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更新于：2026-04-25

ONCOS-102

更新于：2026-04-25

概要

概要

基本信息

药物类型

溶瘤病毒

别名

AD5/3-D24-GMCSF、ADV5/3-D24-GM-CSF、CGTG-102

+ [1]

靶点

CSF-2R

作用方式

刺激剂

作用机制

CSF-2R刺激剂(粒细胞 - 巨噬细胞集落刺激因子受体复合体刺激剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Ludwig Institute for Cancer Research Ltd.

非在研机构

MedImmune LLC

Circio Holding ASA

Targovax Oy

+ [1]

权益机构

Circio Holding ASA

Agenus, Inc.

Merck & Co., Inc.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)、快速通道 (美国)

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关联

项与 ONCOS-102 相关的临床试验

NCT05561491

/ Withdrawn临床2期

An Open-Label, Two-Part, Dose-Exploration and Multiple Expansion, Phase 2 Study of ONCOS-102 in Combination With Novel Immune-Targeted Anti-Cancer Agents in Patients With Unresectable or Metastatic Cutaneous Melanoma Resistant to Anti-PD-(L)1 Treatment

A Phase 2 study investigating the efficacy and safety of ONCOS-102 alone or in combination with balstilimab (a programmed death receptor-1 [PD-1] inhibitor).

开始日期2024-01-01

申办/合作机构

Targovax Oy

[+1]

NCT02963831

/ Completed临床1/2期IIT

A Phase 1/2 Dose Escalation Study With Expansion Cohorts to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies

This is a two-part Phase 1/2 dose escalation and dose expansion study of an Adenovirus Vector (Ad5/3-D24-GMCSF), Expressing GM-CSF (GM-CSF-encoding adenovirus), ONCOS-102, in combination with anti-programmed death ligand-1 (PD-L1) antibody, durvalumab, in adult subjects with peritoneal disease who have failed prior standard chemotherapy and have histologically confirmed epithelial ovarian cancer or metastatic colorectal cancer.

开始日期2017-09-07

申办/合作机构

Ludwig Institute for Cancer Research Ltd.

[+3]

NCT03003676

/ Completed临床1期

A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After PD1 Blockade

This is a multi center, phase I pilot study of sequential ONCOS-102 and pembrolizumab in patients with advanced or unresectable melanoma progressing after PD1 blockade. The primary objective of the study is to determine the safety of sequential treatment with ONCOS-102 followed by pembrolizumab. The protocol aims to enroll patients into two cohorts: Part I: up to 12 patients will receive sequential treatment with ONCOS-102 followed by pembrolizumab. Part II: up to 12 patients will receive an initial treatment phase with ONCOS-102 followed by a treatment phase with ONCOS-102 in combination with pembrolizumab.

开始日期2016-12-01

申办/合作机构

Targovax Oy

100 项与 ONCOS-102 相关的临床结果

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100 项与 ONCOS-102 相关的转化医学

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100 项与 ONCOS-102 相关的专利（医药）

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项与 ONCOS-102 相关的文献（医药）

2023-01-04·Clinical cancer research : an official journal of the American Association for Cancer Research

ONCOS-102: A Step Forward or Sideways?

Communications

作者: Levi, Shoshana T. ; Boland, Genevieve M.

Summary:

Treatment of anti–PD-1 refractory melanoma remains a challenge. Intratumoral injection of ONCOS-102, a chimeric oncolytic adenovirus expressing GMCSF, into anti–PD-1–resistant melanoma with administration of pembrolizumab was safe and effective. Response to therapy was associated with increased lymphocyte infiltration and expression of cytotoxicity and costimulatory genes.See related article by Shoushtari et al., p. 100

2023-01-04·Clinical cancer research : an official journal of the American Association for Cancer Research

Pilot Study of ONCOS-102 and Pembrolizumab: Remodeling of the Tumor Microenvironment and Clinical Outcomes in Anti–PD-1–Resistant Advanced Melanoma

Communications

作者: Shoushtari, Alexander N. ; Hornyak, Thomas J. ; Olszanski, Anthony J. ; Hansen, Thomas B. ; Nyakas, Marta ; Levitsky, Victor ; Jäderberg, Magnus ; Wolchok, Jedd D. ; Kuryk, Lukasz

Abstract:

Purpose::

Intratumoral oncolytic virotherapy may overcome anti–PD(L)-1 resistance by triggering pro-inflammatory remodeling of the tumor microenvironment. This pilot study investigated ONCOS-102 (oncolytic adenovirus expressing GM-CSF) plus anti–programmed cell death protein 1 (PD)-1 therapy in anti–PD-1–resistant melanoma.

Patients and Methods::

Patients with advanced melanoma progressing after prior PD-1 blockade received intratumoral ONCOS-102 either as priming with 3 doses (3 × 1011 viral particles) during Week 1 [Part 1 (sequential treatment)] or as 4-dose priming and 8 booster doses every 3 weeks [Part 2 (combination treatment)]. From Week 3, all patients received pembrolizumab every 3 weeks (≤8 doses). The primary endpoint was safety. Objective response rate (ORR), progression-free survival, and immunologic activation in repeat biopsies were also investigated.

Results::

In 21 patients (Part 1, n = 9; Part 2, n = 12) ONCOS-102 plus pembrolizumab was well tolerated: most adverse events (AE) were mild/moderate in severity. Pyrexia (43%), chills (43%), and nausea (28%) were the most common ONCOS-102–related AEs. There were no dose-limiting toxicities. ORR was 35% [response evaluation in solid tumors (RECIST) 1.1, irRECIST]. Reduction in size of ≥1 non-injected lesions observed in 53% patients indicated a systemic effect. In injected tumors, persistent immune-related gene expression and T-cell infiltration were associated with clinical benefit. Viral persistence and efficacy in injected and non-injected lesions without additional toxicity supported Part 2 dosing regimen in future studies.

