A Phase 1, Multicentre, Open-label, Nonrandomised, First-in-human Study of OVM-200 as a Therapeutic Vaccine in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer, Ovarian Cancer, and Prostate Cancer

OVM-200 will be tested in humans for the first time in Study OVM-200-100. Up to 52 patients aged 18-75 with prostate, lung or ovarian cancer will be enrolled in the Study to find out if OVM-200 is safe to continue studying it in patients with cancer. The Study consists of 2 parts: a dose escalation part and a dose expansion part. In the dose escalation part, up to 4 increasing doses of OVM-200 will be evaluated in small groups of cancer patients to find the recommended dose for the expansion part. The recommended dose of OVM-200 will then be given to cancer patients in the dose expansion part to confirm safety and understand how effective it is against their disease and if there are any side effects.
Patients who agree to participate in the Study and pass screening will receive 3 doses of OVM-200 in total at 2-week intervals as an injection under the skin. After completing treatment with OVM-200 patients will be followed up for side effects and to monitor changes in their cancer. Patients will stay on the Study for about 6 months in total during which they will have 10 hospital visits. The Study will run at around 5 sites in the UK.

开始日期2021-11-01

申办/合作机构

Oxford Vacmedix UK Ltd.

100 项与 OVM-200 相关的临床结果

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100 项与 OVM-200 相关的转化医学

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100 项与 OVM-200 相关的专利（医药）

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项与 OVM-200 相关的文献（医药）

2026-01-01·EClinicalMedicine

Survivin recombinant overlapping peptide (ROP) vaccine in advanced solid tumours: a first-in-human, multicentre, open-label, phase 1a dose-escalation study

Article

作者: Flynn, Michael ; Jiang, Shisong ; Tuthill, Mark ; Thistlethwaite, Fiona ; Wijaya, Wynne ; Lu, Wenshu ; Finch, William ; Morris, Thomas ; Forster, Martin D ; Williams, Anja

Background:

Survivin, an inhibitor of apoptosis protein (IAP), is highly expressed in various cancers but has weak immunogenicity as a self-derived tumour-associated antigen (TAA). OVM-200, a survivin recombinant overlapping peptide (ROP) vaccine, consists of overlapping peptides linked by the target sequence (LRMK) for cathepsin S, preserving T-cell and most antibody epitopes. OVM-200 elicits both cellular and humoral immune responses against survivin-expressing cancer cells. This phase 1a, multicentre, open-label trial (OVM-200-100) evaluates OVM-200 as a therapeutic vaccine in patients with non-small cell lung, ovarian, and prostate cancer. This Phase 1 trial is also the first time the ROP technology platform has been used in human trials.

Methods:

Twelve eligible patients received three subcutaneous OVM-200 doses at 2-week intervals using a 3 + 3 dose-escalation design. Four dose levels (250, 500, 1000, and 2000 μg) were tested to determine the optimal dose for phase 1b. The primary endpoint was safety and tolerability, while secondary endpoints included immunogenicity (antibody and T-cell response) and tumour response (RECIST criteria). This trial was registered with ClinicalTrials.gov (NCT05104515) and EudraCT (2021-001545-12) and took place from 28/09/2021 to 04/05/2023.

Findings:

OVM-200 was well tolerated, with no serious adverse drug reactions (ADRs) or dose-limiting toxicities (DLTs). All adverse events were Grade 1 injection site reactions (ISRs). The 2000 μg dose group achieved the highest median anti-survivin IgG titre (1:327,680) at the end of the study (EOS) and a median ELISpot T cell response of 1282 SFU per million cells on day 22. Disease stabilisation (SD) was observed in 6 of 12 patients (50%), including all 3 patients (100%) in the 2000 μg group, some of which were stabilisations of limited duration. Based on these findings, the 2000 μg dose was selected for further evaluation in phase 1b.

