ISA-101(ISA-101) - 在研适应症：转移性宫颈癌，复发性宫颈癌，人乳头瘤病毒 16 阳性_专利_临床

概要

基本信息

药物类型

通用抗原疫苗、治疗性疫苗

别名

HPV-SLP、Human papilloma virus type 16 E6/E7 synthetic long peptides、ISA-HPV

+ [9]

靶点-

作用机制

免疫刺激剂

治疗领域

肿瘤感染口颌疾病+ [3]

在研适应症

转移性宫颈癌复发性宫颈癌人乳头瘤病毒 16 阳性+ [4]

非在研适应症

唇肿瘤鳞状细胞癌外阴上皮内瘤变

原研机构

ISA Pharmaceuticals BV

在研机构

Regeneron Pharmaceuticals, Inc.

ISA Pharmaceuticals BV

The University of Texas MD Anderson Cancer Center

+ [2]

非在研机构

Pfizer Inc.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评快速通道 (美国)

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关联

9

项与 ISA-101 相关的临床试验

NCT04713046 / Recruiting临床1/2期IIT

A Phase I Clinical Trial Assessing the Safety, Feasibility and Immunologic Correlates of Allogeneic HPV-specific Cluster of Differentiation 4 (CD4)+ T Cells in Advanced HPV16-associated Malignancies

In this study, haploidentical relatives of a patient with recurrent or metastatic HPV 16-associated malignancy will be vaccinated with a therapeutic human papillomavirus (HPV) vaccine series to generate HPV-specific leukocytes. The cancer patient with recurrent or metastatic HPV16+ cancer will then be randomized to one of two arms: 1) non-myeloablative allogeneic bone marrow transplant or 2) cluster of differentiation 8 (CD8)-depleted donor lymphocyte infusion.

开始日期2023-10-18

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT05132803 / Withdrawn临床1期IIT

A Feasibility Trial to Assess Intratumoral Injection of TA-CIN With Anti-PD-1 Therapy for Recurrent HPV16-associated Cancers

The primary to assess the safety and tolerability of TA-CIN and anti-PD-1 therapy in patients with recurrent HPV16-associated cancers and to assess the feasibility of IT injection of TA-CIN in patients with recurrent HPV16-associated cancers undergoing treatment with anti-PD-1 therapy.

开始日期2021-08-01

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

NCT04398524 / Active, not recruiting临床2期

A Phase II Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Positive Oropharyngeal Cancer Who Have Experienced Disease Progression With Prior Anti-PD-1 Therapy

This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

开始日期2021-07-01

申办/合作机构

ISA Pharmaceuticals BV

[+1]

100 项与 ISA-101 相关的临床结果

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100 项与 ISA-101 相关的转化医学

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100 项与 ISA-101 相关的专利（医药）

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114

项与 ISA-101 相关的文献（医药）

2025-01-01·FOOD CHEMISTRY

Modification of soybean lipophilic protein based on pH-shifting and high-pressure homogenization: Focus on structure, physicochemical properties and delivery vehicle

Article

作者: Gao, Yiting ; Chi, Huiyue ; Gao, Tian ; Li, Lijia ; Teng, Fei

High-pressure homogenization and pH-shifting can be used to modify soybean lipophilic protein (SLP), and to enhance its ability to deliver vitamin B₁₂. The structural changes of SLP were analyzed by multispectral techniques and the results showed that secondary and tertiary structures of SLP were altered by modification. The modification unfolded the SLP structure, released more free hydrogen ions, and increased positive charge density on the protein surface. Also, the solubility of modified SLP increased by maximum of 34.75 %. Furthermore, molecular docking showed that complexes were formed between SLP and vitamin B₁₂ mainly through hydrogen bonding and hydrophobic interactions, and the encapsulation rate of modified SLP was maximally increased by 2.3 %. In vitro digestion showed that modified SLP enhanced stability and bioaccessibility of vitamin B₁₂. This study provides theoretical basis for modification of SLP and effective delivery of bioactive substances.

