Activity and Safety of Peptide-based Immunotherapy in an Umbrella Window-of-opportunity Phase II Study in Patients With Squamous Cell Carcinoma of the Head and Neck.

The purpose of this project is to realize a randomized open-label study (EudraCT number: 2020-000120-19) to evaluate the safety and the anti-tumor activity of peptide(s)-based immunotherapy in an umbrella window pre-operative opportunity phase II study in patients with squamous cell carcinoma of the head and neck.

开始日期2020-08-14

申办/合作机构

Cliniques Universitaires Saint-Luc

NCT03850522

/ Terminated临床2期IIT

Phase IIa Trial of PD-L1 Peptide Vaccination as Monotherapy in High Risk Smoldering Multiple Myeloma

This study is evaluating a new vaccine against PD-L1 as a possible treatment for high-risk smoldering multiple myeloma.

开始日期2019-02-18

申办/合作机构

Herlev Hospital

[+1]

NCT03714529

/ Completed临床2期IIT

Phase IIa Trial With PD-L1 IO103 Vaccination With Montanide in Patients With Basal Cell Carcinoma

A single center, open-label, phase IIa, single arm, window of opportunity trial with IO103 and Montanide adjuvant in patients with surgically resectable BCC.

开始日期2018-11-01

申办/合作机构

Herlev Hospital

[+1]

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100 项与 etimumotide 相关的专利（医药）

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项与 etimumotide 相关的文献（医药）

2023-10-01·Bioactive materials

All-in-one glycol chitosan nanoparticles for co-delivery of doxorubicin and anti-PD-L1 peptide in cancer immunotherapy

Article

作者: Yun, Wan Su ; Yoon, Hong Yeol ; Song, Sukyung ; Kim, Kwangmeyung ; Cho, Hanhee ; Yang, Suah ; Han, Eun Hee ; Lee, Jaewan ; Moon, Yujeong ; Shim, Man Kyu ; Min, Jin Young

Synergistic immunotherapy of immune checkpoint blockade (ICB) and immunogenic cell death (ICD) has shown remarkable therapeutic efficacy in various cancers. However, patients show low response rates and undesirable outcomes to these combination therapies owing to the recycling mechanism of programmed death-ligand 1 (PD-L1) and the systemic toxicity of ICD-inducing chemotherapeutic drugs. Herein, we propose all-in-one glycol chitosan nanoparticles (CNPs) that can deliver anti-PD-L1 peptide (PP) and doxorubicin (DOX) to targeted tumor tissues for a safe and more effective synergistic immunotherapy. The PP-CNPs, which are prepared by conjugating ᴅ-form PP (NYSKPTDRQYHF) to CNPs, form stable nanoparticles that promote multivalent binding with PD-L1 proteins on the targeted tumor cell surface, resulting in effective lysosomal PD-L1 degradation in contrast with anti-PD-L1 antibody, which induces recycling of endocytosed PD-L1. Consequently, PP-CNPs prevent subcellular PD-L1 recycling and eventually destruct immune escape mechanism in CT26 colon tumor-bearing mice. Moreover, the ICD inducer, DOX is loaded into PP-CNPs (DOX-PP-CNPs) for synergistic ICD and ICB therapy, inducing a large number of damage-associated molecular patterns (DAMPs) in targeted tumor tissues with minimal toxicity in normal tissues. When the DOX-PP-CNPs are intravenously injected into CT26 colon tumor-bearing mice, PP and DOX are efficiently delivered to the tumor tissues via nanoparticle-derived passive and active targeting, which eventually induce both lysosomal PD-L1 degradation and substantial ICD, resulting in a high rate of complete tumor regression (CR: 60%) by a strong antitumor immune response. Collectively, this study demonstrates the superior efficacy of synergistic immunotherapy using all-in-one nanoparticles to deliver PP and DOX to targeted tumor tissues.

2023-05-01·Journal for immunotherapy of cancer

Long-term follow-up of anti-PD-1 naïve patients with metastatic melanoma treated with IDO/PD-L1 targeting peptide vaccine and nivolumab

Article

作者: Marie Svane, Inge ; Lorentzen, Cathrine Lund ; Andersen, Mads Hald ; Kjeldsen, Julie Westerlin ; Ehrnrooth, Eva

Background:

We have previously published initial efficacy of the indoleamine 2,3-dioxygenase (IDO)/anti-programmed death ligand 1 (PD-L1) vaccine in combination with nivolumab in 30 anti-PD-1 therapy naïve patients with metastatic melanoma (cohort A). We now report long-term follow-up of patients in cohort A. Further, we report results from cohort B, where the peptide vaccine was added to anti-PD-1 therapy for patients with progressive disease during anti-PD-1 treatment.

