This phase Ib/II trial evaluates the safety and effect of the Nous-209 vaccine in Lynch syndrome patients. Lynch syndrome is an inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before the age of 50. In Lynch syndrome, errors in the genetic information inside cells are not properly corrected. When that happens, the cells produce new proteins called neoantigens. Neoantigens are recognized by the body's immune system as foreign, and the body tries to get rid of them. Nous-209 is a vaccine made with man-made copies of some of those neoantigens. This trial aims to see whether the Nous-209 vaccine is safe to give to patients with Lynch syndrome, whether people are able to take the Nous-209 vaccine without becoming too uncomfortable, and how the immune system of patients with Lynch syndrome respond to the Nous-209 vaccine. This trial may help researchers determine whether receiving Nous-209 have an effect on the development of polyps or tumors in the colon.

开始日期2022-11-10

申办/合作机构

National Cancer Institute

NCT04041310

/ Active, not recruiting临床1/2期

A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

Ref: Protocol v9.0, dated 7Nov2023. NOUS-209-01 is a multicenter, open-label, multiple cohorts, clinical study, designed to evaluate safety, tolerability, and immunogenicity, and to detect any preliminary evidence of anti-tumor activity of Nous-209 genetic polyvalent vaccine plus pembrolizumab combination therapy in adult subjects with unresectable or metastatic deficient mismatch repair (dMMR) or MSI-H CRC, gastric, or gastro-esophageal junction (G-E junction) tumors. Nous-209 is based on a heterologous prime/boost regimen composed of the Great Ape Adenovirus GAd20-209-FSP used for priming and Modified Vaccinia virus Ankara MVA-209-FSP used for boosting. The Phase I portion of the study is a first-in-human (FIH) clinical study with a primary objective to elucidate the safety and tolerability of Nous-209 in addition to establishing the recommended Phase 2 dose (RP2D), whereas the Phase II was introduced to assess efficacy as the primary objective.

开始日期2019-10-21

申办/合作机构

Nouscom AG

[+1]

100 项与 MVA-209-FSP 相关的临床结果

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100 项与 MVA-209-FSP 相关的转化医学

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100 项与 MVA-209-FSP 相关的专利（医药）

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项与 MVA-209-FSP 相关的文献（医药）

2020-09-15·Cancer research1区 · 医学

A Genetic Vaccine Encoding Shared Cancer Neoantigens to Treat Tumors with Microsatellite Instability

1区 · 医学

Article

作者: Merone, Rossella ; Mori, Federica ; Troise, Fulvia ; Langone, Francesca ; Yadav, Mahesh ; van der Bruggen, Pierre ; Vanhaver, Cristophe ; Tucci, Fabio Giovanni ; De Lucia, Maria ; Vitale, Rosa ; Folgori, Antonella ; Colloca, Stefano ; D'Alise, Anna Morena ; Ruzza, Valentino ; Catanese, Maria Teresa ; Leuzzi, Adriano ; Nicosia, Alfredo ; Lahm, Armin ; Garzia, Irene ; Di Matteo, Elena ; Bignone, Veronica ; Gordon-Alonso, Monica ; Abbate, Adele ; Diodoro, Maria Grazia ; Soprana, Elisa ; Scarselli, Elisa ; Siccardi, Antonio ; Cotugno, Gabriella ; Fichera, Imma ; Leoni, Guido ; Panigada, Maddalena

Abstract:

