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更新于：2025-03-20

Trabedersen

更新于：2025-03-20

概要

概要

基本信息

药物类型

ASO

别名

TGF-beta antisense、Trabedersen (INN/BAN)

+ [6]

靶点

TGF-β2

作用方式

抑制剂

作用机制

TGF-β2抑制剂(转化生长因子β2抑制剂)

治疗领域

肿瘤神经系统疾病消化系统疾病+ [4]

在研适应症

胰腺癌转移性胰腺癌胰腺导管腺癌+ [5]

非在研适应症

结直肠癌新型冠状病毒感染多形性胶质母细胞瘤+ [5]

原研机构

Isarna Therapeutics GmbH

在研机构

Oncotelic Therapeutics, Inc.

Isarna Therapeutics GmbH

Oncotelic, Inc.

非在研机构

财团法人生物技术开发中心

Autotelic, Inc.

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评罕见儿科疾病 (美国)、孤儿药 (欧盟)

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结构/序列

使用我们的RNA技术数据为新药研发加速。

或

查看完整样例数据

Sequence Code 29532696

来源: *****

关联

项与 Trabedersen 相关的临床试验

NCT05425576

/ Not yet recruiting临床2期

Phase 2 Trial of TGF-β Inhibition (OT-101) With Anti-PD-1 (Pembrolizumab) in Patients With Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition

This is a study of OT-101, a TGF-b2 inhibitor in combination of pembrolizumab in patients with malignant pleural mesothelioma. Both efficacy assessment, and safety and tolerability of various dose of OT-101 in combination of pembrolizumab are evaluated.

开始日期2025-06-01

申办/合作机构

Oncotelic Therapeutics, Inc.

NCT06579196

/ Not yet recruiting临床1/2期IIT

Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1

The goal of this clinical trial is to: 1) evaluate the safety and recommended dose of the drug OT-101/Trabedersen when combined with Pembrolizumab and 2) determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer. The main question(s) it aims to answer are:
* What medical problems to participants have when taking OT101 together with Pembrolizumab?
* What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy?
* Does the combination therapy delay progression or relapse of the participant's Non-Small Cell Lung Cancer?
Participants will:
* Receive intravenous OT-101/Trabedersen for 4 days once every 2 weeks. Clinic visits are required to receive and disconnect the infusion.
* Receive intravenous Pembrolizumab once every 6 weeks.

开始日期2025-03-01

申办/合作机构

University of Nebraska

NCT06079346

/ Recruiting临床2/3期

A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer

The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.

开始日期2024-05-01

申办/合作机构

Oncotelic Therapeutics, Inc.

100 项与 Trabedersen 相关的临床结果

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100 项与 Trabedersen 相关的转化医学

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100 项与 Trabedersen 相关的专利（医药）

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项与 Trabedersen 相关的文献（医药）

2019-12-17·Current Pharmaceutical Design4区 · 医学

Therapeutic Potential of Targeting Transforming Growth Factor-beta in Colorectal Cancer: Rational and Progress

4区 · 医学

Review

作者: Khorrami, Shadi ; Ferns, Gordon A ; Kashani, Hoda ; Hassanian, Seyed M ; Avan, Amir ; Gachpazan, Meysam ; Khazaei, Majid

Background: Colorectal cancer (CRC) is one of the most common types of cancer and is associated with an increasing rate of mortality. Transforming Growth Factor-Beta (TGF-β) is often upregulated in CRC, and appears to play an important role in regulating cell proliferation, migration, immune surveillance, apoptosis, cell differentiation, drug-resistance and many cellular processes that may be involved in CRC, and therefore underscores its potential value as a therapeutic target in the treatment of CRC. An increased expression of the TGF- β pathway has been associated with poor prognosis in several cancer types, including CRC.Methods:Here, we describe the critical role of the TGF-β pathway in CRC as well as the preclinical and clinical investigations on TGF-β inhibitors, with particular emphasis on recent findings with small-molecule inhibitors in CRC. Several TGF-β inhibitors (e.g., Trabedersen, Galunisertib, Gradalis, PF-03446962, NIS793) have been generated over the past decade for targeting this pathway.Results:There is accumulating evidence of the therapeutic potential of this and other TGF-β inhibitors for the treatment of other malignancies. These inhibitors might be used in combination with chemotherapy as well as with other biological agents, in order to overcome different resistance mechanisms. However, further studies are needed to identify determinants of the activity of TGF-β inhibitors, through the analysis of genetic and environmental alterations affecting TGF-β and parallel pro-cancer pathways.Conclusion: These studies will be critical to improving the efficacy and selectivity of current and future anticancer strategies targeting TGF-β.

