An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan/5-FU/Leucovorin or Gemcitabine/Nab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients

The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints.

开始日期2026-01-01

申办/合作机构

TME Pharma NV

[+1]

NCT04121455

/ Active, not recruiting临床1/2期

Single-arm, Dose-escalation Phase 1/2 Study of Olaptesed Pegol (NOX-A12) in Combination With Irradiation in Inoperable or Partially Resected First-line Glioblastoma Patients With Unmethylated MGMT Promoter With a Multiple-arm Expansion Group

The purpose of this study is to obtain first, exploratory information on the safety and efficacy of (i) olaptesed pegol in combination with radiation therapy in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection (biopsy only) or after incomplete tumor resection, and (ii) olaptesed pegol in combination with radiation therapy and bevacizumab in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection (biopsy only) or after incomplete or complete tumor resection.
Further arms are included (i) to establish safety for the combination of olaptesed pegol at three different doses in addition to radiotherapy and bevacizumab, (ii) to explore the benefit of combining olaptesed pegol at different dose levels with bevacizumab in order to define the doses to move forward into a subsequent randomized dose-finding study, (iii) to explore the contribution of the therapy components olaptesed pegol and bevacizumab to patient benefit and (iv) to put the clinical outcome of these treatment regimens into perspective with the standard of care treatment with temozolomide and radiotherapy.

开始日期2019-09-12

申办/合作机构

TME Pharma NV

NCT03168139

/ Completed临床1/2期

A Two-part, Open-label Phase 1/2 Study to Evaluate Pharmacodynamic Effects and Safety of Olaptesed Pegol Monotherapy and Safety and Efficacy of Olaptesed Pegol / Pembrolizumab Combination Therapy in Metastatic Colorectal and Pancreatic Cancer

The purpose of this study is to show that the type, number and/or distribution of tumor metastases infiltrating immune cells such as cytotoxic T cells and/or the cytokine signature in the tumor metastases can be modulated by treatment with olaptesed pegol and to explore safety, tolerability and efficacy of olaptesed pegol in combination with pembrolizumab as a basis for subsequent studies in combination with immunotherapies, in particular checkpoint inhibitors.

开始日期2017-04-18

申办/合作机构

TME Pharma NV

[+1]

100 项与 Olaptesed Pegol 相关的临床结果

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100 项与 Olaptesed Pegol 相关的转化医学

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100 项与 Olaptesed Pegol 相关的专利（医药）

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项与 Olaptesed Pegol 相关的文献（医药）

2025-12-30·Zhurnal voprosy neirokhirurgii imeni N. N. Burdenko

Aptamer-based conjugated molecules in experimental and clinical approaches to treatment of glioblastoma

Review

作者: Usachev, D.Yu. ; Kobyakov, G.L. ; Bezbabicheva, T.S. ; Pavlova, G.V. ; Kopylov, A.M.

Glioblastoma is the most common primary malignant tumor of nervous system and one of the most incurable human tumors. The median of overall survival is 16—17 months after comprehensive treatment. Among various difficulties for new therapeutic approaches, we should emphasize the blood-brain barrier complicating delivery of anti-cancer drugs to neoplasm and perifocal area. A promising approach is aptamer molecules as synthetic amino acid analogs capable of interacting and regulating activity of target proteins based on their spatial structural interactions. Aptamers possess high specificity and affinity to various receptors on cell surface and inside its structures if they penetrate cell membrane. In this review, we present various approaches to development of aptamer-based drugs against glioblastoma. Kopylov A.M. et al. synthesized a series of aptamers targeting EGFR and capable for delivery of toxic agents to tumor cells. Important clinical successes include the results of NOX-A12 drug and data on combined drugs based on trastuzumab in patients with metastatic breast cancer. NOX-A12 is an aptamer blocking CXCL-12 gene and reducing resistance to irradiation of glioblastoma cells. Furthermore, very high control of breast cancer brain metastases in HER-2 positive cases was demonstrated for trastuzumab-emtansine and trastuzumab-deruxtecan. The last finding indicates the perspective for aptamer targeting glioblastoma tumor cells in conjugation with emtansine or deruxtecan.