Methods:

All patients were treated with a therapeutic peptide vaccine in Montanide targeting IDO and PD-L1 combined with nivolumab (NCT03047928). A long-term follow-up of safety, response rates, and survival rates were performed in cohort A including patient subgroup analyses. Safety and clinical responses were analyzed for cohort B.

Results:

Cohort A: At data cut-off, January 5, 2023, the overall response rate (ORR) was 80%, and 50% of the 30 patients obtained a complete response (CR). The median progression-free survival (mPFS) was 25.5 months (95% CI 8.8 to 39), and median overall survival (mOS) was not reached (NR) (95% CI 36.4 to NR). The minimum follow-up time was 29.8 months, and the median follow-up was 45.3 months (IQR 34.8–59.2). A subgroup evaluation further revealed that cohort A patients with unfavorable baseline characteristics, including either PD-L1 negative tumors (n=13), elevated lactate dehydrogenase (LDH) levels (n=11), or M1c (n=17) obtained both favorable response rates and durable responses. The ORR was 61.5%, 79%, and 88% for patients with PD-L1−tumors, elevated LDH, and M1c, respectively. The mPFS was 7.1 months for patients with PD-L1−tumors, 30.9 months for patients with elevated LDH, and 27.9 months for M1c patients. Cohort B: At data cut-off, the best overall response was stable disease for 2 of the 10 evaluable patients. The mPFS was 2.4 months (95% CI 1.38 to 2.52), and the mOS was 16.7 months (95% CI 4.13 to NR).

Conclusion:

This long-term follow-up confirms the promising and durable responses in cohort A. Subgroup analyses of patients with unfavorable baseline characteristics revealed that high response rates and survival rates were also found in patients with either PD-L1 negative tumors, elevated LDH levels, or M1c. No meaningful clinical effect was demonstrated in cohort B patients.

Trial registration number:

NCT03047928.

2022-01-01·Theranostics

Polymer chimera of stapled oncolytic peptide coupled with anti-PD-L1 peptide boosts immunotherapy of colorectal cancer

Article

作者: Gao, Weidong ; Lin, Jiayi ; Nagle, Dale G ; Yang, Ting ; Zhang, He ; Jin, Jinmei ; Zhang, Weidong ; Zhang, Lijun ; Zhou, Yudong ; Luan, Xin ; Lu, Lu ; Chen, Hongzhuan ; Wu, Ye

Rationale: Scarce tumor mutation burden and neoantigens create tremendous obstacles for an effective immunotherapy of colorectal cancer (CRC). Oncolytic peptides rise as a promising therapeutic approach that boosts tumor-specific immune responses by inducing antigenic substances. However, the clinical application of oncolytic peptides has been hindered because of structural instability, proteolytic degradation, and undesired toxicity when administered systemically. Methods: Based on wasp venom peptide, an optimized stapled oncolytic peptide MP9 was developed with rigid α-helix, protease-resistance, and CRC cell cytotoxicity. By incorporating four functional motifs that include D-peptidomimetic inhibitor of PD-L1, matrix metalloproteinase-2 (MMP-2) cleavable spacer, and MP9 with 4-arm PEG, a novel peptide-polymer conjugate (PEG-MP9-aPDL1) was obtained and identified as the most promising systemic delivery vehicle with PD-L1 targeting specificity and favorable pharmacokinetic properties. Results: We demonstrated that PEG-MP9-aPDL1-driven oncolysis induces a panel of immunogenic cell death (ICD)-relevant damage-associated molecular patterns (DAMPs) both in vitro and in vivo, which are key elements for immunotherapy with PD-L1 inhibitor. Further, PEG-MP9-aPDL1 exhibited prominent immunotherapeutic efficacy in a CRC mouse model characterized by tumor infiltration of CD8+ T cells and induction of cytotoxic lymphocytes (CTLs) in the spleens. Conclusion: Our findings suggest that PEG-MP9-aPDL1 is an all-in-one platform for oncolytic immunotherapy and immune checkpoint blockade (ICB).