Conclusions::

ONCOS-102 plus pembrolizumab was well tolerated and led to objective responses in patients with anti–PD-1–resistant advanced melanoma. ONCOS-102 promoted T-cell infiltration, particularly cytotoxic CD8+ T cells, which persisted at Week 9, driving clinical benefit. Further investigation of ONCOS-102 plus PD-1 blockade is warranted.See related commentary by Levi and Boland, p. 3

2020-08-01·Journal of medical virology4区 · 医学

Chimeric oncolytic Ad5/3 virus replicates and lyses ovarian cancer cells through desmoglein‐2 cell entry receptor

4区 · 医学

Article

作者: Kuryk, Lukasz ; Møller, Anne‐Sophie W.

Abstract:

Despite new therapies, the estimated 229 875 women living with ovarian cancer have a 5‐year survival rate of 47.6%. This cavity‐localized cancer lends itself to local administration of modalities, such as the oncolytic adenovirus (Ad) Ad5/3‐D24‐granulocyte‐macrophage colony‐stimulating factor virus (ONCOS‐102). Its repeated administration to a patient with chemotherapy‐refractory ovarian cancer induced CD8+ antitumor immune responses with the overall survival reaching 40 months. Here we probe the dominant receptor used by ONCOS‐102 in four established epithelial ovarian cancer cell lines. Ad3 can use the desmoglein‐2 (DSG2) and CD46 receptors on susceptible cells. DSG2 was nearly absent in A2780 cells but was expressed in more than 90% of OAW42, OVCAR3, and OV‐90 cells. After 96 hours, ONCOS‐102 treatment showed significant oncolytic activity (≧50%) in OAW42, OVCAR3, and OV‐90 cells, but minimal activity in A2780 cells, suggesting DSG2 as the dominant receptor for ONCOS‐102. Furthermore, retrospective analyses of phase I clinical trial of ONCOS‐102 treatment of 12 patients with varied tumors indicated a correlation between viral genomes in blood and DSG2 RNA expression. These data support the role of DSG2 expression on cancer cells in virus infectivity and the continued development of ONCOS‐102 for ovarian cancer treatment.