2019-01-01·Journal of Controlled Release1区 · 医学

Pharmacokinetic evaluation of liposomal nanoparticle-encapsulated nucleic acid drug: A combined study of dynamic PET imaging and LC/MS/MS analysis

1区 · 医学

Article

作者: Enokizono, Junichi ; Wada, Yasuhiro ; Iwano, Junko ; Yabuuchi, Hayato ; Warashina, Shota ; Zouda, Maki ; Yagi, Nobuhiro ; Watanabe, Yasuyoshi ; Narushima, Kazuya ; Mukai, Hidefumi ; Hatanaka, Kentaro ; Takahashi, Maiko ; Kuboyama, Takeshi

In vivo biodistribution analyses, especially in tumors, of nucleic acids delivered with nanoparticles are important to develop drug delivery technologies for medical use. We previously developed wrapsome® (WS), an ~100 nm liposomal nanoparticle that can encapsulate siRNA, and reported that WS accumulates in tumors in vivo and inhibits their growth by an enhanced permeability and retention effect. In the present study, we evaluated the pharmacokinetics of nucleic acid-containing nanoparticles by combining dynamic positron emission tomography (PET) imaging and liquid chromatography-tandem mass spectrometry (LC/MS/MS) analysis. An 18-mer phosphorothioate oligodeoxynucleotide (ODN), trabedersen, was used as a model drug and was encapsulated in WS. Dynamic PET imaging and time-activity curve analysis of WS-encapsulated ⁶⁴Cu-labeled ODNs administered to mice with MIA PaCa-2 subcutaneous xenograft tumors showed tumor accumulation (~3% injected dose per gram (%ID/g)) and liver accumulation (~30 %ID/g) at 24 h. Under these conditions, LC/MS/MS analysis showed that the level of intact ODNs was 1.62 %ID/g in the tumor and 1.70 %ID/g in the liver. From these pharmacokinetic data, the intact/accumulated ODN ratios were calculated using the following equation: intact/accumulated ODN ratio (%) = %ID/g _{LC/MS/MS, tissue, mean}/%ID/g _{PET, tissue, mean} × 100. Interestingly, the ratios for the tumor and kidney were maintained at 20-50% over 48 h after administration of the WS-encapsulated form. In contrast, the ratio for the liver rapidly decreased at 24 h, showing the same pattern as that for naked ODN. These different patterns indicate that WS effectively protected the ODN in the tumor and kidney, but protected it less efficiently in the liver. A combined approach of dynamic PET imaging and LC/MS/MS analysis will assist the development of nanoparticle-encapsulated nucleic acid drugs, such as those using WSs, to determine their detailed pharmacokinetics.

2014-02-01·Bioanalysis4区 · 医学

Quantification of Oligonucleotides by LC–MS/MS: The Challenges of Quantifying A Phosphorothioate Oligonucleotide and Multiple Metabolites

4区 · 医学

Article

作者: Ewles, Matthew ; Goodwin, Lee ; Rothhammer-Hampl, Tanja ; Schneider, Anneliese

Background: LC–MS/MS allows quantification of therapeutic oligonucleotides in biological fluids at low ng/ml concentrations. Achieving selectivity between metabolites and parent molecules in a single assay is one of the biggest challenges when developing a method. We present a strategy that allows quantification of an 18-mer antisense therapeutic, trabedersen, and six metabolites in human plasma. Results/Methodology: The method utilizes phenol-chloroform and SPE with UHPLC–MS/MS to independently quantify trabedersen and the 5´n-1, 5´n-2, 5´n-3, 3´n-1, 3´n-2 and 3´n-3 metabolites in a single assay. The qualification data indicate that if the method was validated it would meet regulatory expectations for precision, accuracy and selectivity. Conclusion: We show that quantification of an oligonucleotide and multiple metabolites, including isobaric 3´ and 5´ metabolites, is achievable in a single assay through good sample clean-up and careful optimization of the LC–MS/MS parameters. The strategy presented here can be applied elsewhere and may be useful for other oligonucleotides and their metabolites.