2022-04-01·European journal of pharmacology3区 · 医学

The contributory roles of the CXCL12/CXCR4/CXCR7 axis in normal and malignant hematopoiesis: A possible therapeutic target in hematologic malignancies

3区 · 医学

Review

作者: Mehrpouri, Mahdieh

C-X-C motif chemokine 12 (CXCL12), also known as stromal cell-derived factor-1 (SDF-1), is produced by the bone marrow microenvironment. This chemokine binds and activates its cognate receptors C-X-C chemokine receptor type 4 (CXCR4) and C-X-C chemokine receptor type 7 (CXCR7) to widely regulate cell proliferation, survival, differentiation, as well as homing and mobilization of hematopoietic stem cells (HSCs) in specialized niches within the bone marrow. Given this key role in hematopoiesis, it comes as no surprise that any aberrancies in CXCL12/CXCR4 or CXCL12/CXCR7 pathways might lead to excessive proliferation of HSCs, an event that leads to the development of leukemia. So far, numerous therapeutic interventions have been developed to harness CXCL12/CXCR4 and CXCL12/CXCR7 axes in leukemic cells. Plerixafor, BKT140, LY2510924, PF-06747143, ulocuplumab, and NOX-A12 are among the most well-known CXCR4 and CXCL12 modulators that their therapeutic efficacies have been evaluated in different pre-clinical and clinical studies of hematologic malignancies. To have an overview of the importance of CXCL12/CXCR4 and CXCL12/CXCR7 axes in the pathogenesis of leukemia and to gather information about the latest advances as well as challenges in targeting these axes in clinical settings, the present review has begun with a discussion about how aberrant expression of CXCL12/CXCR4 and CXCL12/CXCR7 pathways might regulate leukemogenesis and ended by outlining the key news of preclinical and clinical investigations in leukemia treatment.

2021-10-01·Journal for immunotherapy of cancer2区 · 医学

Combined inhibition of CXCL12 and PD-1 in MSS colorectal and pancreatic cancer: modulation of the microenvironment and clinical effects

2区 · 医学

ArticleOA

作者: Jutta Schreiber ; Niels Halama ; Ulrike Pruefer ; Meggy Suarez-Carmona ; Anja Williams ; Jürgen Krauss ; Jarf Ulf Jungelius ; Nicolas Hohmann ; Anna Frömming ; Dirk Eulberg ; Aram Mangasarian ; Matthias Baumann ; Dirk Jäger ; Diana Beyer

Background:

Immunotherapy in microsatellite stable colorectal or pancreatic cancer has not shown promising results. It has been hypothesized that targeting immunosuppressive molecules like SDF1-alpha/CXCL12 could contribute to immunotherapy and animal models showed promising results on T cell activation and migration in combination with immune checkpoint inhibition.

Methods:

Here, we describe the successful application of anti-CXCL12 (NOX-A12) in patients with advanced stage pretreated metastatic colorectal and pancreatic cancer (OPERA trial). The treatment consisted of 2 weeks of anti-CXCL12 monotherapy with NOX-A12 followed by combination therapy with pembrolizumab (n=20 patients) until progression or intolerable toxicity had occurred.

Results:

The treatment was safe and well tolerated with 83.8% grade I/II, 15.5% grade III and 0.7% grade V adverse events. Of note, for a majority of patients, time on trial treatment was prolonged compared with their last standard treatment preceding trial participation. Systematic serial biopsies revealed distinct patterns of modulation. Tissue and clinical responses were associated with Th1-like tissue reactivity upon CXCL12 inhibition. A downregulation of a cytokine cassette of interleukin (IL)-2/IL-16/CXCL-10 was associated with tumor resistance and furthermore linked to a rare, CXCL12-associated CD14+CD15+promonocytic population. T cells showed aggregation and directed movement towards the tumor cells in responding tissues. Serum analyses detected homogeneous immunomodulatory patterns in all patients, regardless of tissue responses.