Tumors with microsatellite instability (MSI) are caused by a defective DNA mismatch repair system that leads to the accumulation of mutations within microsatellite regions. Indels in microsatellites of coding genes can result in the synthesis of frameshift peptides (FSP). FSPs are tumor-specific neoantigens shared across patients with MSI. In this study, we developed a neoantigen-based vaccine for the treatment of MSI tumors. Genetic sequences from 320 MSI tumor biopsies and matched healthy tissues in The Cancer Genome Atlas database were analyzed to select shared FSPs. Two hundred nine FSPs were selected and cloned into nonhuman Great Ape Adenoviral and Modified Vaccinia Ankara vectors to generate a viral-vectored vaccine, referred to as Nous-209. Sequencing tumor biopsies of 20 independent patients with MSI colorectal cancer revealed that a median number of 31 FSPs out of the 209 encoded by the vaccine was detected both in DNA and mRNA extracted from each tumor biopsy. A relevant number of peptides encoded by the vaccine were predicted to bind patient HLA haplotypes. Vaccine immunogenicity was demonstrated in mice with potent and broad induction of FSP-specific CD8 and CD4 T-cell responses. Moreover, a vaccine-encoded FSP was processed in vitro by human antigen-presenting cells and was subsequently able to activate human CD8 T cells. Nous-209 is an “off-the-shelf” cancer vaccine encoding many neoantigens shared across sporadic and hereditary MSI tumors. These results indicate that Nous-209 can induce the optimal breadth of immune responses that might achieve clinical benefit to treat and prevent MSI tumors.

Significance::

These findings demonstrate the feasibility of an “off-the-shelf” vaccine for treatment and prevention of tumors harboring frameshift mutations and neoantigenic peptides as a result of microsatellite instability.

Vaccines

Development of a Potency Assay for Nous-209, a Multivalent Neoantigens-Based Genetic Cancer Vaccine

Article

作者: Allocca, Simona ; Ruzza, Valentino ; Petrone, Anna Maria ; Garzia, Irene ; Merone, Rossella ; Lanzaro, Francesca ; Cotugno, Gabriella ; Bignone, Veronica ; Vitale, Rosa ; D’Alise, Anna Morena ; Bartolomeo, Rosa ; Sdruscia, Giulia ; Troise, Fulvia ; Siani, Loredana ; Leoni, Guido ; Colloca, Stefano ; Romano, Giuseppina ; Scarselli, Elisa

Quality control testing of vaccines, including potency assessment, is critical to ensure equivalence of clinical lots. We developed a potency assay to support the clinical advancement of Nous-209, a cancer vaccine based on heterologous prime/boost administration of two multivalent viral vector products: GAd-209 and MVA-209. These consist of a mix of four Adeno (Great Ape Adenovirus; GAd) and four Modified Vaccinia Ankara (MVA) vectors respectively, each containing a different transgene encoding a synthetic polypeptide composed of antigenic peptide fragments joined one after the other. The potency assay employs quantitative Reverse Transcription PCR (RT-Q-PCR) to quantitatively measure the transcripts from the four transgenes encoded by each product in in vitro infected cells, enabling simultaneous detection. Results showcase the assay’s robustness and biological relevance, as it effectively detects potency loss in one component of the mixture comparably to in vivo immunogenicity testing. This report details the assay’s setup and validation, offering valuable insights for the clinical development of similar genetic vaccines, particularly those encoding synthetic polypeptides.