2024-10-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Sparassis latifolia polysaccharide alleviated lipid metabolism abnormalities in kidney of lead-exposed mice by regulating oxidative stress-mediated inflammation and autophagy based on multi-omics

Article

作者: Chang, Mingchang ; Feng, Cuiping ; Yun, Shaojun ; Cheng, Feier ; Liu, Jingyu ; Meng, Junlong ; Ai, Honghu ; Lu, Xingru ; Wu, Shanshan ; Cheng, Yanfen ; Cao, Jinling ; Wu, Rui

Lead is a common environmental pollutant which can accumulate in the kidney and cause renal injury. However, regulatory effects and mechanisms of Sparassis latifolia polysaccharide (SLP) on lipid metabolism abnormality in kidney exposed to lead are not clarified. In this study, mice were used to construct an animal model to observe the histopathological changes in kidney, measure lead content, damage indicators, differentially expressed metabolites (DEMs) and genes (DEGs) in key signaling pathways that cause lipid metabolism abnormalities based on lipidomics and transcriptomics, which were later validated using qPCR and western blotting. Co-treatment of Pb and N-acetylcysteine (NAC) were used to verify the link between SLP and oxidative stress. Our results indicated that treatment with SLP identified 276 DEMs (including metabolism of glycerophospholipid, sphingolipid, glycerolipid and fatty acid) and 177 DEGs (including genes related to oxidative stress, inflammation, autophagy and lipid metabolism). Notably, regulatory effects of SLP on abnormal lipid metabolism in kidney were mainly associated with oxidative stress, inflammation and autophagy; SLP could regulate abnormal lipid metabolism in kidney by reducing oxidative stress and affecting its downstream-regulated autophagy and inflammatory to alleviate renal injury caused by lead exposure. This study provides a theoretical basis for SLP intervention in lead injury.

2024-04-01·Materials today. Bio

Multi-functional composite dressings with sustained release of MSC-SLP and anti-adhesion property for accelerating wound healing

Article

作者: Wang, Ziran ; Li, Xinxin ; He, Falian ; Duan, Wu ; Yan, Peng ; Hou, Xinguo ; Chen, Li ; Wang, Haipeng ; Liu, Fuqiang ; Guan, Yingchun ; Ren, Zhongjing ; Li, Shaomin

Exudate management is of significant clinical value for the treatment of acute wound. Various wound dressings have been developed to restore the function of injured tissues and promote wound healing, but proper exploiting the healing factors inside exudate and achieving anti-adhesion wound care remains a challenge. Herein, we present a novel multi-functional composite dressing (MCD) by coupling supernatant lyophilized powder of mesenchymal stem cells (MSC-SLP) with a sandwich-structured wound dressing (SWD). The developed MCDs demonstrated unique unidirectional drainage capability, stable anti-adhesion characteristics, and improved wound healing performance. The designed SWD with both superhydrophobic inner surface and liquid-absorption ability of mid layer enables the dressings exhibit desired anti-adhesion property to neoformative granulation tissues, favorable shielding effect to exogenous bacteria, as well as appropriate exudate-retaining capability and unidirectional exudate-absorption property. The introduction of MSC-SLP in SWD was demonstrated to further improve wound healing quality. Compared to medical gauze, the synergic effect of SWD and MSC-SLP significantly accelerates wound healing rate by over 30%, avoids tissue avulsion when changing dressings, and produces a flat-smooth closure surface. More importantly, the wound treated with MCDs presents more skin accessory organs and blood vessels in regenerated tissues than other groups. In vivo/vitro biocompatibility evaluations indicated little toxicity, demonstrating the biosecurity of the developed dressings. The proposed method offers great potential in clinical applications particularly for chronic wound treatments.

