Biotech Values

[poorgradstudent]

BLCM:

Also, I have read some make the point that even if no GvHD is shown with longer treatment, how will we know that is due to the BLCM drug? Guess we would either need to see a large randomized, controlled trial, or at least support that the BLCM switch itself resolved the GvHD?

I understand the question but it is a bit of a double-edged sword, perception wise, for BLCM. Part of the point of the safety switch is also to be able to expand the number of donors, thereby increasing the number of recipients undergoing transplants. The BP-004 trial has an inclusion criteria that requires the recipient to lack an HLA identical donor, so you're already raising the bar for safety and working to expand accessibility of transplants. So more transplants without noticeable GVHD would be ideal and a sign of success, but it would also "look" like the safety switch is superfluous.

Agree that for this trial specifically, longer follow-up will be nice. But transplants have rather high mortality in general, so (sadly) you won't need to wait too long to get an idea regarding the efficacy of this general strategy.