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
个性化肿瘤疫苗结合pembrolizumab免疫检查点抑制剂在结直肠癌患者中取得显著疗效
Personalized tumor vaccines combined with pembrolizumab demonstrate significant efficacy in colorectal cancer patients
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
未报告严重不良事件，患者耐受性良好
No serious adverse events reported; excellent patient tolerance
• 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 | 80% (4/5) | 50% (8/16) | ||
| 表位阳性率 | Epitope Positivity | 19.6% (11/56) | 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
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