项与 Trabedersen 相关的新闻（医药）

2025-02-26

·美迪西Medicilon

Oncotelic与美迪西在核酸药物、纳米制剂等领域达成战略合作

Swipe left for English 2月25日，全球领先的RNA疗法制药企业Oncotelic Therapeutics（OTCQB: OTLC）及其合资公司GMP生物技术有限公司全资子公司Sapu Bioscience, LLC（Oncotelic持有45%股份），与上海美迪西生物医药股份有限公司（股票代码：688202.SH）宣布达成战略合作。此次合作旨在通过美迪西一站式生物医药临床前综合研发服务平台，5年加速推进Oncotelic和SAPU20件新药临床试验申请（IND）项目，目前多个新型抗癌药物IND项目正在积极推进中。 ✦ Oncotelic：全球领先的RNA疗法制药企业 ✦ Oncotelic在肿瘤药物开发领域已深耕37年，专注于RNA疗法与小分子药物的研发创新，尤其在罕见儿科癌症领域取得了丰硕的研究成果。通过合资企业形式，Oncotelic获得多项罕见病疗法认定，包括针对DIPG的OT-101、针对黑色素瘤的CA4P及针对AML的OXi 4503。此后，Oncotelic收购PointR Data Inc.，转型为AI驱动的生物制药公司；获AL-101开发权，计划用于治疗帕金森病、勃起功能障碍等，不断拓展其研发管线与治疗领域。 ✦ 美迪西：全球新药临床前研发服务赋能者 ✦ 美迪西，作为中国少有的一站式生物医药临床前研发服务平台，始终站在国际技术前沿，成功搭建了涵盖ADC、核酸、PROTAC、抗体、多肽、疫苗以及细胞与基因治疗等多个领域的新分子药物研发服务平台。截至2024年底，美迪西已助力约520件IND项目获批临床、60件IND项目实现中美双报获批，积累了丰富的中美欧多国申报的成功经验。聚焦核酸药物、纳米制剂等领域美迪西助力Oncotelic5年推进20个IND项目此次合作不仅是Oncotelic和SAPU在新型癌症疗法领域前瞻战略布局与深度研发信念的深刻体现，也是各方创新愿景高度契合、优势资源深度整合的典范。根据战略协议，美迪西将依托一站式生物医药临床前综合研发服务平台，为Oncotelic和SAPU提供包括药物发现、药学研究（原料药、制剂）、临床前研究（药效、药代、安评）等在内的一站式临床前研发支持，5年助力Oncotelic和SAPU加速推进20个新药项目的IND申报，涵盖核酸药物和纳米制剂等创新药物，为全球新药研发注入崭新的活力与创新动力。 Vuong Trieu 博士 Oncotelic和SAPU董事长&CEO “此次合作将为我们的开发项目带来革命性的变革。美迪西一站式生物医药临床前综合研发服务平台对于加速SAPU和Oncotelic药物研发进程至关重要。我们期待与美迪西继续深化合作，携手推动创新抗癌药物更快进入临床阶段。” 陈春麟博士美迪西创始人、董事长&CEO “非常荣幸能够与Oncotelic和SAPU达成战略合作。我们将依托在新药研发领域所积累的研发技术和国际经验，为Oncotelic和SAPU提供一站式临床前研发服务，携手并进，共同加速新药研发的进程，为全球病患开辟新的治疗选择。” 关于Oncotelic Oncotelic Therapeutics（前身为Mateon Therapeutics, Inc.）最初于1988年在纽约州成立，名为OXiGENE, Inc.，1992年重新在特拉华州注册，2016年更名为Mateon Therapeutics, Inc.，并于2020年11月更名为Oncotelic Therapeutics, Inc.。公司致力于利用其在肿瘤药物开发领域的深厚专长，以改善癌症患者（尤其是罕见儿科癌症）的治疗效果和生存率。通过旗下持有45%股权的合资企业GMP Biotechnology Limited，Oncotelic已获得多项罕见儿科疾病认定：针对弥漫性内生型桥脑胶质瘤（DIPG）的OT-101疗法、针对黑色素瘤的CA4P疗法，以及针对急性髓系白血病（AML）的OXi 4503疗法。2019年11月，Oncotelic收购了PointR Data Inc.，旨在打造一家由人工智能驱动的生物科技公司。此外，公司于2021年第四季度获得了AL-101（用于鼻内递送阿扑吗啡）的开发权，计划将其应用于帕金森病、勃起功能障碍、女性性功能障碍及性欲减退症的治疗。这些疾病均影响着庞大患者群体，存在迫切的临床需求。有关AL-101的详细信息，请参阅公司于2024年4月12日向美国证券交易委员会（SEC）提交的2023年度10-K表格报告。关于美迪西美迪西（股票代码：688202.SH）成立于2004年，总部位于上海，致力于为全球制药企业、研究机构及科研工作者提供全方位的临床前新药研究服务。美迪西的一站式综合服务以强有力的项目管理和更高效、高性价比的研发服务助力客户加速新药研发进程，服务涵盖医药临床前新药研究的全过程，包括药物发现、药学研究及临床前研究。至2024年底，美迪西已为全球超2000家客户提供药物研发服务，参与研发完成的新药及仿制药项目已有约520件IND获批临床，与国内外优质客户共同成长。美迪西将继续立足全球视野，聚力中国创新，为人类健康贡献力量！