项与 ONCOS-102 相关的新闻（医药）

2026-03-30

·Cancer Research Hub

1. 文章信息 Title: Immunotherapy resistance and strategies in malignant pleural mesothelioma 题目：恶性胸膜间皮瘤免疫治疗耐药机制与应对策略通讯作者：李胜桥通讯机构：中山大学附属第五医院引用格式： Xia W, Zhang Y, Zhao J, Tan X, Ju S, Zou W, Chen C, Li C, Xu Y, Peng Y, Li S. Immunotherapy resistance and strategies in malignant pleural mesothelioma. Cancer Drug Resist. 2026;9:9. https://dx.doi.org/10.20517/cdr.2025.215 2. 图文摘要恶性胸膜间皮瘤（malignant pleural mesothelioma, MPM）是最具侵袭性的胸部恶性肿瘤之一，对手术、化疗及放疗等传统治疗手段普遍表现出显著耐受性，致使总体预后长期不理想。免疫检查点抑制剂（immune checkpoint inhibitors, ICIs）的引入在一定程度上重塑了MPM的治疗范式。既往多项I/II期临床研究表明，程序性细胞死亡蛋白1（programmed cell death protein 1, PD-1）与细胞毒性T淋巴细胞相关抗原4（cytotoxic T-lymphocyte-associated antigen 4, CTLA-4）的联合阻断较单药治疗可获得更优的抗肿瘤活性，并已确立为一线治疗的重要策略。然而，获得性及原发性耐药的高发生率仍构成限制疗效进一步提升的核心瓶颈。该耐药表型主要源于MPM特有的生物学特征，包括高度免疫抑制的肿瘤微环境（TME）、多条致癌信号通路的异常激活以及复杂的代谢重编程过程，上述因素协同构建了抵御免疫清除的多层级防御网络。基于此，当前研究逐步转向机制驱动的精准联合治疗策略探索。通过将ICIs与抗血管生成治疗、细胞毒性化疗、代谢干预手段以及新一代细胞免疫疗法（如嵌合抗原受体T细胞CAR-T和嵌合抗原受体自然杀伤细胞CAR-NK）进行理性整合，旨在多维度重塑肿瘤免疫生态，突破免疫逃逸屏障并恢复有效的抗肿瘤免疫应答。与此同时，新型预测性与分层生物标志物的持续发现及其与多组学数据的整合分析，正推动MPM患者分层管理向更高精度演进，预示着个体化免疫治疗时代的加速到来。本文系统梳理了MPM免疫治疗领域的最新临床进展与基础研究成果，重点解析免疫耐药的多因素机制网络。在此基础上，进一步构建了面向下一代治疗模式的前瞻性框架，并对多种新兴治疗策略的转化潜力进行了系统评估，包括针对精氨酸琥珀酸合成酶1（argininosuccinate synthetase 1, ASS1）缺陷肿瘤的精氨酸剥夺疗法、CAR-T细胞治疗、T细胞受体融合构建物以及溶瘤病毒疗法。通过将上述创新治疗模式与生物标志物驱动的患者筛选策略相结合，本文勾勒了MPM治疗从经验性决策向精准免疫肿瘤学转型的潜在路径，其最终目标在于实现对这一高度难治性肿瘤的持久性疾病控制与生存获益的实质性提升。 3. 文章亮点 01 免疫微环境：从"冷"到"热"的多维屏障 Figure 1 恶性胸膜间皮瘤中 T 细胞介导的免疫抵抗的关键驱动因素 MPM的肿瘤微环境（TME）以免疫抑制为突出特征。M2型肿瘤相关巨噬细胞（TAMs）、调节性T细胞（Tregs）及髓源性抑制细胞（MDSCs）在TME中显著富集，通过分泌IL-10、TGF-β及精氨酸酶-1，抑制T细胞的活化与增殖。VEGF驱动的异常血管生成进一步阻碍T细胞向肿瘤实质内浸润，形成免疫排斥型微环境。与此同时，肿瘤细胞通过上调PD-L1、Galectin-9、B7-H3等抑制性分子，削弱T细胞的效应功能。此外，TGF-β信号通路可抑制主要组织相容性复合体I类分子（MHC-I）的表达，并促进成纤维细胞活化，从物理屏障与功能抑制两方面共同构成抗肿瘤免疫的阻碍。临床启示：针对TME的多靶点干预已在BEAT-meso III期临床试验中显示出协同效应。该研究中，阿替利珠单抗联合贝伐珠单抗及化疗方案对比贝伐珠单抗联合化疗方案，中位无进展生存期（PFS）分别为9.2个月与7.6个月（HR=0.72），且在非上皮样亚组中观察到更为显著的总生存期（OS）获益（HR=0.51）。 02 代谢重编程：精氨酸剥夺开辟新战场 Figure 2 克服恶性胸膜间皮瘤免疫治疗耐药性的策略 MPM，尤其是非上皮样亚型，常伴有精氨酸琥珀酸合成酶1（ASS1）缺失，发生率约为50%-60%。ASS1缺失导致肿瘤细胞丧失内源性精氨酸合成能力，对外源性精氨酸形成高度依赖。这一代谢脆弱性不仅限制了肿瘤细胞在精氨酸缺乏环境下的生长，更在肿瘤微环境（TME）中加剧了肿瘤细胞与T细胞之间对精氨酸的代谢竞争。髓源性抑制细胞（MDSCs）通过高表达精氨酸酶-1进一步消耗局部精氨酸，加剧T细胞微环境中的精氨酸剥夺，从而抑制T细胞活化与效应功能。临床启示：ATOMIC-Meso III期临床试验证实，在ASS1缺失的MPM患者中，聚乙二醇化精氨酸脱亚胺酶（ADI-PEG20）联合化疗相较于安慰剂联合化疗，显著改善了患者的总生存期（中位OS：9.3个月 vs. 7.7个月，HR=0.71，95%CI：0.56-0.89）与无进展生存期（中位PFS：6.2个月 vs. 5.6个月，HR=0.65，95%CI：0.51-0.83）。该研究为靶向肿瘤代谢脆弱性的免疫调节策略提供了高级别临床证据。 03 细胞免疫疗法：从"补充"到"重塑" Figure 3 针对恶性胸膜间皮瘤的细胞免疫疗法 MPM免疫治疗耐药的核心瓶颈之一在于肿瘤特异性T细胞在肿瘤微环境（TME）中浸润不足及功能耗竭。以嵌合抗原受体T细胞（CAR-T）、T细胞受体融合构建T细胞（TRuC-T）以及携带抗PD-1纳米抗体的装甲型CAR-T（NAC-T）为代表的新一代细胞免疫疗法，通过区域递送（如胸膜腔输注）直接将大量肿瘤特异性效应细胞输送至病灶部位，有效突破了T细胞募集受限与局部耗竭的双重障碍。临床启示：MSKCC I/II期试验（NCT02414269）：在复发/难治性MPM患者中，采用胸膜腔内输注iCasp9-M28z CAR-T细胞联合帕博利珠单抗治疗，中位总生存期（OS）达23.9个月，近40%的患者体内CAR-T细胞持续存在超过100天，显示出良好的持久性与协同效应。 NAC-T首次人体研究：在11例复发MPM患者中，NAC-T（抗MSLN装甲型CAR-T）治疗后客观缓解率（ORR）达63.6%，疾病控制率（DCR）为100%，中位OS达25.6个月，且未观察到剂量限制性毒性（DLT），提示该策略在逆转局部免疫抑制方面具有显著潜力。 