Cynomolgus monkey only (rabbit used for SC local tolerance only)
“The cynomolgus monkey was selected as the only pharmacologically relevant species for the nonclinical PK and toxicology assessments of teclistamab based on cross-species comparisons of sequence homology, relative target-binding affinities, and functional activity in cell-based assays.”
✓ VerifiedFDA multi-discipline review, p. 41Source ↗
Why that species
Binds monkey CD3 and BCMA (BCMA ~36-fold lower affinity); no rodent CD3 binding, rabbit not expected to bind
“The parental CD3 monoclonal antibody did not bind rodent CD3, and teclistamab is not expected to bind rabbit CD3 or BCMA due to low sequence similarity; thus, the cynomolgus monkey was determined to be a pharmacologically relevant species for toxicology studies.”
✓ VerifiedFDA multi-discipline review, p. 37Source ↗
Surrogate molecule
No surrogate; clinical molecule tested in monkey
“The toxicity and toxicokinetics (TK) of teclistamab were evaluated in a 5-week repeat-dose toxicity study in cynomolgus monkeys.”
✓ VerifiedFDA multi-discipline review, p. 37Source ↗