Conclusions:

We demonstrate that the combination of CXCL12 inhibition and checkpoint inhibition is safe and grants further exploration of synergistic combinatorial strategies.

项与 Olaptesed Pegol 相关的新闻（医药）

2026-04-30

·BioSpace

TME Pharma publishes its annual financial results and annual report

TME Pharma publishes its annual financial results and annual report Berlin, Germany , April 30, 2026, 20.00am CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for brain cancer and eye diseases, announces today its financial results for the fiscal year ending December 31, 2025. The Annual Report 2025, as approved by the management and supervisory boards on April 30, 2025, is available on TME Pharma’s website ( ). In June 2025, TME Pharma changed its organizational structure to a virtual company structure to allow it to continue pursuing the goals of financing, licensing or M&A transactions focused on its clinical stage assets, NOX-A12 and NOX-E36 while minimizing costs by outsourcing essentially all functions to maintain the programs and conduct industrial partner and investor outreach. 2025 Financial Summary On December 31, 2025, TME Pharma and its subsidiaries had cash resources of €2 million. In March 2026, TME announced that it had agreed with certain lenders, involved in the May 2025 and August 2025 financing, to extend the maturity of their loans by a further 12 months, extending the cash runway into Q2 2027 taking into consideration the current level of business operations. As in prior years, TME Pharma has not generated any revenues. The Group – TME Pharma N.V.,TME Pharma AG – does not expect to generate any revenues from any product candidates that it develops until the Group either signs a licensing agreement or obtains regulatory approval and commercializes its products or enters into collaborative agreements with third parties. The Net loss in 2025 amounted €3.3M (2024: €5.7M). Total equity as of December 31, 2025 is now €1.6M negative (December 31, 2024: €1.6M positive). Outlook for 2026 At this time, TME Pharma is focusing on securing licensing agreements or partnerships for NOX-A12 and NOX-E36. As announced in 2025, the company is also exploring alternative sources of revenue and activities as well as financing and partnering solutions for NOX-A12 and NOX-E36. TME Pharma will seek shareholder approval as required for any potential transactions which emerge as part of the new strategy and issue press releases on all material developments. Diede van den Ouden, CEO of TME Pharma , said: “As a shareholder and as a director, I remain optimistic about the future of TME Pharma. Publications, like in *Nature Communications* on triple therapy for NOX-A12, demonstrates that TME assets could hold significant potential value. It is up to us to realize that value.” For more information, please contact: TME Pharma N.V. Diede van den Ouden, CEO ir@tmepharma.com About TME Pharma TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. The Company’s two lead assets are: NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma was awarded Fast Track Designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect. The Company, under the leadership of its new CEO, Diede van den Ouden, who joined in the June 2025, and utilizing the virtual company structure it adopted at that time, is currently seeking opportunities to secure the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include: Raising funds from alternative sources Pursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the Company Leveraging tax loss carry forwards Further information can be found at: . About the GLORIA Study The GLORIA (NCT04121455) study, currently on hold, is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab. About the OPTIMUS Study OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients. Disclaimer Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law. Attachment ENG_TME Pharma publishes its annual financial results and annual report