Interpretation:

OVM-200 is well tolerated and induces a robust humoral response, with a considerable cellular response and preliminary evidence of disease stabilisation. Phase 1b is ongoing to further evaluate its safety and efficacy at the selected dose.

Funding:

Oxford Vacmedix UK Ltd.

项与 OVM-200 相关的新闻（医药）

2026-01-06

·医学新视点

激活双重免疫抗癌！新型肿瘤疫苗初步临床证据积极，或用于治疗肺癌、卵巢癌、前列腺癌等

肿瘤疫苗可分为预防性疫苗和治疗性疫苗，其中肿瘤治疗性疫苗的原理是将肿瘤抗原以多种形式，如肿瘤细胞、多肽、表达肿瘤抗原的基因等，注射入患者体内，增强免疫原性，激活人体自身特异性免疫反应，从而达到控制或清除肿瘤的目的。 Survivin蛋白是凋亡抑制蛋白（IAPs）家族中的一员，在大多数肿瘤及胚胎组织中广泛表达但在终末分化的正常成人组织中则检测不到，与肿瘤进展和预后不佳有关。OVM-200是一种基于survivin蛋白的重组重叠肽（ROP）疫苗，既往动物实验发现，survivin ROP疫苗能够有效刺激CD4和CD8细胞免疫应答。近日，OVM-200人体临床试验结果发表于《柳叶刀》子刊eClinicalMedicine，表明OVM-200展现出良好的耐受性，并能诱导体液免疫应答，同时伴随有细胞免疫反应，以及展现出可使疾病稳定的初步证据。目前，OVM-200正在开展1b期临床试验，以进一步验证其疗效。截图来源：eClinicalMedicine 这项多中心、开放标签、非随机研究，共纳入12例局部晚期无法手术或转移性非小细胞肺癌、卵巢癌或前列腺癌患者。所有患者均已用尽标准治疗方案或处于无治疗间歇期。研究人员将患者分配接受250 μg、500 μg、1000 μg和2000 μg四种剂量的OVM-200，每位患者接受3次皮下注射OVM-200，间隔两周。 ▲研究时间线（图片来源：参考文献[1]）主要终点是安全性和耐受性。结果显示，所有患者均经历了1级注射部位反应，如注射部位疼痛、肿胀或瘙痒等，未观察到与OVM-200相关的严重不良事件发生。次要终点包括免疫原性和肿瘤反应。其中，OVM-200 2000 μg剂量组显示出最佳的体液免疫反应，其抗survivin抗体滴度随时间持续升高，并维持至研究结束。研究结束时（第169天），OVM-200 2000 μg剂量组达到最高中位抗survivin IgG滴度值（1：327680）。细胞免疫应答方面，第22天时，OVM-200 2000 μg剂量组实现1282 SFU/106cells 的中位ELISpot T细胞反应。疾病进展与肿瘤治疗效果方面，12例患者中观察到疾病稳定（SD）者6例（50%），其中OVM-200 2000 μg剂量组的3例患者全部达到疾病稳定（100%），部分患者呈现短期稳定状态。此外，疾病稳定患者的T细胞反应显著强于疾病进展者（中位819 SFU/106 cells vs. 83 SFU/106 cells，P=0.0303）。基于上述发现，OVM-200 2000 μg剂量被选定用于后续1b期临床试验的评估。文章表示，鉴于OVM-200所表现出的安全性和免疫原性特征，其或可被纳入多模式免疫治疗策略，通过与免疫检查点抑制剂、细胞疗法等治疗方式联用，达到更好的治疗作用。点击文末“阅读原文/Read more”，即可访问期刊官网阅读完整论文。推荐阅读《自然》重磅：三年生存率接近翻倍！治疗癌症的疫苗已经出现了？《自然-医学》：部分患者产生高水平反应！全新癌症疫苗有望延长患者生命题图来源：123RF 参考资料 [1] Wijaya, Wynne et al. Survivin recombinant overlapping peptide (ROP) vaccine in advanced solid tumours: a first-in-human, multicentre, open-label, phase 1a dose-escalation study. eClinicalMedicine, Volume 91, 103717 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「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com 分享，点赞，在看，传递医学新知