TRuC-T（gavo-cel，NCT03585764）：在MSLN阳性晚期MPM患者中，TRuC-T细胞疗法显示出可控的安全性与初步抗肿瘤活性，ORR为21%，中位无进展生存期（PFS）为5.6个月，中位OS范围为11.2至13.7个月。 04 溶瘤病毒与疫苗策略：点燃"冷肿瘤"免疫火种溶瘤病毒（如ONCOS-102、HSV1716）通过选择性感染肿瘤细胞并诱导免疫原性细胞死亡（immunogenic cell death, ICD），释放肿瘤抗原及损伤相关分子模式（damage-associated molecular patterns, DAMPs），进而激活树突状细胞（dendritic cells, DCs）并促进T细胞向肿瘤微环境（TME）内募集，实现免疫学上“冷”肿瘤向“热”肿瘤的转化。树突状细胞疫苗则通过在体外负载肿瘤抗原后回输，直接增强抗原提呈能力，以弥补内源性抗原提呈不足。临床启示：ONCOS-102联合化疗：在一项随机II期研究中，ONCOS-102联合化疗相较于单纯化疗，客观缓解率（ORR）分别为30%与未报告，疾病控制率（DCR）达90%。中位无进展生存期（PFS）为9.8个月，中位总生存期（OS）为25.0个月（对照组为13.5个月，HR未达预设统计学边界）。联合治疗显著增加肿瘤内CD8⁺ T细胞浸润，并上调肿瘤细胞PD-L1表达，为后续免疫检查点抑制剂（ICI）的序贯应用提供了“启动-加强”（prime-boost）策略的机制基础。 DENIM试验（DC疫苗维持治疗）：该随机II/III期研究评估了肿瘤裂解物负载的自体树突状细胞疫苗作为一线化疗后维持治疗的疗效。结果显示，DC疫苗组中位OS为11.9个月，2年OS率约为50%-55%，未观察到新的安全性信号，支持DC疫苗在维持治疗阶段的应用潜力。 05 生物标志物与精准分层：从经验走向个体化 MPM患者对免疫检查点抑制剂（ICI）的治疗应答存在显著异质性，亟待建立有效的生物标志物体系以指导精准患者筛选。目前研究表明，组织学亚型（非上皮样）、BAP1突变状态（与“炎症型”免疫表型及ICI敏感性相关）、CDKN2A缺失（与免疫荒漠化表型及耐药相关）、ASS1表达水平以及外周血T细胞受体（TCR）克隆性等指标均显示出潜在的预测价值。与此同时，人工智能（AI）驱动的数字病理分析与液体活检技术正逐步纳入临床决策路径。临床启示：基于多组学数据的整合模型与AI辅助病理分析正推动MPM治疗模式从“经验性用药”向“机制导向的精准免疫肿瘤学”转变。CheckMate 743 III期试验进一步证实，非上皮样亚型患者从纳武利尤单抗联合伊匹木单抗的双免疫治疗中获益最为显著（中位OS：18.1个月 vs. 8.8个月，HR=0.46），确立了组织学亚型作为当前临床实践中最具可操作性的分层生物标志物。未来，随着多模态生物标志物体系的成熟，免疫治疗将从单一指标驱动走向多维动态指导的个体化决策。 4. 结论与展望 MPM免疫治疗耐药的形成，是肿瘤内在基因组变异（BAP1、NF2、CDKN2A）、代谢重编程（ASS1缺陷、精氨酸竞争）与肿瘤微环境（TME）免疫抑制（Tregs、MDSCs、CAFs、TGF-β）多维因素协同作用的结果。单靶点干预难以实现持久疗效，未来的突破方向或将集中于以下方面： 01 建立多模态联合治疗框架整合免疫检查点抑制剂与抗血管生成治疗（如BEAT-meso研究模式）、代谢干预（如ATOMIC-Meso研究模式）以及细胞免疫疗法（如CAR-T、NAC-T区域递送），实现多重机制协同。 02 发展空间多组学与动态液体活检技术支撑治疗响应与耐药演变的实时监测，推动患者分层策略由静态向动态演进。 03 推进区域性递送系统与纳米药物研发利用胸膜腔内CAR-T、功能性硒纳米颗粒（LET-SeNPs）等区域性或纳米级递送平台，提升局部疗效的同时降低全身毒性暴露。 5. 作者简介 01 通讯作者李胜桥，副主任医师，硕士生导师，中山大学“百人计划”引进人才。2008年至2016年任比利时鲁汶大学医学院移植实验室及IVAP公司研究员。擅长中西医结合治疗免疫性疾病，致力于免疫排斥反应抑制机理、免疫耐受诱导及新型免疫抑制剂筛选开发。2008获比利时鲁汶大学医学院医学博士学位。 02 第一作者夏婉怡，中山大学附属第五医院研究生在读，研究方向为药物抗肿瘤免疫调控机制研究。点击文末“阅读原文”阅读、下载全文【相关阅读】 CDR专题征稿｜天津医科大校长郝继辉教授，天津肿瘤医院胰腺中心主任余俊教授，副研究员周天兴领衔：克服胰腺癌治疗耐药 CDR | 美国MD安德森癌症中心George A. Calin团队最新综述—微小RNA是癌症耐药性的关键调节因子 CDR | 郑大一附院首席科学家韩新巍携手北京协和医学院刘灶渠特刊征稿：整合多组学和人工智能来破解癌症耐药性 CDR｜美国国家科学院院士Michael M. Gottesman团队最新研究：鉴定作为ATP结合盒药物外排转运蛋白底物的抗体药物偶联物载荷点击阅读2024-2025 CDR 出版文章【CDR 文章出版表（持续更新中）】关于期刊 Cancer Drug Resistance (CDR, Online ISSN: 2578-532X) 是由OAE Publishing Inc. 于 2018 年创办的一本国际化、经同行评审的金色开放获取（OA）期刊，致力于发表癌症耐药性领域的基础、转化和临床研究前沿成果，为全球学者提供高水平的交流平台。期刊最新影响因子IF 2024: 5.2, 位列肿瘤分类Q1区, 全球前20%期刊；最新CiteScore 2024: 8.3。CDR 期刊创刊至今始终坚持高标准的国际化办刊原则，坚持高质量内容出版的办刊方针，吸引了来自美国国家科学院院士，美国国家癌症研究所，美国国立卫生研究院，美国加州大学洛杉矶分校，英国伦敦国王学院，英国伦敦大学学院，荷兰阿姆斯特丹大学医学中心，美国杜克大学医学中心，德国波恩大学，新加坡国立大学，美国西奈山伊坎医学院，中国上海交通大学，丹麦哥本哈根大学等 56 位来自11个国家/地区的知名机构/大学的学者加入期刊编委会，助力期刊发展。CDR 期刊的稿件出版周期平均100天以内，诚挚欢迎领域内科研人员投稿，投稿网址：https://www.oaecenter.com，编辑部邮箱：cdr.eo@cancerdrugresist.net。加入CDR | 添加编辑部微信添加编辑部官方微信（请备注“姓名+机构+研究兴趣”），投稿咨询、加入期刊学者群。长按扫描二维码 |直达期刊首页了解更多期刊最新资讯长按扫描二维码 | 浏览最新文章列表了解癌症耐药最新研究进展