右滑查看中文版 AGOURA HILLS, Calif., February 25, 2025– Oncotelic Therapeutics, Inc. (OTCQB:OTLC). Oncotelic Therapeutics Inc., a leader in RNA-based therapeutics, including its subsidiaries (“Oncotelic”) and including Sapu Bioscience, LLC (“SAPU”), a wholly owned subsidiary of GMP Biotechnology Limited in which Oncotelic is a 45% owner, is pleased to announce a strategic partnership with Shanghai Medicilon Inc. (“Medicilon”) (stock code: 688202.SH). Through this collaboration, Oncotelic and SAPU will utilize Medicilon’s industry-leading rapid IND development platform to support up to 20 Investigational New Drug (IND) projects. Six of these INDs are ongoing and are focused on next-generation anticancer agents. Oncotelic and SAPU's partnership with Medicilon is poised to significantly accelerate the development of our innovative oncology pipeline. This collaboration reflects our strategic move to strengthen our position as a leader in novel cancer therapies. Enabling Rapid Growth: Medicilon’s integrated platform for drug discovery, pharmaceutical research, and preclinical development will expedite the regulatory pathways for Oncotelic’s and SAPU’s upcoming IND submissions. Portfolio Expansion: This initiative will initially focus on the current six INDs but has the potential to extend up to 20 projects, reflecting the depth of Oncotelic’s and its affiliates’ R&D programs. Dr. Vuong Trieu Chairman and CEO of Oncotelic and SAPU “This partnership is poised to be a game-changer for our development programs. The ability to access a rapid IND-enabling platform is crucial for accelerating SAPU’s and Oncotelic’s development programs. We look forward to continued success working with Medicilon as we advance innovative anticancer agents to the clinic.” Dr. Chen Chunlin Chairman,Founder and CEO of Medicilon “We are excited to partner with Oncotelic and SAPU and contribute our international experience in drug R&D. We are a comprehensive, one-stop services organization, from early discovery to IND registration, built to accelerate the translation of Oncotelic and SAPU’s pipeline into new therapeutic options for patients.” About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (“AML” through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our 2023 Annual Report on form 10-K filed with the SEC on April 12, 2024. About Medicilon From its inception in 2004, Shanghai Medicilon Inc. (stock code: 688202.SH) has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. By the end of 2024, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 520 new drugs and generic drug projects that have been approved for clinical trials with IND applications.