临床结果疫苗免疫疗法临床2期

2025-11-17

·重组重叠肽结核诊断免疫治疗产品

牛津疫苗医学有限公司宣布OVM-200一期临床试验完成最后一名受试者给药

所有受试者已完成OVM-200一期临床试验的治疗阶段英国牛津 – 2025年11月17日牛津疫苗医学有限公司（Oxford Vacmedix, OVM）今日宣布，其主要抗癌疫苗OVM-200 的一期临床试验已完成“最后一名受试者给药”这一重要里程碑。该试验的第二阶段（1b期）在英国四家领先医院开展，患者接受了最长达六个月的OVM-200治疗。该延长给药方案由临床研究者提出，基于一期a阶段中优异的安全性结果。OVM-200 是一种基于 OVM 自主研发的重组重叠肽（ROP）平台开发的新型免疫治疗疫苗，靶向癌细胞高表达的蛋白 survivin（存活素），该蛋白可防止癌细胞被免疫系统识别和清除。本次试验不仅是 OVM-200 首次用于人体研究，也是全球首个进入临床阶段的基于 ROP 技术的疫苗。该研究的主要目标是评估OVM-200的初步安全性及其在三种肿瘤类型中的免疫应答情况：非小细胞肺癌（NSCLC）、前列腺癌和卵巢癌。共有36名患者参与了此次临床试验，其中一位最新入组的NSCLC患者表现尤为突出，在六个月内接受了最多允许的11次免疫接种且未出现疾病进展。试验数据库将在未来四周内封锁以完成数据录入。一期a阶段已显示出极佳的安全性和强烈的免疫反应，而一期b阶段预计将进一步确认并强化这些结果。牛津疫苗医学公司首席执行官William Finch 表示： “我们非常高兴能达到这一关键里程碑，这离不开各试验中心医生和护士的辛勤付出，当然也要感谢所有参与的患者。我们预计将在不久后获得最终临床报告，目前我们已看到疫苗在安全性、免疫原性方面的良好表现，更令人鼓舞的是出现了一些初步的临床疗效迹象。” 首席医疗官 Dr Tom Morris 补充道： “ROP技术从最初的实验室概念出发，现已应用于晚期癌症患者的治疗，这些患者几乎没有其他治疗选择。该疫苗不仅能激活机体免疫系统攻击肿瘤，还有望增强其他免疫肿瘤治疗药物的疗效。完成此次I期试验是我们向有效癌症疫苗迈出的关键第一步。”媒体及投资联系 William Finch, 首席执行官 T: +44 (0)1865 742087 | M: +44 (0)7769 903711 | E: wfinch@oxfordvacmedix.com Dr Nam Park, 首席商务官 T: +44 (0)1865 742087 | M: +44 (0)7904 613938 | E: npark@oxfordvacmedix.com编辑说明关于牛津疫苗医学有限公司（Oxford Vacmedix, OVM）：牛津疫苗医学有限公司总部位于英国牛津科学园，是一家由牛津大学肿瘤学系分拆成立的生物制药公司，利用由姜石松教授发明的重组重叠肽（ROP）技术平台开发创新型治疗性疫苗与诊断产品。ROP技术能够有效诱导广泛且强烈的T细胞免疫反应，是开发癌症与传染病疫苗及诊断产品的理想平台。该平台具有更高效价、更低成本、更简化监管流程的潜在优势，并在与其他免疫肿瘤药物（IO药物）联合使用时表现出协同效应。公司通过与中国的牛津石松生物集团（CBIG）合作，将ROP技术应用于癌症和传染病诊断产品的开发。 OVM目前有两款核心疫苗产品：- OVM-100：靶向HPV相关的头颈癌与宫颈癌；- OVM-200：靶向survivin的实体瘤治疗性疫苗。两款疫苗均计划作为单药及联合免疫肿瘤药物使用。近期，OVM获得韩国上市制药公司 Dx&Vx 的B轮领投及中国现有股东的追加投资，资金将用于推进 OVM-200进入二期临床试验及 OVM-100进入一期临床试验。更多信息请访问: www.oxfordvacmedix.com Last patient out milestone reached in Phase 1 trial of OVM-200 All patients have completed treatment in the Phase 1 trial of Oxford Vacmedix’s lead cancer vaccine OVM-200 Oxford, UK – 17 November 2025 Oxford Vacmedix (OVM) announced today the last patient out milestone in the Phase 1 trial of lead cancer vaccine OVM-200. Phase 1b, the second part of the trial, has involved patients being treated with up to six months therapy of OVM-200, at four leading hospitals in the UK. The extended dosing protocol was first suggested by the clinical investigators in the trial following the excellent safety record in Phase 1a. OVM-200 is a novel form of immunotherapy developed using OVM’s recombinant overlapping peptide (ROP) platform. It targets survivin, a protein overexpressed by cancer cells, which prevents them being attacked by the body’s immune system. This trial is both the first time OVM-200 has been used in people and also the first time any ROP based vaccine has been tested in the clinic. The trial has focused on establishing the initial safety profile and examining the immune response in patients with three tumour types – non small cell lung cancer (NSCLC), prostate cancer and ovarian cancer. 