孤儿药引进/卖出临床2期快速通道财报

2026-04-19

·药明康德

HER2靶向ADC临床2期积极结果公布；潜在“first-in-class”小分子临床结果积极…… | 一周盘点

本期看点： 1. BioNTech和映恩生物（DualityBio）宣布，接受其在研HER2靶向抗体偶联药物（ADC）trastuzumab pamirtecan治疗的晚期子宫内膜癌患者的确认客观缓解率（ORR）近50%。 2. Bold Therapeutics宣布其潜在“first-in-class”小分子BOLD-100联合化疗方案FOLFOX治疗的胃肠癌患者，其oxaliplatin诱导的周围神经病变（OIPN）发生率显著低于历史对照水平。 Trastuzumab pamirtecan：1/2a期试验结果公布 BioNTech和映恩生物（DualityBio）近日公布了其在研HER2靶向ADC疗法trastuzumab pamirtecan（BNT323/DB-1303）的一项2期队列主要分析结果。该研究纳入HER2表达阳性的晚期子宫内膜癌患者，这些患者在一线化疗后（部分患者曾接受免疫检查点抑制剂治疗）疾病仍出现进展。该队列属于一项全球1/2a期临床试验的一部分，旨在评估trastuzumab pamirtecan在多种实体瘤中的治疗潜力。研究结果显示，该药物单药治疗在不同HER2免疫组化表达水平（IHC1+、IHC2+、IHC3+）患者中均表现具有明确临床意义的疗效。本次2期队列分析共纳入145例HER2表达阳性的晚期或转移性子宫内膜癌患者，其中经中心实验室确认HER2状态且曾接受免疫检查点抑制剂治疗的73例患者达到主要终点，ORR为49.3%（95% CI：37.4–61.3）。在所有经中心检测的患者（n=96）中，确认ORR为47.9%，中位无进展生存期为8.1个月。按当地检测HER2状态评估的143例可评估患者中，确认ORR为44.1%，不同HER2表达水平患者均观察到抗肿瘤活性，其中IHC1+、IHC2+和IHC3+患者的ORR分别为33.9%、40.4%和73.1%，中位缓解持续时间为10.3个月。安全性方面，该疗法的不良反应总体与HER2靶向ADC已知特征一致，常见治疗相关不良事件包括轻度恶心、贫血、血小板减少和疲劳。 BOLD-100：2期试验结果公布 Bold Therapeutics近日公布了其核心在研药物BOLD-100的最新数据，显示该药物在减轻化疗相关周围神经病变方面具有潜在保护作用。BOLD-100是基于钌基的潜在“first-in-class”小分子药物，其能（1）通过选择性抑制GRP78蛋白以改变未折叠蛋白质反应（UPR）；以及（2）诱导活性氧（ROS）引起的DNA损伤和细胞周期停滞。这些效果可共同导致对药物敏感和具耐药性的癌细胞死亡，使得BOLD-100在与其他抗癌疗法组合时（包含传统化疗、靶向疗法和免疫肿瘤疗法），具潜在改善各种实体和液体肿瘤预后的效果。 FOLFOX虽为胃肠道肿瘤的一线标准化疗方案，但其临床应用常受到急性及慢性周围神经病变的限制，大多数患者在治疗过程中会出现不同程度的不良反应。在正在进行的2期研究中，接受BOLD-100联合FOLFOX治疗的患者，其oxaliplatin诱导的周围神经病变发生率显著低于历史对照水平。具体来看，在结直肠癌患者中，任意级别神经病变发生率为14%，明显低于53%的历史基准；在胆道肿瘤患者中为35%，低于58%；在胃癌患者中为19%，显著低于63%。Bold Therapeutics公司将在正在举行的美国癌症研究协会（AACR）年会上分享BOLD-100神经保护功能的临床前研究结果和潜在作用机制。 STC-15：2期试验首例患者给药日前，STORM Therapeutics宣布完成5600万美元C轮融资，融资所得资金将主要用于推进其在研候选药物STC-15的临床开发。目前，公司已启动STC-15在特定肉瘤适应症中的2期单药临床研究，并已成功完成首例患者给药。肉瘤是一类发生于骨或软组织的恶性肿瘤，可累及肌肉、脂肪、软骨、血管以及其他结缔或支持性组织。本项研究旨在为STC-15探索潜在的加速审批路径提供支持，并为未来在更多肿瘤适应症中的临床开发奠定基础。 STC-15是一种潜在“first-in-class”口服小分子METTL3抑制剂。STC-15通过抑制RNA修饰酶METTL3发挥作用。该酶参与调控癌症干细胞分化过程，而这一过程在肉瘤及多种恶性肿瘤的发生发展中具有关键作用。在此前开展的1期单药临床研究中，STC-15在多种肉瘤亚型患者中显示出持久的肿瘤缓解效果，提示该疗法有望通过靶向并重编程可转化为癌细胞的祖细胞发挥抗肿瘤作用。参考资料： [1] BioNTech and DualityBio’s Antibody-Drug Conjugate Trastuzumab Pamirtecan Demonstrated Clinically Meaningful Efficacy in Patients with HER2-Expressing, Recurrent Endometrial Cancer. Retrieved April 13, 2026 from https://www.globenewswire.com/news-release/2026/04/11/3272109/0/en/BioNTech-and-DualityBio-s-Antibody-Drug-Conjugate-Trastuzumab-Pamirtecan-Demonstrated-Clinically-Meaningful-Efficacy-in-Patients-with-HER2-Expressing-Recurrent-Endometrial-Cancer.html [2] STORM Therapeutics Secures $56 Million Series C Financing and Doses First Patient in Phase 2 Sarcoma Trial of STC‑15. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/16/3275048/0/en/STORM-Therapeutics-Secures-56-Million-Series-C-Financing-and-Doses-First-Patient-in-Phase-2-Sarcoma-Trial-of-STC-15.html [3] TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1/2 Expansion Arm A Findings from GLORIA trial in Nature Communications. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/16/3275041/0/en/TME-Pharma-Announces-Publication-of-NOX-A12-Triple-Therapy-Phase-1-2-Expansion-Arm-A-Findings-from-GLORIA-trial-in-Nature-Communications.html [4] Hinge Bio Announces First Subject Dosed in Phase 1 Trial of HB2198, a Novel B cell Depleting Agent, for Treating Autoimmune Disease. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/14/3273253/0/en/Hinge-Bio-Announces-First-Subject-Dosed-in-Phase-1-Trial-of-HB2198-a-Novel-B-cell-Depleting-Agent-for-Treating-Autoimmune-Disease.html [5] Oragenics Doses First Patient in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/13/3272489/0/en/Oragenics-Doses-First-Patient-in-Phase-IIa-Clinical-Trial-of-ONP-002-for-Mild-Traumatic-Brain-Injury.html [6] ImPact Biotech Presents Preliminary Data from Phase 1 Study of Padeliporfin VTP in LA-PDAC at SIR 2026 and Provides Strategic Business Update. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/13/3272459/0/en/ImPact-Biotech-Presents-Preliminary-Data-from-Phase-1-Study-of-Padeliporfin-VTP-in-LA-PDAC-at-SIR-2026-and-Provides-Strategic-Business-Update.html [7] MetaVia Doses the First Patient in Higher-Dose Phase 1 Study of DA-1726, Its GLP-1 and Glucagon Dual Agonist for the Treatment of Obesity. Retrieved April 17, 2026 from https://www.prnewswire.com/news-releases/metavia-doses-the-first-patient-in-higher-dose-phase-1-study-of-da-1726-its-glp-1-and-glucagon-dual-agonist-for-the-treatment-of-obesity-302738622.html [8] Bold Therapeutics' Clinical-Stage Anticancer Agent BOLD-100 Demonstrates Protective Effects Against Chemotherapy-Induced Peripheral Neuropathy. Retrieved April 17, 2026 from https://www.prnewswire.com/news-releases/bold-therapeutics-clinical-stage-anticancer-agent-bold-100-demonstrates-protective-effects-against-chemotherapy-induced-peripheral-neuropathy-302744025.html [9] Cellectar Enrolls First Patient in CLR 125 Auger-Emitting Radioconjugate Phase 1b Clinical Trial Targeting Refractory Triple Negative Breast Cancer (TNBC). Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/14/3273404/29076/en/Cellectar-Enrolls-First-Patient-in-CLR-125-Auger-Emitting-Radioconjugate-Phase-1b-Clinical-Trial-Targeting-Refractory-Triple-Negative-Breast-Cancer-TNBC.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