项与 MVA-209-FSP 相关的新闻（医药）

2025-11-10

·癌度

《癌度快报》2025年11月10日！

临床试验病友交流群（点击）一、新药快讯 1、国产个性化mRNA疫苗AK154来了，联合双抗破解胰腺癌“冷肿瘤”困境 2025年11月10日，国产自研个性化mRNA疫苗AK154用于胰腺癌术后辅助治疗的Ⅰ期临床完成首例患者给药。该疫苗通过测序肿瘤组织的基因突变来筛选新抗原，根据基因突变制备个性化的mRNA疫苗，旨在逆转胰腺癌“免疫沙漠”的特性，诱导T细胞产生免疫应答。在该临床试验中AK154将单药或联合PD-1/CTLA-4双抗卡度尼利、PD-1/VEGF双抗依沃西使用，临床前研究显示AK154具有较强的免疫原性及良好的抗肿瘤活性和安全性。而胰腺癌的新抗原丰富但免疫细胞浸润不足，因此个性化疫苗联合免疫疗法有望为术后胰腺癌患者提供新防治策略。 2、预防癌症，现货型癌症疫苗NOUS-209在林奇综合征携带者公布疗效数据！近日，现货型癌症疫苗NOUS-209在林奇综合征携带者中的Ib/2期临床试验数据公布，NOUS-209是一种旨在拦截癌症发生的预防性免疫疗法，通过专有的病毒载体平台递送209种在微卫星不稳定性高（MSI-H）肿瘤中广泛存在的共享移码肽新抗原，训练人体免疫系统识别并清楚癌前以及癌变细胞。林奇综合征是常见的遗传综合征，具有较高发生结直肠癌、子宫内膜癌的风险。林奇综合征预期年发病率为4%，而每年一次的NOUS-209随访期间内未检出任何新的高级别腺瘤。预防了癌症的发生。 3、肿瘤完全消失持续超过2年时间，创新单抗药AU-007的2期临床公布结果代号为AU-007的imneskibart是一款通过人工智能设计的抗体药物，对IL-2中的CD25结合位点有高度选择性，该药避免了其他IL-2疗法所导致的负反馈抑制反应，使得免疫系统更偏向激活而非抑制。该药还显著减少高剂量IL-2治疗中常见的毛细血管渗透综合征和肺水肿风险，该药对于多线治疗且对PD-1耐药的黑色素瘤带来深度肿瘤缩小，在非小细胞肺癌也观察到客观缓解，AU-007联合低计量阿地白介素治疗膀胱癌和头颈癌，有患者肿瘤病灶消失持续时间超过2年。二期临床试验仍在进行中！二、抗癌前沿 1、让癌细胞被自己的“垃圾”毒死，有望治疗卵巢癌、肺癌、脑癌和血癌近日，美国维克森林大学团队开发出了新型小分子WF-242，该分子通过特异性抑制过氧化物还原酶3（PRX3）蛋白，可以阻断癌细胞对过氧化氢的降解能力，诱导活性氧（ROS）累积到能摧毁癌细胞的致死水平。这个研究是源自对天然抗癌物质硫链丝菌素的片段优化，体外实验显示对卵巢癌、肺癌、脑癌、前列腺癌及血液肿瘤均有效，二期较原来的硫链丝菌素选择性更高、潜在毒性更低。该研究发表于《自然·化学生物学》，这为氧化应激靶向疗法提供了一个新的方向，目前这一发现正在被推进至临床前的转化研究。 11月份福利癌度联手吉因加，推出“吉爱3000”惠民检项目，最低2000+可及的基因检测专属福利，详情微信扫码联系下方小助手进行免费咨询。咨询全球新药临床试验、报告解读同样可以扫描下面二维码咨询！另外，由于微信公众平台的机制调整，恳请各位粉丝朋友花一两秒钟帮我们点亮文章下方的【小手】和【爱心】，这对我们至关重要。谢谢大家！点亮小手爱心，送来温暖鼓励

