Bispecific antibodies in cancer therapy: Target selection and regulatory requirements.

Yanze Sun; Xinmiao YU; Xiao Wang; Kai Yuan; Gefei Wang; Lingrong HU; Guoyu Zhang; Wenli Pei; Liping Wang; Chengliang Sun; Peng Yang

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Bispecific antibodies in cancer therapy: Target selection and regulatory requirements.

Author: Yanze SUN ¹ ; Xinmiao YU ¹ ; Xiao WANG ¹ ; Kai YUAN ¹ ; Gefei WANG ¹ ; Lingrong HU ¹ ; Guoyu ZHANG ¹ ; Wenli PEI ¹ ; Liping WANG ¹ ; Chengliang SUN ¹ ; Peng YANG ¹
Author Information

1. State Key Laboratory of Natural Medicines and Jiangsu Key Laboratory of Drug Design and Optimization, China Pharmaceutical University, Nanjing 210009, China.
Publication Type:Review
Keywords: Bispecific antibody; Cancer immunotherapy; Clinical trials; Mechanism; Oncology; Regulatory guidance; Structure; Target selection
From: Acta Pharmaceutica Sinica B 2023;13(9):3583-3597
CountryChina
Language:English
Abstract: In recent years, the development of bispecific antibodies (bsAbs) has been rapid, with many new structures and target combinations being created. The boom in bsAbs has led to the successive issuance of industry guidance for their development in the US and China. However, there is a high degree of similarity in target selection, which could affect the development of diversity in bsAbs. This review presents a classification of various bsAbs for cancer therapy based on structure and target selection and examines the advantages of bsAbs over monoclonal antibodies (mAbs). Through database research, we have identified the preferences of available bsAbs combinations, suggesting rational target selection options and warning of potential wastage of medical resources. We have also compared the US and Chinese guidelines for bsAbs in order to provide a reference for their development.