A Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in Patients With Advanced Unresectable Melanoma Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

The purpose of this study is to find out if two new treatment cancer vaccines called SCIB1 and iSCIB1+ can be used safely when added to nivolumab (Opdivo) with ipilimumab (Yervoy), or SCIB1 with pembrolizumab (Keytruda). Pembrolizumab or nivolumab with ipilimumab are standard treatments approved for patients with advanced melanoma (skin cancer).
The study will also look to see if SCIB1 or iSCIB1+ can increase the likelihood that melanoma patients will respond to the standard treatments, and also if SCIB1 and iSCIB1+ can help to make those responses last longer. SCIB1 and iSCIB1+ are considered experimental. SCIB1 has been given to melanoma patients in an earlier study. It was generally well-tolerated, and researchers saw some signs that it may help to stimulate the immune system, which is a way in which the body can fight the cancer. iSCIB1+ is similar to SCIB1 but might benefit more patients with melanoma.

开始日期2019-08-19

申办/合作机构

Scancell Ltd.

100 项与 iSCIB1+ (Scancell) 相关的临床结果

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100 项与 iSCIB1+ (Scancell) 相关的转化医学

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100 项与 iSCIB1+ (Scancell) 相关的专利（医药）

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项与 iSCIB1+ (Scancell) 相关的新闻（医药）

2026-05-01

·allsci.com

Scancell Holdings’ iSCIB1+ DNA immunotherapy gains FDA Fast Track for advanced melanoma

Scancell Holdings plc (LSE: SCLP), a clinical-stage biotechnology company headquartered in Oxford, United Kingdom, announced receipt of US FDA Fast Track Designation for iSCIB1+, a DNA-based active immunotherapy developed on its ImmunoBody platform, for the treatment of advanced melanoma. The designation was accompanied by an updated data release from the Phase II SCOPE trial, which reported a 77% progression-free survival (PFS) rate at 20 months in an HLA-matched target population receiving iSCIB1+ in combination with ipilimumab and nivolumab. Fast Track Designation enables more frequent FDA interactions during development, rolling review eligibility, and potential access to Priority Review and Accelerated Approval pathways. No prior expedited designation has been reported for iSCIB1+. The SCOPE study (NCT04079166) is a Phase II, multicentre, open-label trial enrolling patients with advanced unresectable melanoma across 16 UK clinical sites. The trial evaluates SCIB1 or iSCIB1+ added to standard-of-care checkpoint regimens, including nivolumab plus ipilimumab and pembrolizumab. The target population is defined by the presence of specific human leukocyte antigen (HLA) alleles, estimated to be present in approximately 80% of melanoma patients, and represents the population Scancell intends to select for its planned Phase III trial. The 77% PFS figure at 20 months in the HLA-matched cohort compares to a 43% PFS rate at 20 months reported for ipilimumab plus nivolumab alone in the pivotal CheckMate 067 trial, a difference of more than 30 percentage points on a descriptive basis. Across evaluable patients in Cohorts 1 and 3 combined, the objective response rate (ORR) was 68.6% (46 of 67 patients), the disease control rate (DCR) was 88.0%, and the complete response rate was 17.9% (12 of 67 patients). Cohort 3 alone, the HLA-matched group, reported an ORR of 64.5% and a DCR of 80.6%. These figures were drawn from the April 28, 2026 data package; no formal p-values were reported, consistent with the non-comparative, single-arm Phase II design. The PFS trajectory has shown consistent maturation across earlier readouts, moving from 80.8% at 11 months to 74% at 16 months, as reported in a December 2025 update, to the current 77% at 20 months. Additional PFS data and early overall survival (OS) data from SCOPE are expected in H1 2027. Scancell received FDA Investigational New Drug (IND) clearance for a global Phase III trial of iSCIB1+ in advanced melanoma in January 2026, with initiation of that registrational study anticipated in H2 2026. HLA-matched status is expected to serve as the patient-selection biomarker in the Phase III design. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