抗体药物偶联物临床申请并购核酸药物

2024-11-09

·药渡

肿瘤微环境中的免疫抑制性细胞因子

来源：小药说药前言癌细胞表观遗传学和生长动力学的改变导致细胞外分泌多种细胞因子，这些细胞因子控制免疫细胞的活性，使其有利于肿瘤生长。其中，免疫调节细胞因子的分泌是招募免疫抑制细胞的主要因素。肿瘤微环境中的免疫调节细胞因子招募其他免疫抑制细胞，并负责效应免疫细胞的表型和功能转换，使其支持肿瘤的发展。表型转换的免疫细胞进一步提高免疫抑制细胞因子的水平，并使肿瘤环境抵抗抗肿瘤免疫细胞的活性。其中MDSCs、TAMs、Treg和Breg细胞是调节性细胞因子的主要来源。在广泛的免疫抑制细胞因子中，IL-10、TGF-β、IL-4和IL-35在多种癌症的肿瘤环境中占主导地位，主要负责免疫抑制。这些细胞因子改变先天性和适应性免疫细胞的命运，并调节癌细胞的生长和增殖能力。同时，免疫抑制细胞因子也改变了幼稚免疫细胞的表观基因组和转录网络，有利于免疫抑制细胞谱系的形成。此外，这些细胞因子可以直接作用于细胞毒性CD8+T细胞或自然杀伤（NK）细胞，并抑制其效应器功能和增殖。 IL-10 IL-10是一种多功能的免疫抑制细胞因子，具有免疫调节和血管生成功能。IL-10由癌细胞和几种免疫细胞分泌，包括髓系和淋巴细胞。已有证据表明IL-10具有促进肿瘤和抑制肿瘤的双重功能。一方面，IL-10通过下调癌细胞和APC上的MHC表达来抑制细胞毒性T细胞活化，从而阻止抗原特异性T细胞识别癌细胞。另一方面，高剂量的IL-10可增强CD8+T细胞的增殖及其细胞毒性活性。某些炎性细胞因子和条件可能会促进组织损伤和肿瘤发生，IL-10可以抑制这些炎症状态，从而防止随后的肿瘤发生。最近的研究表明，基于西妥昔单抗的IL-10融合蛋白（CmAb-IL10）通过阻止树突状细胞介导的肿瘤浸润性CD8+T细胞凋亡，显示出强大的抗肿瘤作用。CmAb-IL10与免疫检查点阻断剂的联合应用显示，晚期肿瘤小鼠的抗肿瘤免疫力得到明显改善。因此，有必要根据具体癌症类型和患者亚群的具体情况，通过抑制或促进IL-10通路来评估潜在的治疗干预。 TGF-β TGF-β作为一种免疫抑制细胞因子，通过不同的机制对免疫应答产生广泛的抑制作用。TGF-β降低Th1、Th2细胞和细胞毒性T淋巴细胞（CTL）的分化和功能，所有这些都提供重要的抗肿瘤反应。此外，TGF-β还通过调节Treg细胞的数量和功能，增强免疫耐受和肿瘤逃避。TGF-β通过抑制或刺激细胞增殖来调节免疫细胞的命运，从而影响胸腺和外周T细胞的发育。 TGF-β在TME中起着双重作用，这是由于肿瘤发展的不同阶段和基因改变背景决定的。在早期肿瘤中，TGF-β途径可诱导细胞凋亡并抑制包括癌细胞在内的细胞增殖。矛盾的是，在晚期，它通过调节基因组不稳定性、EMT、新生血管生成、免疫逃避和转移，具有促肿瘤作用。当促肿瘤功能压倒细胞中TGF-β信号的抗肿瘤作用时，它将以一致的方式作为肿瘤促进剂发挥作用。尽管有许多因素增加了TGF-β信号转导的复杂性，但在肿瘤治疗中TGF-β信号靶向药物显示出了强大的活性。这些特异性或非特异性药物包括靶向TGF-β受体的小分子、反义寡核苷酸、疫苗、中和抗体以及受体IgG-Fc融合蛋白。 Galunsertib（LY2157299）是第一个进入临床试验的小分子阻断剂，它抑制TGF-βRI激酶。在一项1/2期临床试验中，与安慰剂吉西他滨相比，Galunisertib联合吉西他滨治疗PAC患者的OS明显改善。TEW-7197是另一种TGF-βRI激酶抑制剂。 GC-1008（fresolimumab）是一种能中和TGF-β所有亚型的人源单克隆抗体。M7824（Bintrafusp-alfa）是一种由抗PD-L1的抗体和TGF-βRII分子的胞外段组成的双功能分子，可以“捕获”在TME中的TGF-β。ABBV-151影响TGF-β主动释放的复杂过程是另一种治疗干预手段。抗GARP抗体ABBV-151阻断其与LAP的结合显著减缓乳腺癌细胞系的肺转移。 Belagenpumatucel-L（Lucanix）是一种治疗性、基因修饰的异基因肿瘤细胞疫苗，用于NSCLC，抑制TGF-β2 mRNA的产生。虽然针对NSCLC的3期试验没有达到预定的临床终点，但额外的分析表明在患者亚群中取得了令人鼓舞的结果，在一线化疗结束后12周内随机使用Lucanix治疗的患者中，观察到OS的显著增加。