A Phase 2, Multicenter, Open-Label Study of SCIB1 in Patients with Advanced Unresectable Melanoma Receiving Pembrolizumab - SCIB1 in melanoma patients receiving pembrolizumab SCIB1-002

开始日期2019-01-24

申办/合作机构

Scancell Ltd.

NCT01138410

/ Terminated临床1/2期

A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma

The study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma. SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human cells. The antibody modifications are designed to stimulate the patient's immune T cells to have a strong and specific reaction against melanoma cells which should then be eliminated. SCIB1 is injected into muscle using a device which simultaneously delivers an electrical impulse to enhance the transfer of SCIB1 into muscle cells. The trial will assess the safety and tolerability of SCIB1, the safety and performance of the injection device and the immunological effects of SCIB1. This is the first study of SCIB1 in humans and the trial has two parts, in the first part the dose will be escalated to determine a safe and tolerable level up to a maximum of 8 mg per dose. In the second part patients will receive the dose determined in the first part. Patients will have stage III or IV melanoma, be HLA type A2 and have a life expectancy of at least three months. All patients will receive 5 injections of SCIB1 over 5.5 months. At the discretion of the investigator, patients may continue to receive SCIB1 at 3-6 month intervals for 5 years. The study will be conducted at major cancer centres in the UK only and is expected to last for seven years. Patients will be followed up for five years after they have completed the trial.

开始日期2010-05-01

申办/合作机构

Scancell Ltd.

100 项与 Melanoma vaccine TRP2 gp100(Scancell Ltd.) 相关的临床结果

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100 项与 Melanoma vaccine TRP2 gp100(Scancell Ltd.) 相关的转化医学

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100 项与 Melanoma vaccine TRP2 gp100(Scancell Ltd.) 相关的专利（医药）

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项与 Melanoma vaccine TRP2 gp100(Scancell Ltd.) 相关的文献（医药）

2018-06-03·Oncoimmunology2区 · 医学

Targeting gp100 and TRP-2 with a DNA vaccine: Incorporating T cell epitopes with a human IgG1 antibody induces potent T cell responses that are associated with favourable clinical outcome in a phase I/II trial

2区 · 医学

ArticleOA

作者: Daniels, Ian ; Elsheikh, Somaia ; Gijon, Mohamed ; Ottensmeier, Christian H. ; Hannaman, Drew ; Mulatero, Clive ; Pandha, Hardev ; Brentville, Victoria A. ; Lorigan, Paul ; Metheringham, Rachael L. ; Durrant, Lindy G. ; Cunnell, Michelle ; Villasanti, Naty ; Adams, Sally E. ; Machado, Lee ; Patel, Poulam M. ; Hadjimichael, Efthymios ; Plummer, Ruth

A DNA vaccine, SCIB1, incorporating two CD8 and two CD4 epitopes from TRP-2/gp100 was evaluated in patients with metastatic melanoma. Each patient received SCIB1 via intramuscular injection with electroporation. The trial was designed to find the safest dose of SCIB1 which induced immune/clinical responses in patients with or without tumour. Fifteen patients with tumor received SCIB1 doses of 0.4-8 mg whilst 20 fully-resected patients received 2-8 mg doses. Twelve patients elected to continue immunization every 3 months for up to 39 months. SCIB1 induced dose-dependent T cell responses in 88% of patients with no serious adverse effects or dose limiting toxicities. The intensity of the T cell responses was significantly higher in patients receiving 4 mg doses without tumor when compared to those with tumor (p < 0.01). In contrast, patients with tumor showed a significantly higher response to the 8 mg dose than the 4 mg dose (p < 0.03) but there was no significant difference in the patients without tumor. One of 15 patients with measurable disease showed an objective tumor response and 7/15 showed stable disease. 5/20 fully-resected patients have experienced disease recurrence but all remained alive at the cut-off date with a median observation time of 37 months. A positive clinical outcome was associated with MHC-I and MHC-II expression on tumors prior to therapy (p = 0.027). We conclude that SCIB1 is well tolerated and stimulates potent T cell responses in melanoma patients. It deserves further evaluation as a single agent adjuvant therapy or in combination with checkpoint inhibitors in advanced disease.

2016-12-13·Oncotarget

SCIB1, a huIgG1 antibody DNA vaccination, combined with PD-1 blockade induced efficient therapy of poorly immunogenic tumors

Article

作者: Cook, Katherine W. ; Xue, Wei ; Yagita, Hideo ; Metheringham, Rachael L. ; Durrant, Lindy G. ; Symonds, Peter ; Brentville, Victoria A.

PURPOSE:

We have previously shown that supraoptimal signaling of high avidity T cells leads to high expression of PD-1 and inhibition of proliferation. This study was designed to see if this effect could be mitigated by combining a vaccine that stimulates high avidity T cells with PD-1 blockade.