项与 etimumotide 相关的新闻（医药）

2025-03-27

·药明康德

2025“最具创新力”10大生物技术公司榜单出炉！

▎药明康德内容团队编辑近日，知名商业媒体《快公司》（Fast Company）揭晓了“2025年最具创新力的10家生物技术公司“榜单。本届榜单聚焦人工智能（AI）技术在生命科学领域的革命性应用，多家企业凭借其在AI药物发现、精准医疗方案设计和生物多样性保护等三大核心领域的突破性进展而入选。图片来源：123RF ALZpath：开发早期阿尔茨海默病早期诊断的血检方法 ALZpath公司成立于2020年，专注于开发阿尔茨海默病（AD）及相关痴呆症的创新诊断解决方案。尽管AD早期诊断具有重要临床价值，但传统诊断方法存在灵敏度不足、具创伤性检查、以及费用高昂等诸多局限性。该公司突破性地开发出一种专有抗体技术，能够通过血液检测，精准识别生物标志物p-tau217的浓度——该标志物被学术界公认为AD的可靠指标，但此前受限于技术瓶颈无法实现血检量化。由于p-tau217浓度变化可在AD患者的认知障碍出现前数年提示脑内病理性蛋白累积，这项技术为AD的早期干预提供了重要窗口。 2024年，ALZpath取得了多项重大发展。6月，罗氏（Roche）获得了其p-tau217抗体的独家授权，将用于开发商业化体外诊断产品。值得注意的是，罗氏公司基于该技术的检测方案已获得美国FDA突破性医疗器械认定（Breakthrough Device Designation），并将通过罗氏与礼来（Eli Lilly & Company）的战略合作内容实现商业化落地。同年，ALZpath还实现了另一重要里程碑——与医药企业、诊断机构及学术中心建立了超过50项活跃合作伙伴关系。 Basecamp Research：勘测地球微生物生物多样性并分享其价值 Basecamp Research是一家致力于通过AI技术革新蛋白质设计的生物技术公司。该公司通过其专有自然知识图谱训练AI进行蛋白质设计，为医药、食品和工业等领域提供生物解决方案。其独特之处在于将全球生物多样性数据与人工智能相结合，开辟了蛋白质设计的新范式。地球上只有不到1%的遗传生物多样性被记录下来，为填补这一知识空白，Basecamp Research正在开展针对遗传生物多样性的系统性探索，迄今为止，该公司已在五大洲进行了超过125次研究考察，建立了生物多样性基因组数据库，收录了来自火山喷口、洞穴系统、海洋、原始丛林等极端生态系统中的微生物基因序列和蛋白质数据。 Basecamp的创新平台实现了环境数据与蛋白质序列的智能整合。通过将温度、pH值等环境参数与蛋白质序列相结合，其AI模型能够更精准地预测蛋白质功能特性。这一AI模型已被应用于药物开发、工业酶设计和生物材料创新等领域。目前，公司已与赛诺菲（Sanofi）、宝洁（Procter & Gamble）、Johnson Matthey等50余家企业和机构建立了合作伙伴关系，通过技术授权模式推动商业化应用。此外，Basecamp Research还建立了创新的利益共享机制：通过追踪客户用于产品开发的蛋白质来源，并从研发阶段开始向相关社区支付特许权使用费，确保其发现所带来的益处能够公平地与为其平台提供本土生物多样性的社区共享。2024年8月，Basecamp Research宣布与喀麦隆达成新生物勘探协议，除支付特许权使用费外，还提供人员培训、设备支持、数据共享及教育项目等非货币利益。2024年10月，该公司成功完成了6000万美元B轮融资。 DarwinHealth：为癌症患者精准匹配精准治疗方案晚期癌症患者往往面临治愈率低、且标准治疗失败后选择有限的困境。由于肿瘤异质性和药物-癌症组合的复杂性，临床决策面临巨大挑战。如何从海量药物中筛选出最有效的治疗方案，成为精准医学亟待解决的关键问题。 DarwinHealth是一家临床阶段的生物技术公司，致力于通过其专有的系统生物学算法，为癌症患者匹配最优治疗方案。该公司的核心技术——VIPER人工智能算法，能够基于患者的肿瘤基因表达谱等实验数据，预测现有药物或疗法组合的潜在疗效。2024年，公司在其平台上进行了多项创新，加速了其在罕见和难治性恶性肿瘤患者群体的多项临床试验以及药物开发中的应用。包括百时美施贵宝（Bristol Myers Squibb）在内的多家客户已使用DarwinHealth的技术平台分析了1500多种肿瘤相关化合物。 