摘要
治疗性肿瘤疫苗是肿瘤免疫治疗产品开发的热点,至今通过临床评价正式上市的产品仍寥寥无几。患者肿瘤异质性和人白细胞抗原(human leukocyte antigen,HLA)异质性是阻碍治疗性肿瘤疫苗发展的主要因素。针对该问题,开发个体化治疗性肿瘤疫苗是此类疫苗发展的前沿领域和未来方向,如何科学评价其临床前药效作用也是开发此类产品面临的挑战。本文通过分析总结肿瘤抗原和肿瘤疫苗的分类及特点、个体化治疗性肿瘤疫苗的作用机制及影响因素、个体化治疗性肿瘤疫苗的临床前药效学研究进展,以期为进行相关药效学研究提供参考。
Therapeutic tumor vaccine has become a hot spot in the development of tumor immunotherapy products;however,few products have been officially entered market through clinical evaluation. Both tumor heterogeneity and human leukocyte antigen( HLA) heterogeneity in patients are the main factors that hinder the development of therapeutic tumor vaccines. Focusing on this problem,personalization is the frontier field and future direction in developing therapeutic tumor vaccine. How to scientifically evaluate the preclinical efficacy of personalized therapeutic tumor vaccine is also a challenge to develop such products. This paper analyzes and summarizes the classification and characteristics of tumor antigen and tumor vaccine,mechanism and influencing factors of personalized therapeutic tumor vaccine and the progress of preclinical pharmacodynamics study on personalized therapeutic tumor vaccine,in order to provide a reference for related pharmacodynamics researches.
作者
贺庆
高华
王军志
HE Qing;GAO Hua;WANG Jun-zhi(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第21期2401-2409,共9页
Chinese Journal of New Drugs
基金
国家“重大新药创制”科技重大专项资助项目(2018ZX09101-001):创新生物技术药评价及标准化关键技术研究。
关键词
个体化
治疗性肿瘤疫苗
药效学
肿瘤抗原
personalized
therapeutic tumor vaccine
pharmacodynamics
tumor antigen