EXPERIMENTAL DESIGN:

We investigated the anti-tumor effect of a huIgG1 antibody DNA vaccine (SCIB1) and PD-1 blockade.

RESULTS:

Vaccination of HLA-DR4 transgenic mice with SCIB1 induced high frequency and avidity T cell responses that resulted in survival (40%) of mice with established B16F1-DR4 tumors. SCIB1 vaccination was associated with increased infiltration of CD4 and CD8 T cells within the tumor but was also associated with upregulation of PD-L1 within the tumor environment. PD-1 blockade also resulted in increased CD8 T cell infiltration and an anti-tumor response with 50% of mice showing long term survival. In line with our hypothesis that PD-1/PD-L1 signaling results in inhibition of proliferation of high avidity T cells at the tumor site, the combination of PD-1 blockade with vaccination, enhanced the number and proliferation of the CD8 tumor infiltrate. This resulted in a potent anti-tumor response with 80% survival of the mice.

CONCLUSIONS:

There is a benefit in combining PD-1 blockade with vaccines that induce high avidity T cell responses and in particular with SCIB1.

CANCER IMMUNOLOGY IMMUNOTHERAPY

TRP-2 / gp100 DNA vaccine and PD-1 checkpoint blockade combination for the treatment of intracranial tumors

Article

作者: Hardowar, Lydia D ; Puig-Saenz, Carles ; Wainwright, Louise C ; McArdle, Stephanie E B ; Durrant, Lindy G ; Thomas, Jubini E ; Pockley, A Graham ; Ahmad, Murrium ; Tinsley, Chris J ; Brentville, Victoria A ; Pearson, Joshua R D ; McVicar, Adam M

Abstract:

Intracranial tumors present a significant therapeutic challenge due to their physiological location. Immunotherapy presents an attractive method for targeting these intracranial tumors due to relatively low toxicity and tumor specificity. Here we show that SCIB1, a TRP-2 and gp100 directed ImmunoBody® DNA vaccine, generates a strong TRP-2 specific immune response, as demonstrated by the high number of TRP2-specific IFNγ spots produced and the detection of a significant number of pentamer positive T cells in the spleen of vaccinated mice. Furthermore, vaccine-induced T cells were able to recognize and kill B16HHDII/DR1 cells after a short in vitro culture. Having found that glioblastoma multiforme (GBM) expresses significant levels of PD-L1 and IDO1, with PD-L1 correlating with poorer survival in patients with the mesenchymal subtype of GBM, we decided to combine SCIB1 ImmunoBody® with PD-1 immune checkpoint blockade to treat mice harboring intracranial tumors expressing TRP-2 and gp100. Time-to-death was significantly prolonged, and this correlated with increased CD4+ and CD8+ T cell infiltration in the tissue microenvironment (TME). However, in addition to PD-L1 and IDO, the GBM TME was found to contain a significant number of immunoregulatory T (Treg) cell-associated transcripts, and the presence of such cells is likely to significantly affect clinical outcome unless also tackled.

项与 Melanoma vaccine TRP2 gp100(Scancell Ltd.) 相关的新闻（医药）

2025-07-23

·药时空

疾病控制率近90%！癌症疫苗组合亮眼结果公布

免疫治疗公司Scancell今日公布其进行中的2期SCOPE试验的最新积极结果。该试验评估了其DNA癌症疫苗SCIB1与其改良版iSCIB1+在晚期不可切除黑色素瘤患者中的疗效，两者均与当前标准免疫检查点抑制剂联用。数据显示，接受SCIB1或iSCIB1+联合标准疗法治疗的患者（试验中的队列1和队列3）中，总缓解率（ORR）达68.6%（67例中46例），疾病控制率（DCR）为88.0%，完全缓解（CR）率为17.9%。与标准疗法在既往临床试验中约50%的ORR，以及真实世界中约48%的ORR水平相比，本次试验结果显示出显著提升。此外，SCIB1和iSCIB1+治疗组在无进展生存期（PFS）方面也表现出优势：接受SCIB1联合标准疗法治疗的队列1患者12个月无进展生存率达64.6%，接受iSCIB1+联合标准疗法治疗的队列3患者11个月无进展生存率达80.8%，而标准疗法在以往研究中的12个月无进展生存率为43.9%。安全性方面，SCIB1/iSCIB1+与标准治疗联合使用的耐受性良好，未见额外安全问题。SCIB1是Scancell DNA免疫疗法平台的首款候选药物，可激发机体免疫系统识别并清除肿瘤；而iSCIB1+则借助AvidiMab平台增强了效力，并引入更多特异性黑色素瘤抗原表位，具有覆盖更广泛患者人群的潜力。根据此试验结果，Scancell选择对iSCIB1+进行进一步开发，并正在加快规划该疗法在晚期黑色素瘤中进行全球注册研究。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

