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更新于：2025-12-12
YSCH-01
重组L-IFN腺病毒(上海元宋)
更新于：2025-12-12
概要
基本信息
原研机构 |
在研机构 |
非在研机构 |
权益机构- |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)临床1期 |
特殊审评- |
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关联
4
项与 重组L-IFN腺病毒(上海元宋) 相关的临床试验ChiCTR2400092993
An open-label, single-center, multi-dose exploratory clinical study assessing the safety, tolerability, and initial efficacy of YSCH-01 monotherapy or in combination with Atezolizumab for the treatment of relapsed Glioblastoma (GBM).
CTR20241362
一项在晚期实体瘤受试者中评估YSCH-01瘤内注射的安全性/耐受性和初步疗效的开放、单/多次给药剂量递增及剂量扩展临床研究
NCT05180851
Safety and Efficacy of Recombinant L-IFN Adenovirus Injection in Relapsed/Refractory Solid Tumors: a Single/Multicenter, Dose-increasing, Cohort Extension Clinical Study
100 项与 重组L-IFN腺病毒(上海元宋) 相关的临床结果
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100 项与 重组L-IFN腺病毒(上海元宋) 相关的转化医学
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100 项与 重组L-IFN腺病毒(上海元宋) 相关的专利（医药）
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3
项与 重组L-IFN腺病毒(上海元宋) 相关的文献（医药）2025-06-01PHARMACEUTICAL RESEARCH
Preclinical Toxicity Study and Tissue Distribution of YSCH- 01 Injection via Intratumoral Injection, Intravenous Injection, and Intraperitoneal Injection in Syrian Hamsters
Article
作者: Fang, Xian-Long ; Chen, Ruoyu ; Raza, Hafiz Khuram
BACKGROUND:
Recombinant L-IFN Adenovirus (YSCH-01) is a modified oncolytic adenovirus, which showed good curative effects in a variety of solid tumors. The safety of YSCH-01 needs to be evaluated for non-clinical research.
METHODS:
This toxicity and distribution study of YSCH-01 injection via ITU/IV/IP injection in Syrian Hamster was conducted to prepare an investigational new drug (IND) application. The endpoints included mortality/moribundity, clinical observation, body weight, palpable mass examination, food consumption, ophthalmology, and clinical pathology. Toxicokinetics, ADA test, viral shedding, and tissue bio-distribution were analyzed.
RESULTS:
The severely toxic dose in 10% of animals was 1 × 1011 VP/animal, > 2 × 1011 VP/kg, and 6.7 × 1011 VP/kg for ITU groups, IV groups and IP groups, respectively. The antibody titers of recombinant L-IFN adenovirus were significantly increased following YSCH-01 administration, and slightly lower during recovery period. YSCH-01 gDNA can be shed through the administration site, saliva and feces, and almost no urine. In the ITU, IV, and IP injection groups, YSCH-01 was distributed in the whole blood and all collected organs with Tmax in most whole blood/tissues of 2.00-4.00 days and L-IFN was detected in all tumor and serum samples, with a Tmax of 2.00-4.00 days, full or partial clearance of YSCH-01 and L-IFN was noted in most tissues/organs or tumor and serum on D28.
CONCLUSIONS:
Our study demonstrated the toxicity and potential toxicity of YSCH-01 in Syrian hamsters and evaluated its tissue distribution in hamsters after a single administration. STD10 results in hamsters support the safety of the estimated dosage for future clinical studies.
2023-01-01Neuro-oncology advances
Double-modified oncolytic adenovirus armed with a recombinant interferon-like gene enhanced abscopal effects against malignant glioma
Article
作者: Xu, Hou-Shi ; Cao, Xue-Ping ; Jiang, Shan ; Li, Tian-Wen ; Liu, Xin-Yuan ; Zhang, Kang-Jian ; Chai, Hui-Hui ; Shi, Zhi-Feng ; Fang, Xian-Long ; Wu, Zan-Yi ; Gu, Jin-Fa ; Tang, Qi-Sheng ; Zhou, Liang-Fu
Abstract:
Background:
The development of new therapies for malignant gliomas has been stagnant for decades. Through the promising outcomes in clinical trials of oncolytic virotherapy, there is now a glimmer of hope in addressing this situation. To further enhance the antitumor immune response of oncolytic viruses, we have equipped a modified oncolytic adenovirus (oAds) with a recombinant interferon-like gene (YSCH-01) and conducted a comprehensive evaluation of the safety and efficacy of this modification compared to existing treatments.
Methods:
To assess the safety of YSCH-01, we administered the oAds intracranially to Syrian hamsters, which are susceptible to adenovirus. The efficacy of YSCH-01 in targeting glioma was evaluated through in vitro and in vivo experiments utilizing various human glioma cell lines. Furthermore, we employed a patient-derived xenograft model of recurrent glioblastoma to test the effectiveness of YSCH-01 against temozolomide.