Trabedersen（ap12009）是TGF-β2基因mRNA区域的反义互补物，通过下调TGF-β2 mRNA发挥抑制作用。在一项2期研究中，与标准化疗治疗相比，使用10 mM trabedersen治疗的复发/难治性晚期胶质瘤患者的2年生存率更高。 IL-4 IL-4主要作用于Th2细胞的谱系特异性分化和体液免疫反应的调节。除嗜碱性粒细胞和肥大细胞外，IL-4主要由Th2细胞通过自分泌信号分泌。IL-4在肿瘤微环境中发挥着多种作用，并具有免疫抑制和抗肿瘤活性。研究表明，在结肠癌和乳腺癌小鼠模型中，阻断IL-4可减少特定肿瘤微环境中免疫抑制M2表型和MDSCs的生成，并改善肿瘤特异性CD8+T细胞反应。此外，阻断IL-4可提高抗OX40免疫治疗的反应性。在非小细胞肺癌小鼠模型中进行的类似研究表明，阻断IL-4可通过肿瘤抗原特异性树突状细胞增加IL-12的生成，从而增强效应T细胞的浸润和增殖，并减轻肿瘤负担。此外，在间变性甲状腺癌（ATC）小鼠模型中，IL-4的缺失可增强抗肿瘤免疫和总体存活率，且无任何明显毒性。研究表明，IL-4是一个新的治疗靶点，阻断可以减少肿瘤诱导的免疫抑制，提高传统癌症治疗的疗效。因此，与其他免疫抑制性细胞因子类似，IL-4是肿瘤发生和转移的关键调节因子，可能单独或与当前有效治疗癌症患者的治疗方案相结合，是一个有吸引力的免疫治疗靶点。 IL-35 与IL-10、TGF-β和IL-4相比，IL-35是一种异二聚体且相对较新发现的细胞因子，属于IL-12家族细胞因子，由p35和EBi3亚单位组成。IL-35已被证明在良性和恶性肿瘤的发展中发挥重要作用，包括肝细胞癌、晚期乳腺癌、胰腺导管腺癌、非小细胞肺癌和前列腺癌。此前，已有研究证明IL-35主要由Tregs产生，近年来，肿瘤细胞中IL-35的表达逐渐得到证实。在体内，IL-35通过增强其他细胞因子的分泌，如IL-6和G-CSF（粒细胞集落刺激因子），促进肿瘤生长、进展和转移。IL-35还抑制多种细胞因子，包括IFN-γ，以实现促肿瘤效应。积累的数据表明，IL-35可以参与TME中恶性肿瘤细胞与周围免疫细胞之间的相互作用，诱导免疫抑制环境并限制有效抗肿瘤免疫反应的参与。随着多种IL-35+免疫细胞类型如M1 TAM和DC的发现和分离，目前的证据表明，肿瘤源性IL-35广泛参与不同细胞环境的促肿瘤特性，可能是通过抑制肿瘤浸润淋巴细胞（TIL）浸润和效应细胞增殖。总的来说，恶性肿瘤细胞以及周围基质细胞产生的IL-35有助于肿瘤微环境内的免疫抑制，从而支持肿瘤的持续生长和转移小结细胞因子在决定肿瘤发生命运的肿瘤免疫微环境中起着至关重要的作用。这些免疫抑制细胞因子限制抗肿瘤免疫细胞的增殖和效应功能，改变其可塑性，并将其转化为抑制表型。由于受限制的渗透或缺乏效应免疫细胞，导致免疫检查点抑制剂无法发挥最佳效果。因此，靶向或消耗这些细胞因子具有显著的临床益处。几种细胞因子在肿瘤发生中发挥免疫抑制作用，具体取决于肿瘤类型和肿瘤免疫环境。最近的多项研究显示，IL-10、TGF-β、IL-4和IL-35，这些细胞因子在限制抗肿瘤免疫和肿瘤生长进展中发挥重要作用。阻断IL-10、TGF-β、IL-4和IL-35等免疫抑制性细胞因子可能在使肿瘤对常规和免疫疗法敏感方面发挥显著的效果，从而激活抗肿瘤免疫，并控制肿瘤发生。参考文献： 1.Tumorpromoting roles of IL-10, TGF-β, IL-4, and IL-35: Its implications in cancerimmunotherapy. SAGE Open Med. 2022; 10: 20503121211069012. 2. Roles ofTGF-β signaling pathway in tumor microenvirionment andcancer therapy. Int Immunopharmacol. 2020 Oct 21;89(Pt B):107101. 3. IL-35 Regulatesthe Function of Immune Cells in Tumor Microenvironment. Front Immunol. 2021;12: 683332. 药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

