Consideration on the non-clinical evaluation of therapeutic mRNA vaccines for tumors

VernacularTitle:肿瘤治疗性mRNA疫苗非临床评价的考虑
Author: Shuang WU ¹ ; Yin WANG ; Hua-Jing YIN ; Zheng LI ; Mao-Shan YIN ; Bing YU
Author Information

1. 国家药品监督管理局药品审评中心,北京 100076
Keywords: therapeutic mRNA vaccine for tumors; non-clinical evaluation; animal model
From: The Chinese Journal of Clinical Pharmacology 2024;40(20):3061-3064
CountryChina
Language:Chinese
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.