110

项与 ISA-101 相关的新闻（医药）

2024-11-13

·药明康德

疾病控制率达80%的抗癌免疫组合疗法，诺华与Schrödinger达超24亿美元研发合作……

▎药明康德内容团队编辑 80%患者疾病得到控制，创新免疫组合疗法2期临床结果公布 HOOKIPA Pharma日前宣布，在第39届癌症免疫治疗学会（SITC2024）年会上，展示了评估eseba-vec联合pembrolizumab作为一线疗法治疗人乳头瘤病毒16型阳性（HPV16+）复发或转移性头颈部鳞状细胞癌（R/M HNSCC）的2期临床数据。该海报展示了一个表达PD-L1患者亚组的结果（CPS>20，n=27）。截至2024年9月30日，数据显示eseba-vec表现出52%的总缓解率（ORR）和80%的疾病控制率（DCR）。尽管无进展生存期（PFS）和总生存期（OS）数据尚未成熟，但初步中位PFS已超过16个月，12个月总生存率为83%，且66.7%的确认缓解患者仍在持续接受治疗。 Eseba-vec（也称为HB-200）是一种正在针对HPV16阳性癌症进行评估的在研免疫疗法，基于HOOKIPA的专有沙粒病毒平台开发，表达具有HPV16中高度免疫原性的E7E6融合蛋白。在小鼠模型中，它具有强力免疫原性，可激发抗肿瘤免疫反应。诺华与Schrödinger达成超24亿美元研发合作 Schrödinger今日宣布与诺华（Novartis）达成一项研究合作与许可协议，Schrödinger与诺华将整合现有的研究工作，以发现并推进诺华核心治疗领域中针对未公开靶点的在研疗法。协议旨在推进多个候选药物供诺华进行开发和商业化。Schrödinger与诺华将共同负责发现候选药物的工作，而诺华将负责临床开发、生产和全球商业化。同时双方还宣布扩大为期3年的软件协议，这将大幅增加诺华对Schrödinger计算预测建模技术和企业信息平台的访问权限。诺华可以在其各研究站点中部署Schrödinger的全套药物发现技术。Schrödinger将提供全面支持，确保平台的完全整合与优化，使诺华能够快速在药物发现项目中大规模应用计算技术。根据协议条款，诺华将向Schrödinger支付1.5亿美元的预付款。此外，Schrödinger还有资格获得高达8.92亿美元的研究、开发和监管里程碑付款，以及高达13.8亿美元的商业里程碑付款。剑指帕金森病，GSK达成超6亿美元研发合作 Vesalius Therapeutics公司今日宣布与GSK达成多靶点战略合作，以发现和开发治疗帕金森病及另一未公开的神经退行性疾病的创新疗法。Vesalius将利用其平台来识别帕金森病及另一神经退行性疾病中的新型干预靶点，GSK将拥有选择权来推进针对这些创新靶点的项目。此外，GSK将获得Vesalius公司的一款临床前小分子项目的全球开发和商业化权利，该项目最初聚焦于帕金森病。 Vesalius利用大规模人类遗传学、诱导多能干细胞（iPSC）模型和人工智能技术来发现创新干预靶点，以推动新疗法的开发。根据协议条款，GSK将负责推进Vesalius的临床前小分子项目，最初聚焦于帕金森病，并有选择权推进针对帕金森病及另一神经退行性适应症中所发现的创新靶点的研发项目。GSK将进行所有开发和商业化工作。Vesalius将获得8000万美元的前期付款和股权投资，并有资格获得最多5.7亿美元的潜在临床前、开发及商业化里程碑付款。此外，对于该多靶点合作中的每个创新靶点，Vesalius也有资格获得临床前、开发及商业化里程碑付款。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Vesalius Announces Multi-Target Strategic Alliance with GSK to Develop Breakthrough Treatments for People Afflicted with Parkinson's Disease. Retrieved November 12, 2024, from https://www.prnewswire.com/news-releases/vesalius-announces-multi-target-strategic-alliance-with-gsk-to-develop-breakthrough-treatments-for-people-afflicted-with-parkinsons-disease-302301349.html [2] Schrödinger Announces Multi-Target Collaboration and Expanded Software Licensing Agreement with Novartis. Retrieved November 12, 2024, from https://www.businesswire.com/news/home/20241112425300/en [3] HOOKIPA Pharma’s Eseba-vec Highlighted in SITC Late-Breaker. Retrieved November 12, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978565/0/en/HOOKIPA-Pharma-s-Eseba-vec-Highlighted-in-SITC-Late-Breaker.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