36 patients have participated in this Phase 1 trial with the most recent NSCLC patient doing particularly well and receiving the maximum allowed 11 immunisations over six months without disease progression. The database for the trial will be locked over the next four weeks when all patient data has been logged. The first part of the trial, Phase 1a, showed both excellent safety and a strong immune response. Phase 1b is anticipated to confirm and enhance these results for the vaccine. William Finch, CEO of Oxford Vacmedix, said: “We are delighted to reach this important milestone, which would not have been possible without the doctors and nurses at the trial centres and of course the patients who have participated. We expect to have the final clinical trial report very soon and are very pleased to be seeing safety, immunogenicity and, most excitingly, some initial signs of clinical activity. Dr Tom Morris, Chief Medical Officer of Oxford Vacmedix added: “This ROP technology has been developed from an initial concept in the laboratory and has now been tested as a treatment for patients with advanced cancers that have exhausted all other therapies. The vaccination approach both stimulates the body’s immune system to attack the cancer and has the potential to enhance the efficacy of other immune oncology agents. Completing this Phase I trial is a critical first step towards having effective cancer vaccines.” For more information or to inquire about investing in Series B please contact: William Finch, CEO, Oxford Vacmedix T: +44 (0)1865 742087 | M: +44(0)7769 903711 | E:wfinch@oxfordvacmedix.com Dr Nam Park, Chief Business Officer, Oxford Vacmedix T: +44 (0)1865 742087 | M: +44(0)7904 613938 | E:npark@oxfordvacmedix.com Notes to Editor About Oxford Vacmedix Oxford Vacmedix UK Ltd, based at the Oxford Science Park, UK, is a bio-pharma company that was spun out from the University of Oxford’s Department of Oncology and is utilising the novel proprietary platform technology of recombinant overlapping peptides (ROPs) invented by Professor Shisong Jiang. ROPs have been validated as a technology to stimulate broad and strong T cell immunity therefore forming a good platform for therapeutic vaccines and diagnostics in cancer and infectious diseases. The technology uses the novel, proprietary platform of ROPs to design and develop therapeutic cancer vaccines and diagnostics with the potential for increased efficacy, lower costs, simpler regulatory pathways and synergy when used in combination with other immune oncology (IO) agents. The company has extensive contacts and collaborations in China through Changzhou Bioscience Group (CBIG) that is using the ROP platform for diagnostics in both cancer and in infectious diseases. OVM is developing two lead vaccines, OVM-100 and OVM-200, focusing on unmet clinical need. OVM-100 is an HPV vaccine targeted at head and neck and cervical cancer, and OVM-200 represents a new type of immunotherapy utilising survivin to target solid tumours. Both vaccines will be tested as single agents and in combination with IO agents. OVM has recently secured the lead investment in Series B from Dx&Vx, a leading South Korean Pharma company, listed on KOSDAQ, and from existing shareholders in China. The company is currently seeking further Series B funding to advance OVM-200 to Phase 2 and OVM-100 into Phase 1 trials, as monotherapy and also in combination. For more information: http://www.oxfordvacmedix.com

