refractory B-cell lymphomas.

Of 43 patients enrolled, 13 could not be infused – six owing to production failure. Followers of a project that apparently is to be filed for regulatory approval next year could find this alarming"

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