引进/卖出免疫疗法临床2期

2024-11-12

·Pharma CMC

石药创新：HPV治疗性疫苗获批临床

刚刚，石药创新制药发布公告，其控股子公司石药集团巨石生物于近日收到国家药品监督管理局核准签发的关于治疗性疫苗SYS6026的《药物临床试验批准通知书》，同意开展人乳头瘤病毒（HPV）16/18型相关高级别鳞状上皮内病变（HSIL）患者的临床试验。 SYS6026是基于石药创新mRNA平台自主开发的首款治疗性疫苗，由信使RNA（mRNA）分子结合脂质纳米粒（LNP）递送系统组成。该产品通过mRNA表达HPV16或18型的E6和E7抗原，诱导机体产生特异性T细胞免疫应答，进而清除HPV感染的细胞并阻断癌变过程。当前的临床治疗手段主要以手术为主，存在对患者伤害大且易复发的缺点。该产品作为一种高效的非手术型治疗方案，有望填补该领域的重大临床需求，具备较高的临床开发价值。截至目前，全球范围内尚未有HPV治疗性疫苗上市。本次获批的临床适应症为人乳头瘤病毒（HPV）16/18型相关高级别鳞状上皮内病变（HSIL）的治疗。免费报名中

信使RNA疫苗上市批准临床申请

2024-11-11

·沃森生物

沃森生物第七届进博会发布加速消除宫颈癌创新防控体系

本文转载自人民日报健康客户端 11月9日，在第七届进博会上，沃森生物与合作伙伴在进博会创新孵化专区共同推出加速消除宫颈癌创新防控体系实景展。沃森双价HPV疫苗于2022年上市，主要用于预防因高危型HPV16、18型所致的相关疾病。宫颈癌是目前唯一可以通过接种疫苗预防的癌症，越早接种，效果越佳，在感染HPV之前尽早接种HPV疫苗尤为重要，在我国，超过84.5%的宫颈癌与HPV16和HPV18感染相关。责编：呼梦瑶主编：田茹校对：陈龙飞点击文末“阅读原文”查看新闻链接

疫苗

100 项与 ISA-101 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性宫颈癌	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2021-06-28
转移性宫颈癌	临床2期	比利时	Regeneron Pharmaceuticals, Inc.	2021-06-28
转移性宫颈癌	临床2期	巴西	Regeneron Pharmaceuticals, Inc.	2021-06-28
转移性宫颈癌	临床2期	意大利	Regeneron Pharmaceuticals, Inc.	2021-06-28
转移性宫颈癌	临床2期	荷兰	Regeneron Pharmaceuticals, Inc.	2021-06-28
转移性宫颈癌	临床2期	俄罗斯	Regeneron Pharmaceuticals, Inc.	2021-06-28
转移性宫颈癌	临床2期	韩国	Regeneron Pharmaceuticals, Inc.	2021-06-28
转移性宫颈癌	临床2期	西班牙	Regeneron Pharmaceuticals, Inc.	2021-06-28
鳞状细胞癌	临床2期	比利时	-	2021-02-15
口咽部鳞状细胞癌	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2018-11-30