临床2期信使RNA疫苗临床1期免疫疗法

2025-11-09

·药明康德

有望预防癌症的现货型免疫疗法；有望抑制烟瘾的小分子药物获批临床…… | 一周盘点

本期看点 1. 现货型癌症疫苗NOUS-209在林奇综合征（LS）携带者中的1b/2期临床试验数据积极，展现出预防LS相关初发和复发癌症的潜力。 2. 口服非阿片类镇痛候选药物VVZ-2471的IND申请已获得美国FDA批准，该药不仅有望缓解神经病理性疼痛，还具备抑制成瘾相关行为的潜力。 NOUS-209：公布1b/2期临床试验的新数据 Nouscom公司公布了其现货型癌症疫苗NOUS-209在林奇综合征携带者中的1b/2期临床试验新数据。NOUS-209是一种旨在“拦截癌症”于发生前的预防性免疫疗法，利用公司专有的病毒载体平台递送209种在微卫星不稳定性高（MSI-H）肿瘤中广泛存在的共享移码肽（FSP）新抗原，训练免疫系统识别并清除癌前及癌变细胞。LS是最常见的遗传性癌症综合征，显著增加结直肠癌、子宫内膜癌等多种癌症风险，目前缺乏有效的药物预防手段。研究显示，每年一次的NOUS-209重复治疗可安全、有效地增强LS携带者持久的T细胞免疫应答。在临床效果方面，尽管基线时4.7%的受试者存在需切除的高级别腺瘤（按标准治疗已清除），但在治疗后一年随访期内未检出任何新的高级别腺瘤，而该人群预期年发病率约为4%。该结果首次提供了NOUS-209具有癌症预防潜力的临床证据。此外，对原发及异时性MSI肿瘤的分析证实，NOUS-209靶向的大量FSP新抗原持续存在，支持其在预防LS相关初发和复发癌症中的广泛应用前景。 VVZ-2471：IND申请获得FDA许可 Vivozon公司宣布，其口服非阿片类镇痛候选药物VVZ-2471的IND申请已获得美国FDA批准，启动针对吸烟者的1b期临床试验。VVZ-2471是一种双重受体拮抗剂，可同时阻断血清素5-HT2A受体和mGluR5受体，通过调节神经系统兴奋性，不仅有望缓解神经病理性疼痛，还具备抑制成瘾相关行为的潜力。目前，该药物正在韩国开展针对神经病理性疼痛患者的2期临床试验，并已于今年9月被美国国立卫生研究院（NIH）下属的国家药物滥用研究所（NIDA）选为阿片类药物成瘾（OUD）的治疗开发项目。 SPY003：公布1期临床试验的中期数据 Spyre Therapeutics公司公布了其在研长效单克隆抗体SPY003的积极1期临床试验中期数据。SPY003是一种靶向IL-23 p19亚基的延长半衰期抗体，旨在用于治疗炎症性肠病（IBD），包括溃疡性结肠炎和克罗恩病。该药基于Spyre的长效抗体平台开发，具备支持每季度甚至每年两次皮下给药的潜力。此次公布的数据来自一项随机、双盲、安慰剂对照的1期研究，共纳入59名健康成人受试者。SPY003在所有剂量水平下均表现出良好的耐受性，安全性特征与同类抗IL-23药物一致，仅报告两例≥2级治疗相关不良事件（均判定与药物无关），无严重不良事件；最常见的治疗期间不良事件为头痛。关键药代动力学数据显示，SPY003的半衰期约为85天，有望通过单次皮下注射实现每季度或每年两次的维持给药方案。此外，未观察到抗药抗体对药代动力学产生明显影响。参考资料： [1] Vesper Bio announces positive Phase Ib/IIa topline results for lead candidate VES001 for frontotemporal degeneration. Retrieved November 7, 2025, from https://www.prnewswire.com/news-releases/vesper-bio-announces-positive-phase-ibiia-topline-results-for-lead-candidate-ves001-for-frontotemporal-degeneration-302600150.html [2] 비보존, '비마약성 진통제' 1b상 "美 IND 승인". Retrieved November 7, 2025, from https://www.biospectator.com/news/view/26828 [3] Caribou Biosciences Announces Positive Data from ANTLER Phase 1 Trial Demonstrating Efficacy and Durability of Vispa-cel (CB-010), an Allogeneic CAR-T Cell Therapy, on Par with Autologous CAR-T Cell Therapies. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/03/3179104/0/en/Caribou-Biosciences-Announces-Positive-Data-from-ANTLER-Phase-1-Trial-Demonstrating-Efficacy-and-Durability-of-Vispa-cel-CB-010-an-Allogeneic-CAR-T-Cell-Therapy-on-Par-with-Autolog.html [4] Benitec Biopharma Provides Positive Interim Clinical Study Results for BB-301 Phase 1b/2a Clinical Trial and Receives FDA Fast Track Designation for BB-301. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/03/3179118/0/en/Benitec-Biopharma-Provides-Positive-Interim-Clinical-Study-Results-for-BB-301-Phase-1b-2a-Clinical-Trial-and-Receives-FDA-Fast-Track-Designation-for-BB-301.html [5] Caribou Biosciences Announces Positive Data from CaMMouflage Phase 1 Trial of CB-011 in Multiple Myeloma. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/03/3179047/0/en/Caribou-Biosciences-Announces-Positive-Data-from-CaMMouflage-Phase-1-Trial-of-CB-011-in-Multiple-Myeloma.html [6] Valneva Reports Positive Results for Phase 1 Trial of Second-Generation Zika Vaccine Candidate. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/04/3179950/0/en/Valneva-Reports-Positive-Results-for-Phase-1-Trial-of-Second-Generation-Zika-Vaccine-Candidate.html [7] New Phase I Immunological Data Presented at SITC 2025 Support TG4050’s Potential Role in Preventing Cancer Relapse. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/04/3180650/0/en/New-Phase-I-Immunological-Data-Presented-at-SITC-2025-Support-TG4050-s-Potential-Role-in-Preventing-Cancer-Relapse.html [8] Spyre Therapeutics Announces Positive Interim Phase 1 Results for SPY003, Its Novel, Half-Life Extended anti-IL-23 Antibody. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/04/3180812/0/en/Spyre-Therapeutics-Announces-Positive-Interim-Phase-1-Results-for-SPY003-Its-Novel-Half-Life-Extended-anti-IL-23-Antibody.html [9] Diakonos Oncology Presents Promising Preliminary Data from Phase 1 Study of DOC1021 Cell-Based Immunotherapy in Pancreatic Cancer at Society for Immunotherapy of Cancer 40th Annual Meeting. Retrieved November 7, 2025, from https://www.prnewswire.com/news-releases/diakonos-oncology-presents-promising-preliminary-data-from-phase-1-study-of-doc1021-cell-based-immunotherapy-in-pancreatic-cancer-at-society-for-immunotherapy-of-cancer-40th-annual-meeting-302608210.html [10] Ankyra Announces Publication of Phase 1 Clinical Data, and Will Present at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Retrieved November 7, 2025, from https://ankyratx.com/press-releases/ankyra-announces-publication-of-phase-1-clinical-data-and-will-present-at-the-society-for-immunotherapy-of-cancer-sitc-annual-meeting/ [11] 한미약품, 'UCN2 유사체' 비만 "美1상 IND 승인". Retrieved November 7, 2025, from https://www.biospectator.com/news/view/26883 [12] TREOS Bio Announces Publication of Phase 1b Clinical Trial Results of PolyPEPI1018 Plus TAS-102 in Refractory MSS mCRC in JCO Oncology Advances. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/06/3182356/0/en/TREOS-Bio-Announces-Publication-of-Phase-1b-Clinical-Trial-Results-of-PolyPEPI1018-Plus-TAS-102-in-Refractory-MSS-mCRC-in-JCO-Oncology-Advances.html [13] 4DMT Announces Positive Long-Term Data from Phase 1/2 PRISM Clinical Trial in Wet AMD Supporting 4D-150’s Potential as a Backbone Therapy with Consistent and Durable Benefit over Multiple Years. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/06/3182290/0/en/4DMT-Announces-Positive-Long-Term-Data-from-Phase-1-2-PRISM-Clinical-Trial-in-Wet-AMD-Supporting-4D-150-s-Potential-as-a-Backbone-Therapy-with-Consistent-and-Durable-Benefit-over-M.html [14] Assembly Biosciences Presents Positive Phase 1b Data for Next-Generation Capsid Assembly Modulator ABI-4334 at AASLD The Liver Meeting. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/07/3183614/16259/en/Assembly-Biosciences-Presents-Positive-Phase-1b-Data-for-Next-Generation-Capsid-Assembly-Modulator-ABI-4334-at-AASLD-The-Liver-Meeting.html [15] Immunocore presents Phase 1 data for hepatitis B candidate at AASLD’s The Liver Meeting. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/07/3183593/0/en/Immunocore-presents-Phase-1-data-for-hepatitis-B-candidate-at-AASLD-s-The-Liver-Meeting.html [16] Nouscom Presents New Positive Phase 1/2b data of NOUS-209 at SITC 2025, Supporting Plans to Initiate Registration-Enabling Study for Cancer Interception in Lynch Syndrome Carriers. Retrieved November 7, 2025, from https://www.globenewswire.com/news-release/2025/11/07/3183707/0/en/Nouscom-Presents-New-Positive-Phase-1-2b-data-of-NOUS-209-at-SITC-2025-Supporting-Plans-to-Initiate-Registration-Enabling-Study-for-Cancer-Interception-in-Lynch-Syndrome-Carriers.html 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