2023-01-18

·PRNewswire

Significant Positive Shift in the Malignant Pleural Mesothelioma Market with 5.7% CAGR During the Study Period (2019-2032) Expected by Analysts at DelveInsight

The dynamics of the malignant pleural mesothelioma market are anticipated to change in the coming years owing to the increasing awareness and expected increase in investment in the R&D activities. Companies like AstraZeneca (Imfinzi), Hoffmann-La Roche (Tecentriq (Atezolizumab) Plus Avastin (Bevacizumab), Sellas Life Sciences Group (GALINPEPIMUT-S), PharmaMar (Lurbinectedin, and Trabectedin), and several others are investigating their candidates for malignant pleural mesothelioma treatment. LAS VEGAS, Jan. 18, 2023 /PRNewswire/ -- DelveInsight's Malignant Pleural Mesothelioma Market Insights report includes a comprehensive understanding of current treatment practices, malignant pleural mesothelioma emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Malignant Pleural Mesothelioma Market Report As per DelveInsight analysis, the malignant pleural mesothelioma market size in the 7MM was approximately USD 280 million in 2021. According to the assessment done by DelveInsight, the estimated total malignant pleural mesothelioma incident cases in the 7MM were approximately 10.8K in 2021. Globally, leading malignant pleural mesothelioma companies such as Amphera BV, Polaris Pharmaceuticals, Sellas Life Sciences Group, Momotaro-Gene, PharmaMar, AstraZeneca, Targovax, TCR2 Therapeutics, Hoffmann-La Roche, Novartis, MolMed, Ys Therapeutics, Merck Sharp & Dohme Corp., Kissei Pharmaceutical Co., Ltd., NovoCure Ltd, AGC Biologics S.p.A, Aduro Biotech, Inc, Bristol-Myers Squibb, Novotech (Australia) Pty Limited, Kyorin Pharmaceuticals, ACADIA Pharmaceuticals, and others are developing novel malignant pleural mesothelioma drugs that can be available in the malignant pleural mesothelioma market in the coming years. The promising malignant pleural mesothelioma therapies in the pipeline include MesoPher, Pegargiminase, Galinpepimut-S (Vaccine), MTG201 + nivolumab, ZEPZELCA (lurbinectedin), IMFINZI, ONCOS-102, TC-210, TECENTRIQ Plus AVASTIN , and others. In December 2022, efficacy and safety data from the phase II/III DENIM trial in Mesothelioma were released by Amphera. In September 2022, Pegargiminase received Fast track status from the US FDA for Mesothelioma. In June 2022, Momotaro-Gene announced that it completed the enrolment in its phase II trial for Mesothelioma (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in the USA (Intratumoural). In 2015, the US FDA granted Orphan Drug Designation for MTG-201 for the treatment of malignant mesothelioma. Discover which therapies are expected to grab the major malignant pleural mesothelioma market share @ Malignant Pleural Mesothelioma Market Report Malignant Pleural Mesothelioma Overview Mesothelioma is a rare, aggressive form of malignant tumor that develops in the lining of the lungs, abdomen, or heart after inhaling asbestos fibers. Pleural mesothelioma is a cancer of the pleura, which is the mesothelium that surrounds the lungs. It is the most common type of mesothelioma, accounting for most diagnosed cases. Because men are more likely to be exposed to asbestos, they are more likely to develop mesothelioma. Asbestos exposure is the leading cause of pleural mesothelioma. Asbestos is a mineral group that occurs naturally as bundles of tiny fibers. These fibers can be found in soil and rocks all over the world. Malignant pleural mesothelioma symptoms include chest pain, bloody coughing, difficulty swallowing, dry cough, fluid in the lungs, dyspnea, fever, weight loss, and fatigue. Pleural mesothelioma is frequently diagnosed through a series of tests, including one or more imaging scans, such as an X-ray or CT scan, performed first to identify tumors or metastasis (spreading of disease). Malignant Pleural Mesothelioma Epidemiology Segmentation DelveInsight estimates that there were approximately 10.8K incident cases of malignant pleural mesothelioma in the 7MM in 2021. In the EU5 countries, the highest number of incident cases of MPM was found in the United Kingdom in 2021, followed by Germany and Italy, respectively. The malignant pleural mesothelioma market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Incident Cases of Mesothelioma Total Incident Cases of MPM Total Type-specific Cases of MPM Total Incident Cases of MPM Segmented by Age and Gender Total Incident Cases of MPM by Stages Total Treated Cases of MPM Download the report to understand which factors are driving malignant pleural mesothelioma epidemiology trends @ Malignant Pleural Mesothelioma Epidemiological Insights Malignant Pleural Mesothelioma Treatment Market The malignant pleural mesothelioma treatment aims to prolong life, manage symptoms, alleviate pain, and kill cancer cells. When treating malignant pleural mesothelioma, doctors will use a combination of different treatment options to remove as much of cancer as possible. Malignant pleural mesothelioma treatment options currently include chemotherapy, radiation, and surgery. Multimodal therapy refers to the use of multiple approaches by specialists. MPM patients who are diagnosed early benefit the most from surgery. Currently, two main procedures