免疫疗法

2024-11-06

·GlobeNewswire-Health Care

ONCOTELIC CLINICAL PRESENTATIONS AT SITC 2024

AGOURA HILLS, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) announced today its presentation at SITC 2024. Dr. Cynthia Lee, VP of R&D will be presenting Sapu Bio pipeline of TGFB2 therapeutics. For additional information please go to: https://www.sitcancer.org/home. Dr. Lee has been leading our R&D programs for the past several years including the buildout of our GMP facility in San Diego. The presentations are: Abstract Number 198: TGFB2 mRNA levels prognostically interact with Interferon-alpha receptor activation of IRF9 and IFI27, and makers for tumor-associated macrophages impacting overall survival in PDAC. Authors Sanjive Qazi, Cynthia Lee, Vuong Trieu Abstract Number 218: Evaluating the prognostic impact of Transforming growth factor beta 2 mRNA levels, in conjunction with Interferon-gamma receptor activation of IRF5 and expression of CD276/B7-H3 in low-grade gliomas. Authors Sanjive Qazi, Anthony Maida, Vuong Trieu Abstract Number 1444: Meta-analysis comparing the incidence of serious adverse events, overall survival, and progression-free survival in PDAC patients harboring unresectable tumors treated with mFOLFIRINOX or FOLFIRINOX. Authors Vuong Trieu, Sanjive Qazi, Seymour Fein, Anthony Maida, Tenshang Joh About Oncotelic Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (through OXi 4503). Oncotelic acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. Oncotelic’s first in class TGFB2 therapeutic to treat pancreatic cancer and glioblastoma is being developed through its JV – Sapu Bio. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the Company’s product candidates and the potential use of the Company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform, the development of the Company’s AI suite including but not limited to AI Chatbots, the public access to the Company’s AI suite, the success of the development of the AI suite or any other AI technologies and whether if any or portion thereof the Company’s AI suite or technologies will be commercialized and launched for sale. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's Annual Report on Form 10-K/A filed with the SEC on April 19, 2023 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether because of new information, future events, or otherwise. Contact Information: For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com

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100 项与 Trabedersen 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
胰腺癌	临床3期	-	Isarna Therapeutics GmbH	-
多形性胶质母细胞瘤	临床申请	德国	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床申请	中国台湾	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床申请	英国	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床申请	法国	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床前	俄罗斯	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床前	德国	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床前	法国	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床前	中国台湾	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床前	英国	Isarna Therapeutics GmbH	2008-12-01

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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


