突破性临床试验结果，展示个性化肿瘤疫苗的卓越疗效
Breakthrough clinical trial results demonstrating exceptional efficacy of personalized tumor vaccines
个性化肿瘤mRNA疫苗联合免疫检查点抑制剂，在晚期实体瘤患者中取得突破性疗效，DCR 100%、0%≥3级不良事件
Personalized mRNA cancer vaccine combined with checkpoint inhibitors — breakthrough efficacy in advanced solid tumors, DCR 100%, 0% Grade 3+ AE
南京大学医学院 PI: 张峻峰
Nanjing University School of Medicine | Principal Investigator: Prof. Zhang Junfeng
• Pembrolizumab 200mg IV q3w ×6次
• Neoantigen疫苗 100μg/次，超声引导下腹股沟淋巴结注射
• 前七针：每周一次
• 后续针次：每三周一次
• Pembrolizumab 200mg IV every 3 weeks ×6 doses
• Neoantigen vaccine 100μg per dose via ultrasound-guided inguinal lymph node injection
• First 7 injections: weekly
• Subsequent doses: every 3 weeks
0% ≥3级TEAE、0% SAE、0% DLT，m1ψ修饰后发热率从100%降至0%
0% Grade 3+ TEAE, 0% SAE, 0% DLT; m1ψ modification reduced fever from 100% to 0%
• 初诊：无特效药可用
• 治疗：停药后转移灶持续缩小
• 疗效：肿瘤缩小50%
• Initial: No effective standard therapy
• Response: Continuous shrinkage post-treatment
• Outcome: 50% tumor reduction
• 初诊：肺内多发转移灶
• 治疗：个性化疫苗+免疫检查点抑制剂
• 疗效：转移灶完全消失
• Initial: Multiple lung metastases
• Treatment: Personalized vaccine + immunotherapy
• Outcome: Complete resolution of metastases
• 初诊：肝脏多发转移，标志物升高
• 治疗：个性化疫苗诱导免疫应答
• 疗效：肿瘤标志物降至正常
• Initial: Multiple hepatic metastases, elevated markers
• Treatment: Vaccine-induced immune response
• Outcome: Tumor markers normalized
| 技术参数 | Technology Parameter | 澄实生物 | TheraRNA | BioNTech |
|---|---|---|---|---|
| 测序技术 | Sequencing | 全长三代 | Long-read 3rd gen | 短读长二代 | Short-read 2nd gen | ||
| 捕获方案 | Capture | 翻译组 | Translatome | WES + RNAseq | ||
| 抗原预测 | Antigen Prediction | MHC I + II | MHC I only | ||
| 患者响应率 | Patient Response | 83.3% (5/6) | 50% (8/16) | ||
| 表位阳性率 | Epitope Positivity | 17.5% (14/80) | 10.4% (25/240) |
突破性使用三代长读长测序技术，捕获完整的细胞翻译组信息
Breakthrough use of long-read sequencing to capture complete translatome information
结合深度学习算法，精准预测MHC I和MHC II呈递的表位
Deep learning algorithms for accurate MHC I and II epitope prediction
从根源解决肿瘤疫苗表位不够、不准的痛点
Addresses fundamental challenge of tumor vaccine epitope quantity and accuracy
结果已发表于Science Advances (IF>17)，获得学术认可
Results published in Science Advances (IF>17), earning academic recognition
如果您或您的家人正在寻找新的肿瘤治疗方案，了解我们的个性化疫苗临床试验
If you or your family are seeking new cancer treatment options, learn about our personalized vaccine clinical trials
清除微小病灶，抑制转移复发
Eliminate minimal residual disease and prevent recurrence
将"减瘤手术"转化为"根治手术"，显著提高长期生存率
Transform cytoreductive surgery into curative treatment, significantly improving long-term survival
治疗骨关节感染的创新免疫疗法
Innovative immunotherapy for bone and joint infections
机构：上海仁济医院
适应症：骨关节感染治疗
时间：2026年1月
Site: Shanghai Renji Hospital
Indication: Bone & Joint Infection Treatment
Timeline: Jan 2026
状态：计划备案
预计时间：2026年12月
下一步：申报关键临床试验
Status: Planned filing
Timeline: Dec 2026
Next Step: Key clinical trial initiation
预计时间：~2029年
目标：新型生物制品批准
市场：全球骨科感染治疗市场
Timeline: ~2029
Target: Novel biologics approval
Market: Global orthopedic infection market
了解更多：详细的临床前数据和开发进展
Learn More: Detailed preclinical data and development progress
查看管线详情 View Pipeline Details