for MPM management are used: pleurectomy and decortication (P/D) and extrapleural pneumonectomy (EPP). Chemotherapy is the most commonly used malignant pleural mesothelioma treatment. Patients with unresectable cancer are frequently treated with palliative systemic chemotherapy. Alimta (pemetrexed) and cisplatin are the most effective combination of mesothelioma drugs. The first drug regimen, nivolumab and ipilimumab, were approved by the US FDA in 2020 for the treatment of adult patients with unresectable malignant pleural mesothelioma. The EMA also approved nivolumab in combination with ipilimumab for the first-line treatment of adult patients with inoperable malignant pleural mesothelioma. Later, in August 2021, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved the combination. To know more about malignant pleural mesothelioma treatment guidelines, visit @ Malignant Pleural Mesothelioma Management Malignant Pleural Mesothelioma Pipeline Therapies and Key Companies MesoPher: Amphera BV Pegargiminase: Polaris Pharmaceuticals Galinpepimut-S (Vaccine): Sellas Life Sciences Group MTG201 + nivolumab: Momotaro-Gene ZEPZELCA (lurbinectedin): PharmaMar IMFINZI: AstraZeneca ONCOS-102: Targovax TC-210: TCR2 Therapeutics TECENTRIQ Plus AVASTIN: Hoffmann-La Roche Learn more about the FDA-approved malignant pleural mesothelioma drugs @ Drugs for Malignant Pleural Mesothelioma Treatment Malignant Pleural Mesothelioma Market Dynamics The dynamics of the malignant pleural mesothelioma market are anticipated to change in the future due to the increasing awareness and expected increase in investment in the R&D activities by the leading pharma companies. In addition, the malignant pleural mesothelioma clinical pipeline is robust, with several therapies in development across a wide range of drug classes/technologies, including monoclonal antibodies, gene therapy, vaccines, and small molecules. Moreover, advances have been made in recent years, such as a better understanding of molecular pathogenesis and the immunological tumor microenvironment. Furthermore, clinical studies investigating systemic therapies for MPM continue to grow. These trials are primarily concerned with immunotherapy, either alone or in combination with other immunotherapies and non-immunotherapies. Thus, significant progress has been made in terms of therapies, pathophysiology, and diagnosis, all of which are expected to contribute to the upcoming malignant pleural mesothelioma market. Furthermore, the frontline setting is still relatively untapped (only a few approved therapies) and can provide lucrative opportunities for several companies to explore the malignant pleural mesothelioma market. However, early detection of MPM is difficult due to the lack of specific symptoms and long latency period (i.e., 20 to 50 years), making current screening approaches ineffective in diagnosing patients at early disease stages, with the majority of patients diagnosed in later or advanced stages. Moreover, the current gold standard of treatment, Alimta, is set to lose malignant pleural mesothelioma market exclusivity in the United States this year, which will significantly impact the sales value of Alimta as well as other emerging drugs in combination with pemetrexed. Thus, these factors will likely to impede the growth of the malignant pleural mesothelioma market. Scope of the Malignant Pleural Mesothelioma Market Report Therapeutic Assessment: Malignant Pleural Mesothelioma current marketed and emerging therapies Malignant Pleural Mesothelioma Market Dynamics: Malignant Pleural Mesothelioma market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Malignant Pleural Mesothelioma Market Access and Reimbursement Discover more about malignant pleural mesothelioma drugs in development @ Malignant Pleural Mesothelioma Clinical Trials Table of Contents Related Reports Malignant Pleural Mesothelioma Epidemiology Forecast Malignant Pleural Mesothelioma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted malignant pleural mesothelioma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Malignant Pleural Mesothelioma Pipeline Malignant Pleural Mesothelioma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant pleural mesothelioma companies, including TCR2 Therapeutics, Hoffmann-La Roche, Novartis, MolMed, Ys Therapeutics, Merck Sharp & Dohme Corp., Kissei Pharmaceutical Co., Ltd., among others. Mesothelioma Market Mesothelioma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key mesothelioma companies, including Amphera, AstraZeneca, Hutchmed, Momotaro-Gene Inc., Sanofi, among others. Mesothelioma Pipeline Mesothelioma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key mesothelioma companies, including Amphera, AstraZeneca, Hutchmed, Momotaro-Gene Inc., Sanofi, among others. Malignant Mesothelioma Market Malignant Mesothelioma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key malignant mesothelioma companies, including Epizyme, Ys Therapeutics, Novartis, Bayer, RS Oncology, among others. Malignant Mesothelioma Pipeline Malignant Mesothelioma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant mesothelioma companies, including Epizyme, Ys Therapeutics, Novartis, Bayer, RS Oncology, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

