肿瘤治疗性mRNA疫苗非临床评价的考虑
Consideration on the non-clinical evaluation of therapeutic mRNA vaccines for tumors
吴爽 1王寅 1尹华静 1李峥 1尹茂山 1于冰1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 折叠
摘要
肿瘤治疗性mRNA疫苗作为一种新型肿瘤治疗方式受到广泛关注,目前多数产品正处于临床前或临床研究阶段,国内外尚无成熟的产品上市.由于肿瘤治疗性mRNA疫苗的靶点特性、作用机制、递送特征,以及人体与动物免疫系统存在的差异,使得此类产品在非临床试验设计和评价中情况更复杂.其中动物模型的选择不仅是非临床有效性关注的内容,也是毒性评价的关键考虑因素.本文从肿瘤治疗性mRNA疫苗产品非临床试验设计的角度,根据此类产品自身特点,通过分析、总结已开展临床产品的非临床研究,结合相关指导原则,探讨此类产品非临床评价关注的问题.
Abstract
Therapeutic mRNA vaccine for tumors attracted much attention as a new type of tumor treatment,and most products are in the preclinical and clinical research stage,and there has not post-market drug.However,the non-clinical evaluation of therapeutic mRNA vaccines for tumors is more complicated,due to their target features,mechanisms,delivery patterns,and the cross-species differences of immune system.The choice of animal model is not only content of the clinical effectiveness,and it was a key factor of toxicity assessment.In this work,the challenges for non-clinical evaluation of therapeutic mRNA vaccines for tumors are discussed,and the compliant requirements are reviewed,and the general considerations are suggested.
关键词
肿瘤治疗性mRNA疫苗/非临床研究/动物模型Key words
therapeutic mRNA vaccine for tumors/non-clinical evaluation/animal model引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据