Sadekar S, Figueroa I, Tabrizi M
DMPK and Disposition, Biologics Discovery, Merck Research Laboratories, Palo Alto, CA, 94304, USA.
AAPS J. 2015 Jul;17(4):828-36. doi: 10.1208/s12248-015-9766-0. Epub 2015 May 2.
Antibody drug conjugates (ADCs) are a multi-component modality comprising of an antibody targeting a cell-specific antigen, a potent drug/payload, and a linker that can be processed within cellular compartments to release payload upon internalization. Numerous ADCs are being evaluated in both research and clinical settings within the academic and pharmaceutical industry due to their ability to selectively deliver potent payloads. Hence, there is a clear need to incorporate quantitative approaches during early stages of drug development for effective modality design and target selection. In this review, we describe a quantitative approach and framework for evaluation of the interplay between drug- and systems-dependent properties (i.e., target expression, density, localization, turnover, and affinity) in order to deliver a sufficient amount of a potent payload into the relevant target cells. As discussed, theoretical approaches with particular considerations given to various key properties for the target and modality suggest that delivery of the payload into particular effect cells to be more sensitive to antigen concentrations for targets with slow turnover rates as compared to those with faster internalization rates. Further assessments also suggest that increasing doses beyond the threshold of the target capacity (a function of target internalization and expression) may not impact the maximum amount of payload delivered to the intended effect cells. This article will explore the important application of quantitative sciences in selection of the target and design of ADC modalities.
抗体药物偶联物(ADCs)是一种多组分药物,由靶向细胞特异性抗原的抗体、强效药物/有效载荷以及一种连接子组成,该连接子可在细胞区室内被加工处理,以便在被内化后释放有效载荷。由于其能够选择性地递送强效有效载荷,众多抗体药物偶联物正在学术和制药行业的研究及临床环境中接受评估。因此,在药物开发的早期阶段,显然需要采用定量方法来进行有效的药物设计和靶点选择。在本综述中,我们描述了一种定量方法和框架,用于评估药物依赖性特性与系统依赖性特性(即靶点表达、密度、定位、周转率和亲和力)之间的相互作用,以便将足量的强效有效载荷递送至相关靶细胞中。如前所述,对靶点和药物的各种关键特性予以特别考虑的理论方法表明,与内化速率较快的靶点相比,对于周转率较慢的靶点,将有效载荷递送至特定效应细胞对抗原浓度更为敏感。进一步的评估还表明,超过靶点容量阈值(靶点内化和表达的函数)增加剂量可能不会影响递送至预期效应细胞的有效载荷的最大量。本文将探讨定量科学在靶点选择和抗体药物偶联物药物设计中的重要应用。