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项与 PGV002 mRNA vaccine(NeoCura Bio-Medical Technology) 相关的临床试验A Dose-Escalation and Dose-Expansion Study Evaluating the Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Solid Tumors
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA personalized neoantigen tumor vaccine in the treatment of advanced solid tumors, including two phases: dose escalation and dose expansion. The main objective is to evaluate the safety and tolerability of personalized neoantigen tumor vaccine in subjects with advanced solid tumors, and secondary objective is to preliminarily evaluate the efficacy of personalized neoantigen tumor vaccine in subjects with advanced solid tumors. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment will be performed in combination with PD-1 to further evaluate the efficacy and safety profile of personalized neoantigen tumor vaccine at a specific dose.
Both the dose escalation phase and dose expansion phase include a screening period (Week -4
Week -2), a baseline period (Week -1
Day -1), a treatment period (Day 1
Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1
Week 8) and the enhanced treatment period (Week 12
Week 16). The investigator determine if the subject is suitable to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors.
Dose escalation phase is the traditional 3 + 3 design,, 12-18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (3-6 subjects in each group). The low dose group will be enrolled first.
The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1 will be administered in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine. About 18 subjects will be enrolled. The usage and dosage of PD-1 should aligned with the package insert.
A Dose-Escalation and Dose-Expansion Study Evaluating the Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Gastric Cancer, Esophageal Cancer and Liver Cancer
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, esophageal cancer, and liver cancer, including two phases: dose escalation and dose expansion. To evaluate the safety and tolerability of neoantigen tumor vaccine in subjects with advanced gastric cancer, esophageal cancer and liver cancer by conducting dose escalation trial in subjects diagnosed with advanced gastric cancer, esophageal cancer and liver cancer, and preliminarily evaluate the efficacy of neoantigen tumor vaccine in subjects with advanced gastric cancer, esophageal cancer and liver cancer. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment is performed in combination with PD-1/L1 to further evaluate the efficacy and safety profile of neoantigen tumor vaccine at a specific dose.
Both the dose escalation phase and dose expansion phase include a screening period (Week -4
Week -2), a baseline period (Week -1
Day -1), a treatment period (Day 1
Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1
Week 8) and the enhanced treatment period (Week 12
Week 16). The investigator determined whether to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors from Week 8 to Week 12.
The dose escalation phase follows standard 3+3 design. 12-18 subjects are expected to be enrolled at 3 given dose level.
The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1/L1 drugs are used in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine, with about 18 subjects. The usage and dosage of PD-1/L1 should aligned with the package insert.
100 项与 PGV002 mRNA vaccine(NeoCura Bio-Medical Technology) 相关的临床结果
100 项与 PGV002 mRNA vaccine(NeoCura Bio-Medical Technology) 相关的转化医学
100 项与 PGV002 mRNA vaccine(NeoCura Bio-Medical Technology) 相关的专利(医药)
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项与 PGV002 mRNA vaccine(NeoCura Bio-Medical Technology) 相关的新闻(医药)随着全球新冠的消退,人们对mRNA疫苗的关注从新冠病毒转移到了肿瘤治疗领域。事实上,肿瘤治疗领域是mRNA技术最早的应用领域之一,但是由于其开发难度较高,进度较慢,大多数产品还处于早期临床及临床前阶段。但是随着全球制药巨头们对肿瘤免疫治疗的积极布局,带动了mRNA肿瘤免疫治疗的整体发展。mRNA技术在肿瘤治疗上主要分为两类技术路线——mRNA肿瘤疫苗和mRNA肿瘤治疗。mRNA肿瘤疫苗mRNA肿瘤疫苗,通常设计mRNA编码肿瘤新抗原(个性化疫苗)或者肿瘤特异性抗原(通用型疫苗),使得机体对这些抗原产生免疫反应,以对抗肿瘤。mRNA肿瘤疫苗大多数设计用于与PD-1等免疫检查点进行联合使用。延伸阅读:五类mRNA肿瘤疫苗在该技术路线上,国外以mRNA企业Moderna、BioNTech为主要竞争者,同时辉瑞、默沙东、赛诺菲等巨头公司都以合作或投资的方式参与这一新型肿瘤疫苗技术的开发。在国内,则以斯微生物、艾博生物、新合生物、美诺恒康、深信生物、丽凡达生物、瑞吉生物等Biotech为主要玩家,还未见传统药企的下场和布局。进入临床阶段的mRNA肿瘤疫苗项目(*如有缺漏欢迎留言补充)目前,全球范围内已经有十多款mRNA肿瘤疫苗项目推进临床开发阶段。此外,还有多款正在进行IIT的mRNA肿瘤疫苗产品,例如新合生物的PGV-002。但是领先的几款产品集中在黑色素瘤,直接形成竞争关系的是Moderna的mRNA-4157和BioNTech的BNT122。但是相较于肿瘤疫苗的其他类型,例如DC疫苗、多肽疫苗,mRNA肿瘤疫苗研发难度更高,包括载体、靶点、制剂等挑战。mRNA肿瘤免疫治疗mRNA肿瘤免疫治疗,可以设计mRNA编码细胞因子(例如IL-12、IFNα、GM-CSF)、或治疗性抗体、或激动剂等,以激活免疫系统对抗肿瘤。进入临床阶段的mRNA肿瘤治疗项目(*如有缺漏欢迎留言补充)在该领域上,也是以Moderna、BioNTech和CureVax为主要代表。但是该技术路线的研发难度更高,其安全性问题和疗效是最大的挑战。也正因此,在2022年,该领域遇到了一些挫折。2022年8月,Moderna宣布决定停止一款靶向IL-2的mRNA药物(mRNA-6231)开发,原因是基于该款药物“早期临床数据以及其竞争力”两方面考虑。此外,阿斯利康也宣布放弃与Moderna公司合作开发的心血管疾病候选疗法AZD8601;默沙东也宣布退还Moderna其靶向KRAS的癌症疫苗mRNA-5671的全部权益。总结整体来说,mRNA肿瘤疫苗项目的进度是要更快一点,已经有多款项目挺进II期临床。mRNA在肿瘤治疗领域正处于一个高速发展的阶段,很多项目才起步,未有更多临床数据。但是鉴于mRNA技术的优势,以及mRNA疫苗在新冠疫情中发挥出的巨大作用,mRNA未来在肿瘤治疗领域中的潜力可期。参考资料:1.各公司官网近期热门视频更多精彩视频,尽在佰傲谷视频号,欢迎关注~本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀ 点亮在看,传递信息♥
100 项与 PGV002 mRNA vaccine(NeoCura Bio-Medical Technology) 相关的药物交易