临床2期临床结果快速通道临床3期免疫疗法

2026-04-28

·PharmaIntel

PharmaIntel ｜每日监控｜2026 年 4 月 27 日

PharmaIntel每日生物医药情报简报 · 过去24小时关键事件7新事件2监管批准2融资事件2临床进展1并购交易监管批准AstraZenecaSaphnelo (anifrolumab)2026-04-27监管批准 FDA 批准 Saphnelo 皮下注射剂型的自我给药适应症，成为全球首个获批自我给药的 I 型干扰素受体抗体。适用于系统性红斑狼疮（SLE）成人患者，患者可在家自行注射，无需前往医疗机构。此前 Saphnelo 静脉制剂已于 2021 年获批，皮下剂型将显著提升用药便利性。FDA 皮下注射 SLE 自我给药GSK / IonisBepirovirsen2026-04-28监管批准 FDA 接受 Bepirovirsen 新药申请（NDA）并授予优先审评资格（Priority Review）。Bepirovirsen 是首个针对慢性乙型肝炎（CHB）的功能性治愈方案，为反义寡核苷酸（ASO）药物，旨在抑制乙肝病毒 RNA 产生。Phase 3 B-Well 试验显示，联合标准治疗可显著提高功能性治愈率。PDUFA 日期尚未公布。FDA 优先审评乙肝功能性治愈 ASO融资事件Coultreon BiopharmaCOL-5671 (SIK3 抑制剂)2026-04-28融资完成 $125M Series A 融资，由 Sofinnova Investments 领投，Forbion、Novo Holdings、Galapagos 及 Regeneron 风投部门参投。公司从 Galapagos 授权获得口服 SIK3 抑制剂 COL-5671，目前处于 Phase 1，计划年内启动银屑病和溃疡性结肠炎的 Phase 2 试验。公司前身为 Onco3R Therapeutics，专注于自身免疫疾病口服药物。$125M Series A SIK3 自身免疫比利时Paradigm BiopharmaceuticalsPentosan Polysulfate Sodium (PPS)2026-04-27融资通过增发融资 $14M（约 2200 万澳元），用于推进骨关节炎治疗药物 PPS 的 Phase 3 试验。公司已计划向 FDA 提交关键中期数据，目标是在完成试验后申请上市许可。PPS 是一种已批准用于治疗间质性膀胱炎的药物，Paradigm 正在开发其骨关节炎新适应症。$14M 骨关节炎 Phase 3 澳大利亚临床进展Intellia TherapeuticsLonvoguran ziclumeran (lonvo-z)2026-04-27临床进展公布全球首个体内 CRISPR 基因编辑疗法的 Phase 3 HAELO 试验数据。Lonvo-z 用于治疗遗传性血管性水肿（HAE），数据显示在单次给药后可显著降低 HAE 发作频率，安全性和耐受性良好。这是 CRISPR 技术从实验室走向商业化批准的关键里程碑，Intellia 计划年内提交监管申请。Phase 3 CRISPR 基因编辑 HAE 里程碑ScancelliSCIB1+2026-04-28临床进展 FDA 授予 iSCIB1+ 快速通道资格（Fast Track Designation），用于治疗晚期黑色素瘤。iSCIB1+ 是 Scancell 的 ImmunoBody DNA 癌症疫苗平台产物，旨在激活患者自身免疫系统攻击肿瘤细胞。快速通道资格将加速其临床开发和审评进程，预计将在转移性黑色素瘤患者中开展关键试验。FDA 快速通道黑色素瘤 DNA 疫苗并购交易Ligand Pharmaceuticals收购 XOMA Royalty2026-04-27并购宣布以 $739M（每股 $39 现金）收购 XOMA Royalty，溢价约 14%。交易将 Ligand 的特许权组合扩展至超过 200 项资产，新增 7 个商业化产品，Phase 2/3 资产近翻倍。亮点包括 Roche 的 VABYSMO、Day One 的 OJEMDA 等。预计 2026 年 Q3 完成，当年即可增厚每股收益。Ligand 上调 2026 年调整后 EPS 指引至 $8.50-$9.50。$739M 特许权聚合即时增值 2026Q3 交割PharmaIntel v2.4 · 数据源：FDA、企业公告、行业媒体 · 生成时间：2026-04-28 21:40 CST本简报仅供行业参考，不构成投资建议

2026-04-28

·BioSpace

Scancell receives FDA Fast Track Designation for iSCIB1+ in advanced melanoma and provides data update from its SCOPE Phase 2 study