免疫疗法临床结果临床2期疫苗

2025-07-22

·药明康德

疾病控制率近90%！癌症疫苗组合亮眼结果公布；16亿美元，赛诺菲加强呼吸道疾病领域布局……

疾病控制率近90%！癌症疫苗组合亮眼结果公布免疫治疗公司Scancell今日公布其进行中的2期SCOPE试验的最新积极结果。该试验评估了其DNA癌症疫苗SCIB1与其改良版iSCIB1+在晚期不可切除黑色素瘤患者中的疗效，两者均与当前标准免疫检查点抑制剂联用。数据显示，接受SCIB1或iSCIB1+联合标准疗法治疗的患者（试验中的队列1和队列3）中，总缓解率（ORR）达68.6%（67例中46例），疾病控制率（DCR）为88.0%，完全缓解（CR）率为17.9%。与标准疗法在既往临床试验中约50%的ORR，以及真实世界中约48%的ORR水平相比，本次试验结果显示出显著提升。此外，SCIB1和iSCIB1+治疗组在无进展生存期（PFS）方面也表现出优势：接受SCIB1联合标准疗法治疗的队列1患者12个月无进展生存率达64.6%，接受iSCIB1+联合标准疗法治疗的队列3患者11个月无进展生存率达80.8%，而标准疗法在以往研究中的12个月无进展生存率为43.9%。安全性方面，SCIB1/iSCIB1+与标准治疗联合使用的耐受性良好，未见额外安全问题。SCIB1是Scancell DNA免疫疗法平台的首款候选药物，可激发机体免疫系统识别并清除肿瘤；而iSCIB1+则借助AvidiMab平台增强了效力，并引入更多特异性黑色素瘤抗原表位，具有覆盖更广泛患者人群的潜力。根据此试验结果，Scancell选择对iSCIB1+进行进一步开发，并正在加快规划该疗法在晚期黑色素瘤中进行全球注册研究。16亿美元！赛诺菲达成收购协议，加强呼吸道疾病领域布局今日，赛诺菲（Sanofi）与生物技术公司Vicebio共同宣布，两者达成总额高达16亿美元的最终收购协议，其中包括11.5亿美元的预付款以及4.5亿美元的开发与监管里程碑款项。此次收购将进一步加强赛诺菲在呼吸道病毒疫苗领域的研发布局，特别是在多价液体疫苗方面。Vicebio由Medicxi创立，专注于利用其专有的分子钳（Molecular Clamp）技术开发新一代呼吸道病毒疫苗。该技术最初由昆士兰大学发现，能够稳定病毒糖蛋白的构象，从而诱导强效的免疫保护反应，并支持高产量的液体多价疫苗制剂开发。其适用病毒包括呼吸道合胞病毒（RSV）、人偏肺病毒（hMPV）、副流感病毒、流感病毒和冠状病毒等。2024年9月，Vicebio完成B轮融资，加速其主要候选疫苗VXB-241及后续产品的临床开发。VXB-241是一款双价疫苗，靶向RSV和hMPV，主要用于预防老年人和免疫功能低下人群中的重症感染。在一项探索性1期临床试验中，该疫苗在60岁及以上成年人群中显示出良好的安全性和耐受性。超90%患者症状显著改善，反义寡核苷酸疗法有望今年上市Ionis Pharmaceuticals日前宣布，其用于治疗遗传性血管性水肿（HAE）的在研反义寡核苷酸（ASO）疗法donidalorsen在3期OASISplus研究中取得积极结果。分析显示，从既往预防性治疗方案切换至donidalorsen的患者，其平均每月HAE发作次数进一步减少62%。此外，84%的受访患者表示更偏好donidalorsen，主要原因包括疾病控制更佳、用药更便捷、注射部位不适反应更少等。研究中，患者依照预设的标准化方案从原有治疗过渡至donidalorsen，在此过程中未观察到疾病发作增加。治疗16周后，患者的平均HAE发作频率相较于既往治疗进一步显著降低。血管性水肿控制测试（AECT）评分亦显示，药物切换后报告疾病控制良好的患者比例从67%升至93%，不论使用哪种既往治疗，患者的生活质量评估也获得普遍改善。作为一种靶向前激肽释放酶（PKK）的在研ASO疗法，donidalorsen旨在通过抑制PKK的生成来预防HAE急性发作。Donidalorsen目前正在接受美国FDA的审评，以作为HAE的潜在“first-in-class”预防性治疗药物，该申请的PDUFA日期为8月21日。参考资料：[1] Scancell reports Phase 2 data showing strongly improved outcomes in Late-Stage Melanoma with its Immunobody® iSCIB1+. Retrieved July 22, 2025 from https://scancell.co.uk/wp-content/uploads/2025/07/20250722-SCOPE-Data_Press-Release-PL.pdf[2] Sanofi to acquire next-generation vaccine biotech Vicebio for US$1.6 billion. Retrieved July 22, 2025 from https://vicebio.com/sanofi-to-acquire-next-generation-vaccine-biotech-vicebio-for-us1-6-billion/[3] Phase 3 OASISplus data demonstrating benefit of donidalorsen for HAE patients who switched from other prophylactics published in JACI In Practice. Retrieved July 22, 2025 from https://ir.ionis.com/news-releases/news-release-details/phase-3-oasisplus-data-demonstrating-benefit-donidalorsen-hae免责声明：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：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