Results:
By modifying the E1A and adding survivin promoter, the oAds have demonstrated remarkable safety and an impressive ability to selectively target tumor cells. In animal models, YSCH-01 exhibited potent therapeutic efficacy, particularly in terms of its distant effects. Additionally, YSCH-01 remains effective in inhibiting the recurrent GBM patient-derived xenograft model.
Conclusions:
Our initial findings confirm that a double-modified oncolytic adenovirus armed with a recombinant interferon-like gene is both safe and effective in the treatment of malignant glioma. Furthermore, when utilized in combination with a targeted therapy gene strategy, these oAds exhibit a more profound effect in tumor therapy and an enhanced ability to inhibit tumor growth at remote sites.
NEURO-ONCOLOGY
IL-8-Induced Tumor Self-Rampart Spatially Confines Oncolytic Virotherapy in Glioblastoma
Article
作者: Tang, Qisheng ; Zhu, Ruize ; Wu, Zanyi ; Shi, Zhifeng ; Jiang, Shan ; Fan, Zhen ; Wang, Yue ; Ping, Yifang ; Liu, Beining ; Yan, Songlin ; Sun, Maoyuan ; Chai, Huihui ; Xu, Houshi ; Chen, Jiawen ; Zhou, Zhirui ; Yang, Bojie ; Ping, Weiqiu ; Li, Tianwen ; Wang, Xin ; Zeng, Yulai ; Guan, Yun ; Zhou, Liangfu ; Teng, Yanlin ; Xu, Yongfen ; Zhang, Kangjian ; Li, Zhen
Abstract:
Background:
Oncolytic virotherapy holds promise for glioblastoma, but the intratumoral replication kinetics of oncolytic viruses and resistance mechanisms of tumor cells remain poorly understood, limiting the development of precise combinssation strategies to improve durable efficacy.
Methods:
Using the translational RESCUE framework that synchronizes clinical trials with patient-derived xenograft (PDX) models, we profiled the replication kinetics of the oncolytic adenovirus YSCH-01 and performed genome-wide CRISPR activation screening to identify key genes restricting sustained viral replication. Through spatial transcriptomics combined with histological analyses, we delineated the spatial determinants that limit viral dissemination following oncolytic virus administration.
Results:
We identified BCL10 as a key suppressor of sustained viral replication. Viral infection activated the BCL10–NF-κB pathway, triggering paracrine secretion of interleukin-8 (IL-8) from infected tumor cells. IL-8 induced senescence and fibrotic remodeling in neighboring uninfected cells, forming a previously unrecognized Tumor Self-Rampart (TSR)—a concentric barrier of senescent and fibrotic tumor cells that spatially confines viral propagation. TSR was validated in both PDX and patient tumors. IL-8 blockade with Reparixin or peri-dosing glucocorticoids effectively disrupted TSR formation, prolonged viral persistence, and enhanced therapeutic efficacy.
Conclusion:
Glioblastoma mounts a spatial self-protective defense through IL-8–driven TSR formation that restricts oncolytic virus spread. IL-8 functions as both a pharmacodynamic biomarker and a therapeutic target, and its inhibition provides a rational strategy to overcome resistance and optimize GBM virotherapy.
100 项与 重组L-IFN腺病毒(上海元宋) 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 晚期恶性实体瘤 | 临床1期 | 中国 | 2024-06-17 | |
| 复发性胶质母细胞瘤 | 临床1期 | 中国 | - | 2023-06-27 |
| 膀胱癌 | 临床1期 | 中国 | 2021-11-30 | |
| 乳腺癌 | 临床1期 | 中国 | 2021-11-30 | |
| 头颈部肿瘤 | 临床1期 | 中国 | 2021-11-30 | |
| 肺癌 | 临床1期 | 中国 | 2021-11-30 | |
| 黑色素瘤 | 临床1期 | 中国 | 2021-11-30 | |
| 卵巢癌 | 临床1期 | 中国 | 2021-11-30 | |
| 宫颈癌 | 临床1期 | 中国 | 2021-11-30 | |
| 非小细胞肺癌 | 临床申请批准 | 中国 | 2024-04-15 |
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临床结果
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适应症
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早期临床1期 | 13 | 憲繭鹹構餘淵繭膚願艱(窪艱網糧憲壓齋窪窪鏇) = 製夢衊餘壓憲壓繭襯醖 淵壓淵衊膚築積觸夢壓 (願膚夢繭構憲襯蓋選鑰 ) 更多 | 积极 | 2024-05-08 |
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