2024年公布的试验结果显示，该公司的工具平台DarwinOncoTarget在预测乳腺癌患者对HDAC6抑制剂的应答方面准确率达100%，在预测多种肿瘤类型的应答方面准确率达91%。 GeneDX：为广泛新生儿群体提供罕见病基因筛查 GeneDx是一家专注于利用AI技术实现个体化基因诊断的科技公司。公司致力于通过创新基因组学解决方案来缩短罕见病的确诊时间。在传统诊疗模式下，罕见病的确诊平均需要5年时间，部分病例甚至长达10年。GeneDx的目标是加速这一进程，帮助患者及时获得精准诊疗方案。 2024年，GeneDx作为核心技术支持方，为GUARDIAN研究（全球大规模新生儿罕见病基因组筛查项目）提供了全流程测序及分析服务。此外，GeneDx还与纽约蒙特菲奥里罕见病中心（New York Center for Rare Diseases at Montefiore）、PacBio公司和Google Health等多家机构建立合作关系，为罕见病家庭提供基因诊断服务。目前，公司主要服务对象涵盖临床遗传学家、遗传咨询师及儿科专科医生等专业群体。未来，GeneDx期望推动新生儿基因组筛查成为标准医疗实践，使基因组检测成为基层儿科医生评估疑似罕见病患儿的一线检测工具，从根本上改变罕见病的诊疗范式。 IO Biotech：开发治疗黑色素瘤的双效免疫疗法 IO Biotech是一家处于临床阶段的生物医药公司，专注于开发创新“现货型”治疗性癌症疫苗。其核心技术平台T-win采用创新的癌症疫苗策略，旨在激活T细胞，使其能够同时靶向肿瘤细胞和肿瘤微环境中的免疫抑制细胞，从而更有效地发挥免疫系统的抗癌作用。与需要针对每位患者具体设计的个体化疫苗不同，IO Biotech的多肽疫苗采用“现货型”设计模式，使患者能够更快地获得治疗。公司的主要候选药物IO102-IO103被设计用于晚期黑色素瘤的初始治疗。在其与Keytruda联合治疗转移性黑色素瘤患者的1/2期临床研究中，该组合疗法展现出良好的临床疗效和安全性，总缓解率达80%，完全缓解率达到50%。这些出色的疗效数据使其获得了美国FDA授予的突破性疗法认定，并进入3期临床开发阶段。目前，IO102-IO103与Keytruda联合治疗的2期临床试验正在肺癌和头颈癌实体瘤患者中开展。此外，公司其他候选产品的临床前开发工作也在积极推进中。 Nabla Bio：利用AI从零开始构建新型抗体 Nabla Bio是一家融合人工智能与实验室技术的创新生物技术公司，专注于针对传统难以成药的靶点开发高选择性的功能性药物。多次跨膜蛋白占细胞表面蛋白的三分之二，是调控细胞行为的关键靶点。Nabla Bio的生成式蛋白设计平台通过AI驱动设计，有望解锁数百个此前被认为不可靶向的靶点，使可成药靶点数量实现倍增。2024年秋季，该公司发表论文，证明其AI平台仅需靶点蛋白序列和/或结构即可从头设计治疗性抗体，并成功靶向G蛋白偶联受体（GPCR），取得该领域的突破性进展。凭借这一技术优势，Nabla Bio已与阿斯利康（AstraZeneca）、百时美施贵宝和武田（Takeda）等大型药企达成总额超5.5亿美元的合作协议。公司自2021年成立以来快速发展，累计获得3700万美元风险投资，其中包括2024年1月完成的2600万美元A轮融资。其技术平台正推动抗体药物开发模式革新，为肿瘤、免疫等疾病领域带来新的治疗可能。 Protagonist Therapeutics：拓展多肽疗法的应用范围 Protagonist Therapeutics是一家临床阶段的生物医药公司，致力于开发基于多肽的新型疗法。多肽作为蛋白质的基本组成单元，具有强效、高选择性和良好的安全性特征，在胰岛素和肥胖症治疗等领域已得到广泛应用。然而，多肽药物在口服给药时面临重大挑战——药物在肠道中的快速降解导致其生物利用度低。Protagonist通过其专有技术平台，成功克服了这一难题，开发出具有口服生物利用度的多肽药物。公司的核心产品icotrokinra（JNJ-2113）是与强生（Johnson & Johnson）合作开发的口服多肽药物，在中重度斑块型银屑病的两项3期临床试验中已取得积极顶线结果。该药物另有3项3期试验正在进行，预计2025年第二季度公布数据。