临床申请免疫疗法临床1期临床2期疫苗

2025-10-30

·PRNewswire

Clinical Late-Breaking Abstracts Announced for the Society for Immunotherapy of Cancer's 40th Anniversary Annual Meeting

MILWAUKEE, Oct. 30, 2025 /PRNewswire/ -- The Society for Immunotherapy of Cancer (SITC) received an incredible number of abstract submissions in 2025, more than 1,300, including many clinical based Late-breaking Abstracts. SITC is proud to announce the titles and authors for the clinical Late-breaking Abstracts (LBA) . The abstracts will be presented at SITC's upcoming 40th Anniversary Annual Meeting & Pre-Conference Programs taking place Nov. 5–9, 2025, in National Harbor, MD and virtually. Continue Reading SITC 2025 Logo "We are excited to incorporate these clinical abstracts into an already impressive lineup of abstracts that will be presented at SITC. The Late-breaking Abstracts this year will only focus on late-breaking data from interventional clinical trials in humans and will further enhance the cutting-edge science offered at the 40th Anniversary Annual Meeting," said SITC Vice President Sandra Demaria MD. "SITC is committed to accelerating the approval of 100 novel agents by 2034, and providing a platform to showcase the latest clinical advancements at our Annual Meeting is an important component of this goal." The Late-breaking Abstracts with oral presentations at the 40th Anniversary Annual Meeting are: (1316) Initial monotherapy clinical activity of invikafusp alfa, a first-in-class TCR β-chain-targeted bifunctional antibody, in tissue-agnostic, TMB-H patients from STARt-001, a Phase 1/2 trial Aurélien Marabelle, MD, PhD – Gustave Roussy & Paris Saclay University Session 104: Clinical Oral Abstract Session – Friday, Nov. 7, 2025 – 11:30 a.m. ET (1342) First-in-human dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and initial efficacy of mRNA-LNP MT-302 in vivo CAR therapy in solid tumors Rasha Cosman, BSc (Med), MBBS, FRACP – St. Vincent's Hospital Session 104: Clinical Oral Abstract Session – Friday, Nov. 7, 2025 – 11:30 a.m. ET (1348) Final overall survival analysis of HARMONi-A study comparing ivonescimab plus chemotherapy to chemotherapy alone in patients with EGFR+ NSCLC progressed on EGFR-TKI treatment Li Zhang, MD – Sun Yat-Sen University Cancer Center Session 104: Clinical Oral Abstract Session – Friday, Nov. 7, 2025 – 11:30 a.m. ET (1305) Coformulation of favezelimab and pembrolizumab as neoadjuvant therapy for resectable cutaneous squamous cell carcinoma (cSCC): results from cohort A of the phase 2 KeyForm-010 study Matteo Carlino, MBBS, PhD, BMedSC, FRACP – The University of Sydney Session 106a: Considerations for Incorporating Biomarkers in Perioperative/Neoadjuvant Therapy – Friday, Nov. 7, 2025 – 1:45 p.m. ET (1346) Molecular and immunologic correlates of response in a phase II study of neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma Kenneth Tsai, MD, PhD – Moffitt Cancer Center Session 106a: Considerations for Incorporating Biomarkers in Perioperative/Neoadjuvant Therapy – Friday, Nov. 7, 2025 – 1:45 p.m. ET (1327) Biomarker and updated clinical data for RP1 plus nivolumab in anti-PD-1-failed melanoma from the IGNYTE trial demonstrate reversal of mechanisms of resistance to immune checkpoint blockade Trisha Wise-Draper, MD, PhD– University of Cincinnati Cancer Center Session 107d: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics – Friday, Nov. 7, 2025 – 3:55 p.m. ET (1328) SSGJ-707, a PD-1/VEGF bispecific antibody, combined with