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04646005 (CTgov)	临床2期	复发性宫颈癌 \| 转移性宫颈癌	113	Cemiplimab+ISA 101b	獵艱窪觸顧製獵窪鬱製(壓蓋積夢繭夢觸築廠醖) = 遞築襯餘艱艱齋築築遞願繭願鑰顧範夢蓋淵鑰 (繭壓齋糧鹹壓壓襯鏇範, 蓋願鑰餘襯選淵衊夢膚 ~ 鑰憲遞鏇築選蓋壓壓廠) 更多	-	2024-09-19
NCT04646005 (ASCO2024) 人工标引	临床2期	宫颈癌二线 PD-L1	113	Cemiplimab 350 mg+ISA101b 100 µg/peptide	窪構遞夢遞製襯廠夢選(衊醖膚簾窪顧製憲選積) = 觸鬱淵鑰鹽艱窪製鑰遞範餘製繭鹹遞選糧網鹽 (鑰選觸齋醖淵艱艱簾觸, 9.9 ~ 23.7) 更多	积极	2024-05-24
NCT03669718 (OpcemISA, ASCO2024)	临床2期	HPV16阳性口咽癌 HPV16-positive	198	ISA101b + cemiplimab	構鏇遞夢觸夢憲夢鹹顧(顧製蓋夢範範觸繭齋觸) = 鹽廠廠艱鹹鬱夢窪壓鹹觸鹽網醖範鏇醖夢襯蓋 (鹹築願壓鏇獵蓋築淵繭 ) 更多	积极	2024-05-24
NCT03669718 (OpcemISA, ASCO2024)	临床2期	HPV16阳性口咽癌 HPV16-positive	198	Placebo + cemiplimab	構鏇遞夢觸夢憲夢鹹顧(顧製蓋夢範範觸繭齋觸) = 鏇鹽繭繭積艱獵築糧顧觸鹽網醖範鏇醖夢襯蓋 (鹹築願壓鏇獵蓋築淵繭 ) 更多	积极	2024-05-24
NCT03669718 (OpcemISA , PRNewswire) 人工标引	临床2期	口咽肿瘤	199	ISA101b+Cemiplimab	選壓觸廠鑰襯夢願選鏇(構遞糧構遞簾膚淵窪廠) = not meet in the entire population 窪壓選選構醖鬱壓鹹積 (襯觸觸範醖選餘觸壓構 ) 未达到更多	不佳	2023-12-12
NCT03669718 (OpcemISA , PRNewswire) 人工标引	临床2期	口咽肿瘤	199	Placebo+Cemiplimab		不佳	2023-12-12
NCT04398524 (ASCO2023) 人工标引	临床2期	HPV16阳性口咽癌二线 HPV16 Positive	26	ISA101b 100µg/peptide+cemiplimab 350mg	壓構築積網獵夢製鬱網(夢獵鹹遞夢齋壓蓋糧築) = 繭遞範鬱夢繭鹹壓顧築蓋遞艱憲夢鏇網衊艱壓 (製顧餘顧顧鏇蓋鏇鹽觸 ) 更多	积极	2023-05-31
NCT02426892 (CTgov)	临床2期	实体瘤 \| 人乳头瘤病毒 16 阳性	33	ISA101 Vaccine+Nivolumab	餘積蓋鹽製選艱糧艱蓋(範選襯範憲繭鹽蓋鹹憲) = 壓簾壓憲夢艱壓繭糧構範淵艱遞鹽遞醖構糧願 (淵積網選壓膚艱窪遞醖, 鑰願願選遞餘繭範選簾 ~ 壓鏇構範製廠築齋顧憲) 更多	-	2023-04-18
NCT03258008 (CTgov)	临床2期	HPV16阳性口咽癌 \| 唇肿瘤	3	Utomilumab	淵夢糧願顧觸壓夢積製(鑰淵鹹窪觸製鹽夢膚夢) = 鬱顧艱觸艱憲憲壓鏇壓壓蓋鹹鏇艱繭糧選衊範 (膚鑰襯築衊淵積壓蓋襯, 簾積廠衊糧願膚範壓願 ~ 膚簾餘夢憲淵構遞蓋構) 更多	-	2022-12-16
NCT02426892 (Pubmed \| J Immunother Cancer) 人工标引	临床2期	人乳头瘤病毒 16 阳性 HPV-16 positive	24	Nivolumab+ISA 101	製觸鹽夢糧構網夢蓋鹽(餘顧膚獵窪鹽襯廠築鹹) = 網壓範鹽夢繭夢壓遞獵餘遞鏇廠餘鏇製簾鑰繭 (糧範壓壓網蓋膚壓範鬱 ) 更多	积极	2022-02-01
NCT02128126 (Pubmed \| Sci Transl Med) 人工标引	临床1/2期	肿瘤	72	ISA 101	簾鹹艱獵衊鹽顧繭遞鏇(鬱簾鹽糧選齋糧製廠鏇) = 衊膚齋製蓋獵壓鑰鏇窪觸觸糧襯鑰膚網襯遞鹹 (鑰構蓋顧願憲顧網築選 )	积极	2020-03-18
P157 (SITC2018)	临床2期	人乳头瘤病毒 16 阳性 CD3+CD8+PD-1+ \| CD68+PD-L1- \| CD68+PD-L1+ ... 更多	24	ISA101	網選築衊鬱淵鹹糧艱夢(鹽衊衊鑰襯襯壓繭醖選) = 獵鏇憲壓簾餘衊顧範鏇糧築醖觸構築窪襯網膚 (齋淵鬱夢醖憲鹽齋網壓 ) 更多	积极	2018-11-06