快速通道免疫疗法孤儿药上市批准临床2期

2022-05-31

·GlobeNewswire-Health Care

Agenus Advances Portfolio with 6 Clinical Collaborations

LEXINGTON, Mass., May 31, 2022 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, today announced that it has entered into 3 new clinical collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis, doubling its current number of clinical collaborations. These 6 collaborations span a range of Agenus’ clinical assets, including botensilimab (Fc-enhanced anti-CTLA-4), balstilimab (anti-PD-1), zalifrelimab (anti-CTLA-4), and QS-21 STIMULON™. Agenus is pursuing partnerships with companies developing agents with complementary mechanisms, paving the way for promising immunotherapy combinations to address immunosuppression in the tumor microenvironment. The combination studies are being sponsored and executed by our collaborators, with drug supply and scientific support provided by Agenus. This strategy, enabled by in-house integrated manufacturing and scientific capabilities, positions Agenus to achieve the insights and advances needed to drive development on accelerated timelines. “These new collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis are exciting next steps in our partnership strategy to broaden combinations and indications under evaluation with our immunomodulatory antibodies,” said Dr. Steven O’Day, Chief Medical Officer at Agenus. “We believe these combinations may unlock the power of immunotherapy more broadly, potentially offering new and promising benefit to patients with treatment-resistant solid tumors.” Agenus’ new and ongoing clinical collaborations are supporting and enabling: Targovax to conduct a clinical trial combining botensilimab and balstilimab with ONCOS-102 (oncolytic virus) in patients with PD-1 relapsed/refractory melanoma. ONCOS-102 is designed to induce immune activation and immunogenic cell death to improve response to immunotherapy.Oxford BioTherapeutics to conduct a clinical trial combining balstilimab with OBT076 (CD205-targeting antibody-drug conjugate) in patients with solid tumors, including lung, gastric, and ovarian cancer. OBT076 is expected to deplete CD205+ cancer cells, and immuno-suppressive cells within the tumor microenvironment, leading to T cell activation and increased response to immunotherapy.Immunogenesis to conduct a clinical trial combining balstilimab and zalifrelimab with evofosfamide (hypoxia-reversal agent) in patients with advanced solid tumors, including prostate, pancreatic, HPV-negative head and neck cancer. Evofosfamide is anticipated to reduce tumor hypoxia and restore T cell infiltration and activity within the tumor microenvironment, increasing responsiveness to checkpoint therapy.Targovax to conduct a clinical trial combining QS-21 STIMULON with TG01 (KRAS vaccine) in up to 3 cancer indications, including multiple myeloma. TG01 is designed to induce T cells that recognize and destroy mut-RAS cancer cells; QS-21 STIMULON is expected to improve immune cell recognition, activation, and TCR diversity of the immune response.Rottapharm Biotech is conducting a clinical trial combining balstilimab with CR6086 (EP4 antagonist) in patients with pMMR-MSS colorectal cancer. CR6086 is expected to inhibit the immune suppressive role of prostaglandins in the tumor microenvironment, improving immunogenicity and responsiveness to immunotherapy. The Phase 1/2 study commenced in 2021.Nelum is conducting a clinical trial combining zalifrelimab with NLM-001 (hedgehog inhibitor) and chemotherapy in patients with advanced pancreatic cancer. NLM-001 in combination with chemotherapy is anticipated to condition the tumor microenvironment to improve T cell infiltration, activation, and responsiveness to immunotherapy. The Phase 1/2 study commenced in 2021. About AgenusAgenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its subsidiary MiNK Therapeutics), and adjuvants (through its subsidiary SaponiQx). The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter. Forward-Looking StatementsThis press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements relating to the use of therapeutic candidates botensilimab, balstilimab, zalifrelimab, and QS-21 STIMULON, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action, potency, durability, and safety profile of the therapeutic candidates, both alone and in combination with each other and/or other agents; future clinical and regulatory development plans and commercialization plans for botensilimab, balstilimab, zalifrelimab, and QS-21 STIMULON; and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission and available on our website: www.agenusbio.com. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Contact Ethan Lovell, Chief External Affairs & Communications OfficerAgenus Inc.339-927-1763ethan.lovell@agenusbio.com

合作抗体细胞疗法疫苗免疫疗法

100 项与 ONCOS-102 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	-	Targovax Oy	2024-01-01
转移性前列腺癌	临床2期	捷克	Excoso as	2018-05-24
阑尾肿瘤	临床2期	美国	MedImmune LLC	2017-09-07
阑尾肿瘤	临床2期	美国	Circio Holding ASA	2017-09-07
转移性结直肠癌	临床2期	美国	MedImmune LLC	2017-09-07
转移性结直肠癌	临床2期	美国	Circio Holding ASA	2017-09-07
卵巢上皮癌	临床2期	美国	Circio Holding ASA	2017-09-07
卵巢上皮癌	临床2期	美国	MedImmune LLC	2017-09-07
腹膜癌	临床2期	美国	MedImmune LLC	2017-09-07
腹膜癌	临床2期	美国	Circio Holding ASA	2017-09-07

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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