Potent and durable efficacy with iSCIB1+ of 77% progression free survival (PFS) at 20 months, in combination with ipilimumab and nivolumab, demonstrated in the Phase 2 SCOPE trial; more PFS and additional early overall survival (OS) data expected in H1 2027 Initiation of the registrational Phase 3 trial with iSCIB1+ in advanced melanoma anticipated in H2 2026 OXFORD, United Kingdom, April 28, 2026 (GLOBE NEWSWIRE) -- Scancell Holdings plc (AIM: SCLP) , the developer of active immunotherapies to treat cancer, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead ImmunoBody ® iSCIB1+ for the treatment of advanced melanoma. Dr Phil L'Huillier, CEO of Scancell , said: "This designation is a major achievement for Scancell and important recognition not only of the potential of iSCIB1+, but also of the significant need for new and improved treatment options for patients with advanced melanoma. We are very pleased with how the Phase 2 SCOPE data is maturing and are advancing plans for a global registrational Phase 3 trial, which we expect to initiate in the second half of 2026." Progression free survival (PFS) has matured positively, reaching 77% at 20 months in the target population 1 . This widens the lead of iSCIB1+ over PFS reported with ipilimumab plus nivolumab alone of 43% at 20 months, now representing a 30+ percentage point improvement over standard of care (SoC). 2 The Fast Track Designation is granted for investigational therapies that show advantage over available treatments, such as superior effectiveness, and provides the process to expedite review of drugs for serious conditions, with the aim of getting effective therapies to patients faster. The designation enables frequent engagement to ensure alignment on development plans, enhance development predictability and support a more efficient path through clinical development. Moreover, Fast Track Designation brings eligibility for Accelerated Approval, Priority Review and Rolling Review. Additional PFS data and early OS data from the Phase 2 SCOPE study are expected in H1 2027. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). About the SCOPE Phase 2 study The SCOPE study (NCT04079166) is a Phase 2, Multicentre, Open-Label, Study in Advanced Unresectable Melanoma. Patients receiving either Nivolumab plus Ipilimumab or Pembrolizumab as standard of care (SoC) will also be treated with SCIB1 or iSCB1+. The study aims to determine the efficacy and safety of SCIB1 or iSCIB1+ when added to these SoC therapies. Additional endpoints include disease control rate (DCR), duration of response (DOR), progression free survival (PFS), overall survival (OS). Participants receive up to 11 doses of either SCIB1 or iSCIB1+ using the PharmaJet needle-free injection devices. More information at clinicaltrials.gov. Scancell (LSE:SCLP; ) is a clinical stage biotechnology company developing targeted off-the-shelf active immunotherapies, to generate safe and long-lasting tumour-specific immunity for a cancer-free future. iSCIB1+, the lead product from their DNA ImmunoBody ® platform has demonstrated safe, durable and clinically meaningful benefit as a monotherapy as well as additional benefit when combined with checkpoint therapies in a Phase 2 trial in melanoma. Modi-1, the lead peptide immunotherapy from their Moditope ® platform, is being investigated in a Phase 2 study in a broad range of solid tumours. In addition, Scancell's wholly owned subsidiary, GlyMab Therapeutics Ltd., has been established with the intention to hold and develop an exciting early-stage pipeline of high affinity GlyMab ® antibodies targeting tumour specific glycans, two of which already have been licensed and are being developed by Genmab A/S, an international biotechnology company and global leader in the antibody therapeutics space. For more information please contact: Scancell Holdings plc +44 (0) 20 3709 5700 Phil L'Huillier, CEO Panmure Liberum (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Emma Earl, Will Goode, Mark Rogers (Corporate Finance) Rupert Dearden (Corporate Broking) WG Partners LLP (Joint Broker) David Wilson, Claes Spang +44 (0) 20 3705 9330 Investor and media relations Mary-Ann Chang +44 (0) 20 7483 284853 MaryAnnChang@scancell.co.uk __________________ 1 The target population represents patients with human leukocyte antigen (HLA) alleles present in approximately 80% of melanoma patients in the SCOPE trial's third cohort, which also represents the population to be selected in the Company's upcoming Phase 3 trial. 2 SoC represents the combination of ipilimumab and nivolumab measured using the results of the pivotal Checkmate 067 trial This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit .

临床2期免疫疗法快速通道临床3期临床结果

100 项与 iSCIB1+ (Scancell) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
皮肤黑色素瘤	临床2期	英国	Scancell Ltd.	2019-08-19
不可切除的黑色素瘤	临床2期	英国	Scancell Ltd.	2019-08-19
黑色素瘤	临床2期	-	Scancell Ltd.	-

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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


AACR2026	临床2期	黑色素瘤一线	80	SCIB1+nivolumab+ipilimumab	簾壓築襯網襯廠積繭繭(鬱選網鑰網壓築壓顧簾) = 積製鹹襯窪鬱淵鬱積夢積鹽獵衊鹹觸齋憲繭膚 (夢選餘鹽糧壓鹽夢網鬱 ) 更多	积极	2026-04-21
SCOPE (NEWS) 人工标引	临床2期	黑色素瘤	67	SCIB1 with standard checkpoint inhibitors or iSCIB1+ with standard checkpoint inhibitors	糧鏇窪淵襯鬱衊網齋鏇(餘蓋獵糧壓餘鏇襯廠膚) = 願觸衊顧構膚遞醖構憲膚網網獵餘艱選鹹網窪 (構範淵襯蓋鏇築廠鹹繭 ) 更多	积极	2025-07-22
				SCIB1+standard checkpoint inhibitors	築鑰選淵鏇廠鏇醖憲積(築觸鹹繭憲構衊構鏇築) = 獵齋廠衊範遞願範顧廠鬱壓鏇範構選艱獵鑰願 (膚膚觸願糧襯繭遞繭窪 )
NCT04079166 (SCOPE, GlobeNewswire)	临床2期	黑色素瘤一线 HLA-A*02 positive	140	SCIB1+iSCIB1iSCIB1++ipilimumab+Nivolumab	壓窪膚壓遞築鑰願夢遞(襯憲願願繭醖憲餘衊鑰) = 憲窪觸鏇醖憲選壓構鹽衊顧繭積構壓襯獵蓋選 (鹽鬱構齋觸選鬱構蓋糧 ) 更多	积极	2025-07-22
				SCIB1+ipilimumab+Nivolumab	遞餘廠繭淵糧壓顧衊選(蓋選襯鬱衊衊鑰襯襯鬱) = 鹽膚選選衊製衊淵顧築憲遞鹽齋艱獵遞構衊醖 (築顧鬱憲遞製簾醖網遞 )