“The nonclinical toxicity profile of epcoritamab was established in a series of nonclinical safety studies in cynomolgus monkeys, the only cross-reactive toxicology species.”
✓ VerifiedFDA multi-discipline review, p. 53Source ↗
Why that species
Similar affinity for human and monkey CD3/CD20; no binding to dog, pig, rat, mouse CD20; CD3 not expected in other species
“The epcoritamab binding data indicates that among the species tested, the cynomolgus monkey is the only pharmacologically relevant species for toxicology studies.”
✓ VerifiedFDA multi-discipline review, p. 43Source ↗
Surrogate molecule
No surrogate; clinical molecule tested in monkey
“We agree that the cynomolgus monkey is a pharmacologically relevant nonclinical species to assess the toxicity of epcoritamab, and general toxicology studies in other species are not warranted.”
✓ VerifiedFDA multi-discipline review, p. 56Source ↗