platinum-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC): results from a phase 2 study Lin Wu, PhD –Hunan Cancer Hospital Session 107d: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics – Friday, Nov. 7, 2025 – 3:55 p.m. ET (1310) A phase 1/IIa study of ILKN421H, a LNP mRNA encoding an IL2Rβγ selective IL-2v, as monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors Haining Huang, PhD- ILeukon Therapeutics Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1325) SCOPE, an open label phase 2 parallel multi cohort clinical trial evaluating an off-the-shelf DNA plasmid vaccine in first line advanced melanoma combined with check point blockade - interim read-out Nermeen Varawalla, MD, PhD, MBA – Scancell Ltd Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1336) Final ph1b/2 results for Nous-209 monotherapy in Lynch syndrome carriers: Annual revaccination boosts T cell immunity informing future cancer interception strategies Anna Morena D'Alise, PhD – Nouscom SRL Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1340) Lead-in therapy targeting PD1 and/or LAG3 distinguishes differential impacts upon the immune response in first-line treatment of metastatic melanoma Lilit Karapetyan, MD – Moffitt Cancer Center Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1345) Initial phase 1a/1b results of STK-012, an α/β IL-2 receptor biased partial agonist, with pembrolizumab, pemetrexed, and carboplatin in 1L PD-L1 negative non-squamous NSCLC Adam Schoenfeld, MD – Memorial Sloan-Kettering Cancer Center Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET The full Regular and Young Investigator Award abstracts will be available on Nov. 4 at 9 a.m. ET and LBA – Clinical Only abstracts will be made available on Nov. 7 at 9 a.m. ET. Both types of abstracts will be published in the Journal for ImmunoTherapy of Cancer (JITC) Clinical Late-breaking Abstract Sessions with oral abstract presentations will take place on Friday, Nov. 7 from 11:30 a.m.–12:15 p.m. CT and Saturday, Nov. 8 from 1:45–3 p.m. ET in the Gaylord National Resort and Convention Center - Ballroom Level - Potomac Ballroom. In addition, Late-breaking Abstract posters will be presented in the Exhibit and Poster Hall and the virtual ePoster Hall beginning Friday, Nov. 7 at 10 a.m. ET. To learn more about the Late-breaking Abstracts, visit the 40th Annual Meeting & Pre-Conference Programs website. To register for the 40th Anniversary Annual Meeting and Pre-Conference Programs, click here. About SITC The Society for Immunotherapy of Cancer (SITC) is the world's leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Established in 1984, SITC, a 501(c)(3) not-for-profit organization, serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Through educational programs that foster scientific exchange and collaboration, SITC aims to one day make the word cure a reality for cancer patients everywhere. To learn more, visit and follow us on X, LinkedIn, Facebook and YouTube. SOURCE Society for Immunotherapy of Cancer (SITC) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床结果免疫疗法疫苗

100 项与 MVA-209-FSP 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
遗传性非息肉病性结直肠癌	临床2期	美国	National Cancer Institute	2022-11-10
胃食管交界处癌	临床2期	美国	Nouscom AG	2019-10-21
胃食管交界处癌	临床2期	比利时	Nouscom AG	2019-10-21
胃食管交界处癌	临床2期	加拿大	Nouscom AG	2019-10-21
胃食管交界处癌	临床2期	意大利	Nouscom AG	2019-10-21
胃食管交界处癌	临床2期	西班牙	Nouscom AG	2019-10-21
胃食管交界处癌	临床2期	英国	Nouscom AG	2019-10-21
MSI 癌症	临床2期	美国	Nouscom AG	2019-10-21
MSI 癌症	临床2期	比利时	Nouscom AG	2019-10-21
MSI 癌症	临床2期	加拿大	Nouscom AG	2019-10-21