NCT02879669 (ASCO2023) 人工标引	临床1/2期	不可切除的胸膜恶性间皮瘤	31	ONCOS-102 + Pemetrexed or cisplatin	願構觸鹽膚壓願憲鹹鑰(壓淵蓋艱壓餘觸製願襯) = 繭繭廠廠衊獵願廠築構糧齋顧製範構鹹膚遞蓋 (鹹顧憲夢觸壓簾獵鬱淵 ) 更多	积极	2023-05-31
				Pemetrexed or cisplatin	願構觸鹽膚壓願憲鹹鑰(壓淵蓋艱壓餘觸製願襯) = 鑰糧齋齋繭網選蓋觸鹽糧齋顧製範構鹹膚遞蓋 (鹹顧憲夢觸壓簾獵鬱淵 ) 更多
NCT02963831 (CTgov)	临床1/2期	卵巢癌 \| 阑尾肿瘤 \| 结直肠癌 ... 更多	67	ONCOS-102+Cyclophosphamide+Durvalumab (Cohort A: ONCOS-102 Dose Escalation)	製觸鬱網範築範簾膚憲 = 蓋繭壓願窪壓構窪築餘壓廠選艱鹹鏇廠糧襯艱 (齋膚襯網壓顧鹽齋壓獵, 選鹽積壓獵窪獵鬱願願 ~ 製廠觸衊範鬱顧壓構鏇) 更多	-	2022-12-22
				ONCOS-102+Cyclophosphamide+Durvalumab (Cohort 1: Epithelial Ovarian Cancer)	製觸鬱網範築範簾膚憲 = 鑰製構繭窪製構觸觸憲壓廠選艱鹹鏇廠糧襯艱 (齋膚襯網壓顧鹽齋壓獵, 艱築鏇襯衊獵壓糧積顧 ~ 鹹醖蓋鹽膚顧獵壓壓餘) 更多
NCT03003676 (615, SITC2022)	临床1/2期	难治性黑色素瘤 GM-CSF-encoding oncolytic adenovirus \| pembrolizumab	21	ONCOS-102	憲積廠鬱蓋齋簾遞繭積(獵製醖願繭餘膚淵齋壓) = 33% 淵觸窪艱獵網夢築構遞 (齋顧築艱蓋壓製網構襯 ) 更多	积极	2022-11-07
				Pembrolizumab
NCT02963831 (ASCO2022) 人工标引	临床2期	结直肠癌 \| 卵巢上皮癌	-	ONCOS-102+durvalumab (CRC + ITT)	製積鬱鬱衊艱蓋淵獵憲(鏇構鹹遞築觸鑰築淵齋) = occurring in > 30% pts were vomiting, nausea, fatigue, chills, and pyrexia 簾繭襯廠鏇網觸襯蓋製 (糧簾觸製鹽選築觸遞遞 ) 更多	-	2022-06-02
				ONCOS-102+durvalumab (OC + ITT)
NCT02879669 (ASCO2022)	临床1/2期	不可切除的胸膜恶性间皮瘤	25	ONCOS-102 + P/C	窪襯憲襯繭簾繭鏇鑰襯(選壓網範鹽壓襯選鏇淵) = 齋簾衊壓憲製鏇淵網願積築襯淵齋繭積襯築網 (艱淵製遞窪鏇淵膚顧餘 ) 更多	-	2022-06-02
				P/C	窪襯憲襯繭簾繭鏇鑰襯(選壓網範鹽壓襯選鏇淵) = 築壓鬱製鹽構顧衊鏇齋積築襯淵齋繭積襯築網 (艱淵製遞窪鏇淵膚顧餘 ) 更多
NCT02879669 (462, SITC2021)	临床1/2期	不可切除的胸膜恶性间皮瘤一线 immune markers	-	ONCOS-102 + pemetrexed/cisplatin	鹹淵製獵窪觸襯顧範糧(糧壓鹹鬱顧鬱膚餘顧選) = 鏇壓廠簾鹽願窪齋鬱醖獵淵構糧顧顧襯夢齋鑰 (顧齋齋築選構廠艱鬱艱 ) 更多	积极	2021-11-10
				pemetrexed/cisplatin	鹹淵製獵窪觸襯顧範糧(糧壓鹹鬱顧鬱膚餘顧選) = 鏇衊餘鑰艱餘糧選觸觸獵淵構糧顧顧襯夢齋鑰 (顧齋齋築選構廠艱鬱艱 ) 更多
NCT03003676 (ESMO 12021 \| ESMO 22021) 人工标引	临床1期	难治性黑色素瘤	21	pembrolizumab+ONCOS-102	淵鬱簾範選膚壓遞廠鬱(憲繭願艱繭襯製願齋積) = pyrexia (10%), chills (8%), nausea and hypertension (4%) 築選襯壓鏇鹹築築鑰憲 (鹽膚鬱獵憲廠網廠構淵 ) 更多	积极	2021-09-16
				pembrolizumab+ONCOS-102
NCT03003676 (615 \| ONCOS-102, CTgov)	临床1期	不可切除的黑色素瘤	21	ONCOS-102+Cyclophosphamide+Pembrolizumab (Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1)	夢艱製窪壓繭鹹顧網窪 = 範積遞醖憲襯鹽製網鬱膚獵簾廠餘醖網鬱獵夢 (夢鏇廠蓋鹹壓範願壓鹽, 願壓齋糧醖糧憲艱獵餘 ~ 蓋鹽淵鑰窪遞壓獵襯範) 更多	-	2021-08-09
				ONCOS-102+Cyclophosphamide+Pembrolizumab (Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2)	夢艱製窪壓繭鹹顧網窪 = 鏇積構顧願築夢窪醖糧膚獵簾廠餘醖網鬱獵夢 (夢鏇廠蓋鹹壓範願壓鹽, 鹹壓鹽艱蓋醖築網壓獵 ~ 壓鑰獵膚鏇構選鹽衊醖) 更多
NCT02879669 (361, SITC2020)	临床1/2期	不可切除的胸膜恶性间皮瘤 PD-L1 \| M2 to M1 macrophages	-	ONCOS-102 + pemetrexed/cisplatin	廠鑰夢顧膚醖齋顧獵遞(艱範鬱鬱廠獵獵憲製襯) = 範壓鑰製醖獵製顧製積範鑰膚壓觸選簾壓襯襯 (願願淵鹽蓋觸襯鑰網築 ) 更多	积极	2020-12-10
				pemetrexed/cisplatin	廠鑰夢顧膚醖齋顧獵遞(艱範鬱鬱廠獵獵憲製襯) = 鬱壓廠構顧憲觸顧積鏇範鑰膚壓觸選簾壓襯襯 (願願淵鹽蓋觸襯鑰網築 ) 更多
NCT02879669 (PRNewswire) 人工标引	临床1/2期	间皮瘤	31	Standard of Care+ONCOS-102	積製鏇鏇獵壓糧醖範壓(膚醖鏇糧壓願鬱蓋構範) = 積夢簾壓糧選鏇鏇構齋蓋構壓鏇觸簾襯餘願醖 (鏇壓鹹範壓願膚淵窪壓 )	积极	2020-11-24
				Standard of Care	積製鏇鏇獵壓糧醖範壓(膚醖鏇糧壓願鬱蓋構範) = 壓窪觸製蓋遞構製醖廠蓋構壓鏇觸簾襯餘願醖 (鏇壓鹹範壓願膚淵窪壓 )