Breitbach Caroline J
Turnstone Biologics, Ottawa, ON, Canada.
Methods Mol Biol. 2020;2058:285-293. doi: 10.1007/978-1-4939-9794-7_19.
Oncolytic viral immunotherapy based on the MG1 Maraba platform has undergone extensive preclinical evaluation, resulting in the advancement of two programs into clinical trials. MG1 Maraba encoding tumor antigens (tumor associated antigens or viral antigens) are used to boost antitumor immunity, while MG1 Maraba infects tumors, causes oncolysis and transforms the tumor microenvironment. An overview of MG1 Maraba clinical development is outlined here, along with general considerations relating to the design of clinical trials for complex biologic products such as oncolytic viral immunotherapies. These include choice of patient population, optimized treatment regimen, and endpoints which provide early signals of activity and inform the late-stage development path of these agents with novel mechanisms of action.
基于MG1马拉巴病毒平台的溶瘤病毒免疫疗法已进行了广泛的临床前评估，使得两个项目得以推进至临床试验阶段。编码肿瘤抗原（肿瘤相关抗原或病毒抗原）的MG1马拉巴病毒用于增强抗肿瘤免疫力，而MG1马拉巴病毒感染肿瘤、引起肿瘤溶解并改变肿瘤微环境。本文概述了MG1马拉巴病毒的临床开发情况，以及与溶瘤病毒免疫疗法等复杂生物制品临床试验设计相关的一般考虑因素。这些因素包括患者群体的选择、优化的治疗方案以及能够提供早期活性信号并为这些具有新型作用机制的药物后期开发路径提供信息的终点指标。
