Tecelra: which tox species, and why?

“Standard in vivo single-dose or repeat-dose toxicity studies were not conducted with afamitresgene autoleucel due to the lack of appropriate animal models for testing of human TCR engineered T-cells.”

“Because afamitresgene autoleucel is an autologous engineered-TCR T-cell therapy, there is a mismatch of MHC antigens between animal and human TCRs, so specificity cannot be assessed.”

“Engineering an animal TCR for use in animal model testing would also not reflect the specificity/safety profile of the human TCR, and therefore would be uninformative.”