Biotech Values

[dewophile]

JUNO

From Herper's piece:

Twenty patients have been enrolled in the study, with as many as 90 planned. Out of those, Harr says, only a minority have been treated with fludarabine.

so 3 deaths in the fludarabine patients, who constituted a minority of the 20 total - so 3 out of <10 died. That is seriously scary
The fact they pin this on fludarabine, but will continue w fludarabine in their other cd19 drugs has to be concerning. Granted different constructs, and the other drugs have a built in kill switch, but still..hopefully it is just unique to this particular drug/conditioning agent
I haven't listented to the cc, but I would assume these pts had cytokine storm, high tumor burden, probably older, or other factors that can help mitigate tox moving forward (in addition to just ridding of fludarabine). If this was at all preventable w one of the agents w an ablation gene built in why wouldn't the FDA just kill the drug altogether and make the company move forward w one of the newer constructs?