同时，该药治疗溃疡性结肠炎的2b期临床研究初步结果也将在2025年第一季度揭晓。另一款主打产品rusfertide是可注射合成肽，可模拟铁调节激素hepcidin的作用机制。2024年1月，该公司与武田达成全球许可与合作协议，共同开发rusfertide用于真性红细胞增多症治疗。 Recursion：用数据驱动药物发现 Recursion是一家临床阶段的生物技术公司，旨在通过使用机器学习与先进的实验室自动化流程来增强新型药物发现的能力。Recursion拥有大规模的实验能力（每周进行多达数百万次的实验）和强大的计算能力（拥有并运行世界上最强大的超级计算机之一），将技术、生物学和化学结合起来，推动未来医学的发展。2024年，该公司推出的LOWE（LLM-Orchestrated Workflow Engine）平台开创性地为复杂的药物发现任务提供了一个自然语言界面。该平台由Recursion的专有生物和化学数据提供支持，可以利用公司的自动化湿实验室协调实验。近年来，Recursion取得了一系显著进展。其神经科学“表象图谱（phenomap）”被基因泰克以3000万美元付款引进。此外，公司的研发管线也进展显著：其针对复发性艰难梭菌（C. diff）感染的非抗生素疗法REC-3964已进入2期临床试验；REC-1245（靶向RBM39的分子胶降解剂）已启动针对实体瘤/淋巴瘤的1/2期试验。2024年底，Recursion完成对Exscientia的战略收购后，公司内部处于临床前和临床开发阶段的药物总数达到10种。 Syncell：推动空间蛋白质组学研究进程 Syncell是一家处于商业化阶段的生命科学公司，专注于亚细胞蛋白质纯化和空间蛋白质组学分析。2024年，Syncell推出了超高灵敏度、实时靶向显微镜照明平台Microscoop，为研究癌症等疾病的空间蛋白质组学——即三维蛋白质表达研究带来了突破性进展。Microscoop平台利用显微镜引导的光标记技术，能够从疾病相关区域精准分离蛋白质，并通过质谱分析鉴定潜在的新药靶点，将空间蛋白质组学研究提升至全新精度水平。 Syncell提供包含专有试剂在内的完整解决方案，其技术平台在多个研究领域展现广泛适用性：不仅成功应用于阿尔茨海默病β淀粉样蛋白新型成分的发现、肌萎缩侧索硬化症（ALS）相关TDP-43聚集体的识别，还在三阴性乳腺癌标志物的发现等研究中取得进展。2024年12月，Syncell顺利完成1500万美元A轮融资。凭借其创新技术平台，Syncell正推动蛋白质组学研究向更高精度的亚细胞层面发展，为疾病机制研究和药物靶点发现提供强大工具。 10x Genomics：提升单细胞分析的速度与效能 10x Genomics致力于为学术界和工业界研究人员提供强大工具，以解析细胞和组织在三维空间中的分子活动。与传统群体细胞分析不同，10x的单细胞技术能够在单个细胞水平上研究基因组学、转录组学、蛋白质组学及细胞间相互作用，这种高分辨率分析方法对精准医学至关重要——特别是在癌症等由特定细胞异常驱动的疾病研究中，能够帮助科学家精确定位关键病变细胞。 2024年，公司在其单细胞和空间组学平台上推出了10种新产品和功能。其中，GEM-X微流控芯片设计显著提升了基因检测灵敏度和效率，同时显著降低单细胞分析成本。另一款产品Visium HD空间基因表达分析仪则实现了组织图像与单细胞级基因表达数据的精准叠加，为药物靶点发现提供全新维度。这些创新工具已被应用于多项重大科研项目，包括人类细胞图谱（Human Cell Atlas）等，持续推动单细胞研究向更高精度、更低成本的方向发展。 ▲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] These 10 biotech companies are changing how we discover new drugs and treat complex diseases, Retrieved March 26, 2025, from https://www.fastcompany.com/91269109/biotech-most-innovative-companies-2025 [2] 各公司官网免责声明：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/卖出突破性疗法