临床2期疫苗免疫疗法并购临床结果

2025-07-22

·FierceBiotech

Scancell picks winner from phase 2 cancer vaccine face-off, choosing next-gen prospect for pivotal trial

Scancell is now planning to take iSCIB1+ into a phase 2b/3 trial in patients with unresectable melanoma.\n Scancell has linked iSCIB1+ to a 69% response rate in advanced melanoma, leading the British biotech to advance the next-generation cancer vaccine candidate rather than its older sibling.The phase 2 study enrolled patients with advanced melanoma to receive either SCIB1 or iSCIB1+ on top of Bristol Myers Squibb’s aging checkpoint inhibitors Opdivo and Yervoy. Both Scancell candidates are designed to turn the immune system against tumors. The biotech modified SCIB1 to create iSCIB1+, resulting in a candidate intended to work in a wider range of melanoma patients. Tuesday, Scancell reported that the vaccines showed similar safety and efficacy in a phase 2 trial. The overall response rates in the first-line SCIB1 and iSCIB1+ cohorts were 68.4% and 68.9%, respectively. With little to choose between the candidates, Scancell picked iSCIB1+ for further development because it is suitable for use in about 80% of patients compared to just 35% to 40% for SCIB1.The biotech pooled data on SCIB1 and iSCIB1+ for a cross-trial comparison with BMS’ CheckMate-067 study. After 22 months, the rate of progression-free survival (PFS) in the pooled vaccine analysis was 69%. The result is a more than 20 percentage point improvement on the historical control, Scancell said. Further updates from the phase 2 trial are scheduled for later this year. Scancell plans to publish PFS and early overall survival data in the fourth quarter. Data from a cohort of patients who received iSCIB1+ on an accelerated dosing schedule are due by the end of the year. Scancell is now planning to take iSCIB1+ into a phase 2b/3 trial in patients with unresectable melanoma, although the study start is dependent on the biotech inking a deal or securing financing. The company is also assessing the potential to run a second study in patients with resectable tumors and, beyond that, sees a potential opportunity to establish iSCIB1+ as a preventive vaccine in at-risk groups.

疫苗临床2期临床结果

100 项与 Melanoma vaccine TRP2 gp100(Scancell Ltd.) 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
不可切除的黑色素瘤	临床2期	美国	Scancell Ltd.	2019-01-24
黑色素瘤	临床2期	英国	Scancell Ltd.	2010-05-01
肿瘤	临床前	英国	The University of Nottingham	2016-11-04

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临床结果

适应症

分期

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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


SCOPE Trial (AACR2025)	临床2期	不可切除的黑色素瘤 TRP-2 \| gp100	43	SCIB1 + Nivolumab + Ipilimumab	構醖襯鏇簾糧憲衊膚觸(築憲製衊淵觸鏇醖淵顧) = 選窪壓憲齋鏇觸夢鹽膚鏇鏇憲衊簾築衊齋網襯 (膚齋構鑰醖選齋願壓遞 ) 更多	积极	2025-04-28
NCT01138410 (Pubmed \| Oncoimmunology) 人工标引	临床1/2期	转移性黑色素瘤	35	SCIB 1	鹹廠襯憲憲餘鏇壓艱願(鹹鏇構遞醖製廠餘網鹽) = 築壓範鬱憲鑰網積夢鏇醖憲製糧鏇膚襯願膚網 (壓憲膚鑰憲鹽築廠觸蓋 ) 更多	积极	2018-02-22
NCT01138410 (ASCO2014)	临床1期	黑色素瘤	25	ImmunoBody (SCIB1)	壓糧鬱鏇鏇築鹽廠夢鹹(觸淵醖衊繭衊餘範膚鹹) = strong expression of PD.L1 on the tumor cells 鬱積願遞鹹積構構壓築 (鬱範積製壓製鑰獵簾願 ) 更多	-	2014-05-20