NCT04801017 (C001, Corporate Publications) 人工标引	临床2期	新型冠状病毒感染	32	Standard of Care+OT-101	鏇鬱鏇築鏇蓋襯繭顧願(膚願簾繭膚鏇繭廠糧鹹) = 夢蓋壓鹹餘繭鏇鬱餘艱蓋選構廠艱遞簾齋網窪 (製艱餘築選壓窪醖範衊 ) 更多	积极	2021-11-23
NCT04801017 (C001, Corporate Publications) 人工标引	临床2期	新型冠状病毒感染	32	Standard of Care+Placebo	鏇鬱鏇築鏇蓋襯繭顧願(膚願簾繭膚鏇繭廠糧鹹) = 網選積鏇積築廠願顧醖蓋選構廠艱遞簾齋網窪 (製艱餘築選壓窪醖範衊 ) 更多	积极	2021-11-23
NCT00431561 (ATIM-03, SNO2019)	临床2期	星形细胞瘤 TGF-ß2	77	OT-101	(積鑰選鹹網膚範餘積壓) = 獵鬱網襯艱繭構簾窪廠觸夢糧壓蓋淵網鹽鑰築 (鑰鹹鹽糧鹹鹹構襯範選 ) 更多	积极	2019-11-11
NCT00431561 (ATIM-06, SNO2019)	临床2期	多形性胶质母细胞瘤 \| 胶质母细胞瘤 \| 复发性胶质瘤 \| 复发性恶性胶质瘤	26	OT-101	糧鏇簾憲淵憲範艱壓遞(積襯蓋衊遞積選鏇膚積) = 選範網鹹蓋鹹蓋餘選蓋醖網蓋醖膚繭簾範壓顧 (遞製衊構齋網鹹鹽襯繭 ) 更多	积极	2019-11-11
NCT00431561 (ATIM-06, SNO2019)	临床2期	多形性胶质母细胞瘤 \| 胶质母细胞瘤 \| 复发性胶质瘤 \| 复发性恶性胶质瘤	26	Temozolomide (TMZ)	糧鏇簾憲淵憲範艱壓遞(積襯蓋衊遞積選鏇膚積) = 膚遞觸顧糧鏇積餘廠選醖網蓋醖膚繭簾範壓顧 (遞製衊構齋網鹹鹽襯繭 ) 更多	积极	2019-11-11
NCT00844064 (ASCO2017)	临床2期	黑色素瘤 \| 结直肠癌 \| 胰腺癌二线	37	OT-101	(膚繭衊淵願鹹鏇鹹蓋獵) = 膚衊糧觸鬱醖繭獵願遞繭餘遞蓋鹽鏇淵壓糧糧 (窪艱網膚壓齋遞餘觸築 )	积极	2017-05-30
P-001 (AACR2016)	N/A	晚期胰腺腺癌三线	37	Trabedersen	(鹹網網鏇鹽膚餘觸築窪) = 築廠餘齋糧構膚艱鑰觸鹹獵鬱糧簾構窪憲顧鏇 (範夢鏇顧膚艱糧製鹽餘 ) 更多	积极	2016-07-15
P-001 (AACR2016)	N/A	晚期胰腺腺癌三线	37	Chemotherapy	(齋積膚簾淵觸糧艱鹽壓) = 鑰齋製簾鏇遞製廠築醖鏇鑰夢遞鏇淵襯淵範繭 (鏇壓鹽廠顧鹽夢觸壓構 )	积极	2016-07-15
NCT00844064 (OT-101, ASCO2016)	临床1期	黑色素瘤 \| 结直肠癌 \| 胰腺癌	37	Trabedersen (OT-101)	(窪糧膚淵窪鏇網顧襯遞) = 窪遞夢鹹夢遞膚繭壓艱襯蓋壓範製製淵襯觸糧 (選壓築淵遞簾選餘鏇願 )	积极	2016-05-20
NCT00761280 (SAPPHIRE, CTgov)	临床3期	多形性胶质母细胞瘤 \| 胶质母细胞瘤	27	Drug delivery system for administration of AP 12009+trabedersen (Trabedersen 10 µM)	築顧淵艱鬱選鹽鑰蓋餘(獵積齋鬱繭壓範廠範積) = 簾積蓋膚積積顧鏇衊獵構襯繭醖淵鏇製鹽淵憲 (襯鹽鏇廠網醖選憲鹽鏇, 鹽鏇製衊繭艱齋製遞艱 ~ 鬱選網蓋艱積願構糧製) 更多	-	2014-08-22
NCT00761280 (SAPPHIRE, CTgov)	临床3期	多形性胶质母细胞瘤 \| 胶质母细胞瘤	27	temozolomide+lomustine+carmustine (Chemotherapy)	築顧淵艱鬱選鹽鑰蓋餘(獵積齋鬱繭壓範廠範積) = 壓衊夢醖醖選遞簾製繭構襯繭醖淵鏇製鹽淵憲 (襯鹽鏇廠網醖選憲鹽鏇, 選網醖糧壓構膚淵鬱構 ~ 鏇蓋襯構壓範鬱繭製鏇) 更多	-	2014-08-22
ASCO2012	临床1/2期	黑色素瘤 \| 结直肠癌 \| 胰腺癌	61	Trabedersen	(構構願鑰壓簾鹽範憲遞) = 積壓糧構獵膚膚鬱鬱製獵膚餘鏇鏇觸鬱繭觸觸 (鹹窪齋壓鏇鑰淵襯壓壓 ) 更多	-	2012-05-20
ASCO2011	临床1/2期	黑色素瘤 \| 结直肠癌 \| 胰腺癌	33	Trabedersen	廠夢蓋製艱鏇選選獵壓(餘鹽壓鏇膚淵繭餘鬱鬱) = 網蓋積醖壓糧範襯窪築糧鬱獵窪糧選鹽範觸構 (範鑰夢膚構襯衊廠鹽製 )	-	2011-05-20
AACR2011	临床1/2期	肿瘤	33	Trabedersen	(襯壓遞蓋構範鹹願壓構) = 繭遞遞顧網餘製夢網繭蓋遞夢壓製廠壓齋壓襯 (顧蓋獵鏇鹹築鑰範繭繭 )	-	2011-04-15