Elrexfio: which tox species, and why?

“Cynomolgus monkey was identified as the only relevant nonclinical toxicology species based on elranatamab binding affinities for BCMA and CD3.”

“Selection of cynomolgus as relevant species appears adequate, based on comparable binding affinity of elranatamab to cynomolgus and human BCMA and CD3, and a comparable frequency and phenotype of cynomolgus and human BCMA+ cells.”

“General toxicology studies were conducted in cynomolgus monkeys, a pharmacologically relevant species to assess the toxicity of elranatamab.”

“General toxicology studies were conducted in cynomolgus monkeys, a pharmacologically relevant species to assess the toxicity of elranatamab.”

“Stand-alone reproductive and development toxicity studies have not been conducted with elranatamab. Effects on reproductive organs were assessed as part of the repeat-dose toxicity studies.”

“Carcinogenicity studies with elranatamab have not been conducted since they are generally not required for advanced cancer and protein-based biotherapeutics per ICH S9 and ICH S6(R1), respectively.”

“Selection of cynomolgus as relevant species appears adequate, based on comparable binding affinity of elranatamab to cynomolgus and human BCMA and CD3, and a comparable frequency and phenotype of cynomolgus and human BCMA+ cells.”