临床1期疫苗临床结果免疫疗法

2025-08-03

·药时空

Nature子刊综述：细菌mRNA疫苗设计中的主要挑战、应对与临床现状

近日，总部位于韩国的Dx&Vx（DXVX）签署了其成立以来的首份全球对外授权协议。DXVX与一家美国生物科技公司就其基于mRNA的癌症疫苗达成了一项价值约2.2亿美元的联合开发和授权协议。商业化后的收益分成将另行处理。通过该协议，DXVX 将授予其合作伙伴其基于 mRNA 的专利肿瘤疫苗的全球独家权利。合作伙伴公司将向 DXVX 支付总计约2.2 亿美元的开发里程碑费用，并在商业化后，在超过 15 年的时间内，支付超过累计销售额 10% 的基于销售的里程碑费用。鉴于全球肿瘤疫苗市场的巨大规模和增长潜力以及预期的市场份额，DXVX 预计商业化后的销售里程碑收入可能超过 9.4 亿美元。即使在授权完成后，DXVX 仍将负责领导商业化所需的研发活动，包括临床前研究、1-3 期临床试验和生产。合作公司将负责全球监管审批和销售。其他具体条款经双方协商后保密。本次许可协议涵盖的基于mRNA的肿瘤疫苗是DXVX专有研发管线的一部分，其在临床前动物研究中已证明其抗癌效果优于目前正在进行 2b期临床试验的全球竞争对手。DXVX已完成该化合物的专利申请。此外，该候选疫苗采用了DXVX专有的长期常温储存mRNA疫苗平台技术，确保了其在技术上优于竞争对手的优势。目前，具体合作对象尚未披露。DXVX首席执行官Kevin Kwon“我们非常高兴签署首份全球对外授权协议。我们衷心感谢合作伙伴对我们技术实力的认可。我们相信，这份协议将对目前正在进行的其他管道授权谈判产生积极影响。”关于Dx&Vx Dx&Vx是一家以多组学与人工智能驱动、总部位于韩国首尔的生物技术公司，聚焦个性化 mRNA 及其他生物治疗产品的设计与开发。Dx&Vx 构建了一个基于人工智能的 mRNA 结构与序列优化平台，旨在开发下一代可定制的 mRNA 疫苗和治疗性 mRNA 分子。该平台从 5′ UTR、CDS 到结构元件综合建模，通过深度学习改造增强型 mRNA 结构单元，以提高翻译效率与稳定性，已进入早期设计和构建阶段。其研发管线不仅包括用于肿瘤的 mRNA 疫苗，还拓展到具有常温长效存储能力的疫苗平台、口服抗肥胖治疗以及肽类癌症疫苗（如 OVM-200）等多条并行开发路径。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

疫苗信使RNA引进/卖出临床1期临床2期

100 项与 OVM-200 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
局部晚期非小细胞肺癌	临床1期	英国	Oxford Vacmedix UK Ltd.	2021-11-01
转移性非小细胞肺癌	临床1期	英国	Oxford Vacmedix UK Ltd.	2021-11-01
卵巢癌	临床1期	英国	Oxford Vacmedix UK Ltd.	2021-11-01
前列腺癌	临床1期	英国	Oxford Vacmedix UK Ltd.	2021-11-01
肿瘤	临床1期	韩国	Dx & Vx Co., Ltd.	-