2025-03-25

·iobiotech.com

IO Biotech Announces Acceptance of Abstracts to be Presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting

• New non-clinical data strengthens evidence of contributions of IO102 and IO103 to tumor growth control through target specific T-cell activation, offering a distinct and complementary approach to checkpoint inhibitors• New preclinical data for IO170 add to growing body of evidence supporting the potential of immune-modulatory therapeutic cancer vaccines to treat a wide range of cancers NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announced that two abstracts have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place April 25-30 in Chicago, Illinois. One of the posters will share insights, using non-clinical models, related to IO Biotech’s lead investigational candidate, IO102-IO103, currently being evaluated in a pivotal Phase 3 trial in advanced melanoma. The second poster contains new preclinical data for the third candidate in the company’s pipeline, IO170, which targets transforming growth factor beta (TGF-beta). Additionally, Mads Hald Andersen, DMSc, PhD, Director of the Center for Cancer Immune Therapy (CCIT) and scientific co-founder of IO Biotech, will be chairing and speaking at an education session on cancer vaccines. “We are pleased to share new data at AACR that expand our understanding of the underlying mechanism of action of our lead candidate, IO102-IO103, currently being investigated in a pivotal Phase 3 trial,” said Ayako Wakatsuki Pedersen, PhD, Senior Vice President of Translational Research at IO Biotech. “We are also excited to share that we have seen promising activity for an additional candidate being studied in our pipeline, IO170. Together, the data from both of these non-clinical studies further solidify the potential of our proprietary T-win immune-modulatory cancer vaccine platform.” Dr. Pedersen continued, “We also look forward to the educational session on cancer vaccines, chaired by our scientific founder, that will explore the latest advances in cancer vaccine research and the distinct mechanisms of action of different approaches and their potential to reshape cancer immunotherapy.” Presentation Details Title: Immune-modulatory therapeutic cancer vaccines against IDO1 and PD-L1 control tumor growth through target specific changes in the tumor microenvironmentAbstract Number: 2241Date and Time: Monday, April 28, 2025, 9:00 AM – 12:00 PM CTLocation: Poster Section 38Poster Board Number: 12Presenter: Marion Chapellier, PhD Title: A TGFβ-directed immune-modulatory vaccine induces T cell activation and drives antitumor activity by modulating the tumor microenvironmentAbstract Number: 2257Date and Time: Monday, April 28, 2025, 9:00 AM – 12:00 PM CTLocation: Poster Section 38Poster Board Number: 28Presenter: Justin Joseph, PhD Education Session: Immune Modulatory Vaccines This session will explore the latest advancements in cancer vaccine research, spanning from preclinical innovation to clinical translation.Session: ED59. Cancer Vaccines 101Date and Time: Saturday, April 26, 2025, 12:30 – 2:00 pm CTSession format and speakers: Dr. Smita Nair (30 min, including discussion) Dr. Kristen Radford (30 min, including discussion) Dr. Mads Hald Andersen (30 min, including discussion) About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead investigational cancer vaccine candidate, Cylembio® (imsapepimut and etimupepimut, adjuvanted) also known as IO102-IO103 in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), has been granted a Breakthrough Therapy Designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech). Cylembio is a trademark of IO Biotech ApS. Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing or outcome of primary analysis of the company’s Phase 3 trial, other current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Contact: InvestorsMaryann Cimino, Director of Investor Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com MediaJulie FunestiEdelman917-498-1967julie.funesti@edelman.com

