Executive Summary
Anselamimab (CAEL-101) is an investigational, first-in-class fibril-reactive chimeric monoclonal antibody developed by AstraZeneca (following the 2021 Alexion acquisition + Alexion’s 2021-09 Caelum Biosciences buyout for up to $500M) targeting the misfolded light chain amyloid fibrils deposited in tissues across patients with systemic light chain (AL) amyloidosis. Specifically, anselamimab binds an epitope shared by both kappa and lambda misfolded light chain fibrils, opsonising amyloid deposits to engage Fc-mediated macrophage clearance and accelerate organ amyloid fibril removal beyond plasma cell-directed clone suppression with daratumumab + CyBorD backbone. As a result, AstraZeneca advances anselamimab through two Phase 3 registrational programs: CARES-1 (Mayo Stage IIIb advanced cardiac AL amyloidosis) + CARES-2 (Mayo Stage IIIa).