Considerations on the nonclinical studies of bispecific antibody constructs
YAN Li-ping
ZHANG Min
WANG Qing-li
WANG Hai-xue
Abstract：In recent years,bispecific antibodies (bispecifics,bsAbs) have been the spotlights of new therapeutics development,with the dramatic expansion of the biotechnology.The most amazing action is the T cell redirection induced tumor lysis by the simultaneous targeting on T cell and tumor cell.bsAbs comprise a heterogeneous compound class and have profound action mechanisms.Therefore the development to bsAbs is more challenging than general antibodies.Nonclinical studies should be designed and executed basing on the guidance for biopharmaceuticals.In addition,special attention should be paid to the selection of relevant animal species,immunotoxicity such as cytokine release syndrome,and the determination of first-in-human dose.This paper presents special considerations on the nonclinical studies of bsAbs to provide references for the developers and reviewers.
Keywords：bispecific antibodies (bsAbs)nonclinical studiesoncology therapyrelevant animal speciescytokine release syndromedetermination of first-in-human dose
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2008-2013 )