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用于非肿瘤应用的抗体药物偶联物的开发与临床前评估概述

An Overview of the Development and Preclinical Evaluation of Antibody-Drug Conjugates for Non-Oncological Applications.

作者信息

Pal Lal Bahadur, Bule Prajakta, Khan Wahid, Chella Naveen

机构信息

Department of Pharmaceutical Technology (Formulations), National Institute of Pharmaceutical Education and Research (NIPER), Guwahati 781101, Assam, India.

Natco Research Centre, Natco Pharma Ltd., Hyderabad 500018, Telangana, India.

出版信息

Pharmaceutics. 2023 Jun 24;15(7):1807. doi: 10.3390/pharmaceutics15071807.

DOI:10.3390/pharmaceutics15071807
PMID:37513995
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10385119/
Abstract

Typically, antibody-drug conjugates (ADCs) are made up of a humanized antibody and a small-molecule medication connected by a chemical linker. ADCs' ability to deliver cytotoxic agents to the specific site with reduced side effects showed promising results in oncology. To date, fourteen ADCs have been approved by the US Food and Drug Administration, and approximately 297 ADCs are in pre-clinical/clinical stages in the oncology area. Inspired by these outcomes, a few scientists explored the potential of antibody-drug conjugates in non-oncological conditions such as arthritis, myasthenia gravis, immunological disorders, and kidney failure. However, there are limited data available on the non-oncological applications of antibody-drug conjugates. This current review focuses on the non-oncological applications of antibody-drug conjugates, their developmental studies, testing procedures, in vitro evaluations, and pre-clinical testing. Additionally, a summary of the restrictions, difficulties, and prospects for ADCs in non-oncological applications is provided.

摘要

通常,抗体药物偶联物(ADCs)由人源化抗体和通过化学连接子连接的小分子药物组成。ADCs能够将细胞毒性药物递送至特定部位并减少副作用,这在肿瘤学领域显示出了有前景的结果。迄今为止,已有14种ADCs被美国食品药品监督管理局批准,并且在肿瘤学领域约有297种ADCs正处于临床前/临床阶段。受这些成果的启发,一些科学家探索了抗体药物偶联物在非肿瘤疾病如关节炎、重症肌无力、免疫紊乱和肾衰竭中的潜力。然而,关于抗体药物偶联物非肿瘤应用的数据有限。本综述聚焦于抗体药物偶联物的非肿瘤应用、其研发研究、测试程序、体外评估和临床前测试。此外,还提供了ADCs在非肿瘤应用中的限制、困难和前景的总结。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c56/10385119/a045ff46edad/pharmaceutics-15-01807-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c56/10385119/d278c14cb432/pharmaceutics-15-01807-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c56/10385119/a045ff46edad/pharmaceutics-15-01807-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c56/10385119/d278c14cb432/pharmaceutics-15-01807-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c56/10385119/a045ff46edad/pharmaceutics-15-01807-g002.jpg

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