疫苗临床3期突破性疗法

2024-12-29

·药事纵横

5750万欧元！一家Biotech推进“癌症疫苗”研发

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。近日，一家丹麦生物制药公司IO Biotech 宣布已从欧洲投资银行获得高达 5750 万欧元的贷款，用于推进其治疗性癌症疫苗，包括 IO102-IO103，预计于 2025 年提交生物制品许可申请 (BLA)。这笔贷款包括三笔承诺贷款，总额为 3750 万欧元，以及一笔非承诺贷款，总额为 2000 万欧元。预计将使该公司的现金流延长至 2026 年第二季度。 IO Biotech 首席财务官 Amy Sullivan 表示：“欧洲投资银行的支持将促进其癌症疫苗候选物的开发和商业化。该笔贷款是无担保的，没有最低现金要求，每笔贷款期限为六年期，并计算计息。” IO Biotech成立于2014年，总部位于丹麦，公司专注于开发免疫肿瘤学疗法，利用独特的T细胞疫苗技术来激活患者的免疫系统，以针对并摧毁癌细胞。基于对肿瘤微环境（TME）以及肿瘤逃避免疫系统监视和攻击能力的深入理解，该公司开发了专有的T-win技术平台，旨在激活天然存在的T细胞，靶向并直接杀伤免疫抑制细胞和肿瘤细胞。IO Biotech于2021年11月5日上市，目前，市值为5995万美元。研发管线 IO Biotech主要候选产品 IO102-IO103 是一种现成的治疗性癌症疫苗，分别靶向IDO和PD-L1，适应症包括: 晚期黑色素瘤和非小细胞肺癌（NSCLC）。除此之外，IO102-IO103还有多项临床试验中正在测试中。最新的III期试验中期报告显示PFS有显著优势，但是OS尚未达到统计学差异。公司计划于2025年完成试验。此次融资举措凸显了欧洲投资银行对欧盟创新生物技术企业的支持，也反映了 IO Biotech 在生物制药领域的进步。参考资料： https://iobiotech.com/press-releases/?workflow=8842c69a-1a06-4b0b-a34f-e4c021f4c8d9

疫苗临床3期免疫疗法并购

100 项与 etimumotide 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
鳞状细胞癌	临床2期	美国	The Johns Hopkins University	2020-12-26
骨髓增生性疾病	临床2期	丹麦	University Hospital Maastricht	2019-07-27
慢性淋巴细胞白血病	临床2期	丹麦	Herlev Hospital	2019-04-07
阴燃多发性骨髓瘤	临床2期	丹麦	Herlev Hospital	2019-02-18
阴燃多发性骨髓瘤	临床2期	丹麦	IO Biotech ApS	2019-02-18
基底细胞癌	临床2期	丹麦	Herlev Hospital	2018-11-01
黑色素瘤	临床2期	丹麦	Herlev Hospital	2018-01-30
滤泡性淋巴瘤	临床1期	丹麦	Herlev Hospital	2018-01-02
多发性骨髓瘤	临床1期	丹麦	Herlev Hospital	2017-02-01

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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


WCLC2022	N/A	-	43	PD-1 inhibitor	選積範構網壓願鬱獵積(餘餘醖淵製獵憲壓積鹹) = 壓齋簾範廠艱淵鏇網廠積顧窪製糧鏇製餘構願 (衊獵糧衊蓋遞憲簾糧鹹 ) 更多	-	2022-08-06
WCLC2022	N/A	-	43	PD-L1 inhibitor	選積範構網壓願鬱獵積(餘餘醖淵製獵憲壓積鹹) = 夢膚網衊顧簾壓觸糧簾積顧窪製糧鏇製餘構願 (衊獵糧衊蓋遞憲簾糧鹹 ) 更多	-	2022-08-06
NCT03714529 (Pubmed \| Cancers (Basel)) 人工标引	临床2期	基底细胞癌	10	IO103	獵糧築獵鹽窪壓餘網鬱(蓋鏇鑰壓襯鬱襯顧簾製) = 9/10 induced in blood samples and 5/9 in skin-infiltrating lymphocytes 憲鬱鑰壓鹽廠鬱襯壓積 (蓋網艱顧構齋蓋網鹹網 ) 更多	积极	2021-02-22
NCT03042793 (Pubmed \| Front Immunol) 人工标引	临床1期	多发性骨髓瘤	10	IO103	齋構憲簾鬱壓襯構獵鏇(鹹鑰積製範鹽積築築觸) = below CTCAE grade 3, and most were grade 1-2 injection site reactions 網獵膚構膚製艱廠觸選 (顧網選願蓋鬱顧衊糧壓 )	积极	2020-11-09
ASCO2015	N/A	胸腺上皮肿瘤	29	Chemotherapy	願鬱鹽鹹選膚築築願鬱(鹹繭製憲構窪廠糧簾鬱) = 衊築襯觸鬱顧遞窪蓋觸願積繭繭襯鬱鏇醖獵襯 (餘醖糧廠憲簾膚願選鹽 )	-	2015-05-20