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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


NCT04041310 (ESMO2025)	临床2期	错配修复缺陷或微卫星高度不稳定性结直肠癌 dMMR \| MSI-H	22	Nous-209 plus pembrolizumab	願鏇襯獵窪願廠構餘蓋(衊蓋網夢鹽獵製觸繭窪) = 繭齋齋窪鏇遞蓋糧選齋艱衊願鹹顧鬱製醖夢顧 (簾淵醖構鑰蓋鏇繭鏇鏇 ) 更多	积极	2025-10-17
NCT05078866 (Nous-209, AACR2025)	临床1/2期	遗传性非息肉病性结直肠癌 MSH2 pathogenic germline variants	45	Nous-209	艱觸膚廠鹹選醖夢糧鬱(淵觸淵鏇餘艱廠簾積構) = Fatigue was observed in 78% post-prime and 51% post-boost 壓範壓獵選憲鹽顧餘積 (繭獵遞蓋築襯簾憲獵壓 ) 更多	积极	2025-04-29
NCT05078866 (1526, SITC2023)	临床1/2期	遗传性非息肉病性结直肠癌 MSI \| DNA mismatch repair (MMR) genes \| frameshift peptide (FSP) neoantigens	21	Nous-209 genetic vaccine	鹹蓋膚淵廠膚壓壓繭襯(製憲鏇簾糧鬱壓淵艱積) = 蓋膚網製製膚蓋構淵鑰築鹹憲鬱鹽艱壓觸顧艱 (壓網範蓋繭鹽窪鏇構糧 )	积极	2023-10-31
NCT04041310 (NOUS-209-01, ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	错配修复缺陷或微卫星高度不稳定性结直肠癌一线 Deficient DNA Mismatch Repair (dMMR) \| MSI-High	7	Pembrolizumab+NOUS-209	糧衊餘窪選顧願窪醖遞(膚獵憲觸積鏇鬱蓋蓋鏇) = 鏇鏇鬱鬱積齋膚鹹製築襯範齋範範鏇艱廠膚鏇 (膚醖繭窪獵夢夢鬱觸範 ) 更多	积极	2023-05-26
NCT04041310 (SITC 12022 \| SITC 22022) 人工标引	临床1期	Turcot综合征一线 Deficient DNA Mismatch Repair (dMMR) \| MSI-H	12	pembrolizumab+Nous-209 (dose level 1)	餘壓艱範鏇醖願遞獵蓋(觸淵齋簾膚顧艱構簾衊) = 遞鹽夢餘窪觸夢廠網製選襯範齋膚衊顧鬱鏇憲 (衊淵憲膚廠醖獵衊鹽積 ) 更多	积极	2022-09-27
NCT04041310 (SITC 12022 \| SITC 22022) 人工标引	临床1期	Turcot综合征一线 Deficient DNA Mismatch Repair (dMMR) \| MSI-H	12	pembrolizumab+Nous-209 (dose level 2)	餘壓艱範鏇醖願遞獵蓋(觸淵齋簾膚顧艱構簾衊) = 選艱觸顧淵鬱鬱願蓋窪選襯範齋膚衊顧鬱鏇憲 (衊淵憲膚廠醖獵衊鹽積 ) 更多	积极	2022-09-27
NCT04041310 (ESMO2021) 人工标引	临床1期	Turcot综合征 Deficient DNA Mismatch Repair (dMMR) \| MSI	6	pembrolizumab+Nous-209	糧顧夢憲壓鹽鏇齋膚繭(齋淵壓廠夢積網齋選壓) = None 襯簾網襯願鬱網夢壓衊 (鬱選構獵蓋壓糧窪構簾 )	积极	2021-09-16