2026-04-16

·BioSpace

TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1/2 Expansion Arm A Findings from GLORIA trial in Nature Communications

TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1/2 Expansion Arm A Findings from GLORIA trial in Nature Communications Berlin, Germany , April 16, 2026, 08.00am CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for braincancer and eye diseases, is pleased to announce a Nature Communications article on the results from the Phase 1/2 expansion Arm A cohort of the GLORIA trial testing NOX-A12 + radiotherapy + anti-VEGF “triple therapy” in glioblastoma patients. The article in the scientific peer-reviewed high-impact journal, Nature Communications, describes results of the expansion cohort Arm A in TME Pharma’s Phase 1/2 GLORIA trial. In this arm, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients with residual tumor after surgery received NOX-A12 + radiotherapy + anti-VEGF (bevacizumab) “Triple Therapy”. The authors noted that overall survival (OS) of patients receiving NOX-A12 Triple Therapy significantly outperformed two different cohorts of similar patients external to the trial who received standard of care treatment, and further noted that due to the conservative trial design, the study “likely underestimates survival compared with most contemporary trials.” As already disclosed in the March 5, 2024 press release, the GLORIA trial has been amended to allow inclusion of 100 additional patients in a randomized, controlled Phase 2 part of the trial composed of 5 additional arms (Expansion Group Arms D through H) to assess three different doses of NOX-A12 in the Triple Therapy, one dose of NOX-A12 + radiotherapy and standard of care. It is planned to initiate this Phase 2 part of the trial once appropriate partnerships are in place. The findings described in the publication demonstrate the potential and value of TME Pharma’s NOX-A12 asset. TME Pharma remains confident in its strategy to search for a strategic partner to outlicense NOX-A12with the goal of bringing NOX-A12 to market authorization. As communicated on January 5, 2026, TME Pharma continues its active discussions with potential partners for the NOX-A12 program. As indicated in its press release of March 9, 2026, TME Pharma’s financial runway now extends to Q2-2027, providing the company with the flexibility to identify the optimal partnership for NOX-A12. Diede van den Ouden, CEO of TME Pharma , said: "We are encouraged by the publication in Nature Communications, which underscore the scientific validity of our approach. We remain fully committed to bringing NOX-A12 to success and believe that a strategic partnership is the optimal path forward. With our extended cash runway, we are well-positioned to continue our negotiations with potential partners." The full article can be found for reading through the TME Pharma website. Through the TME Pharma website > Scientific Approach > Scientific Publications and on the landing page. For more information, please contact: TME Pharma N.V. Diede van den Ouden, CEO ir@tmepharma.com About TME Pharma TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. The Company’s two lead assets are: NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma was awarded Fast Track Designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect. The Company, under the leadership of its new CEO, Diede van den Ouden, who joined in the June 2025, is currently undertaking a strategic restructuring with the goal of providing the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include: Raising funds from alternative sources (€1.7 million raised in May 2025, including €500,000 from the new CEO) Pursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the Company Leveraging tax loss carry forwards Potentially gaining exposure to digital assets Further information can be found at: . About the GLORIA Study GLORIA (NCT04121455) is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab. About the OPTIMUS Study OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients. Disclaimer Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law. Management will now iParallel to its core biotechnology activities, the company is exploring potential acquisitions and partnerships in stable, profitable businesses. These efforts are aimed at creating a fundamentally profitable corporate structure in which revenues from non-core activities will support and strengthen the further development of its patented drug candidates, which remain the company's flagship products, NOXA12 and NOX-E36. Attachment ENG_TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1_2 Expansion Arm A Findings from GLORIA trial in Nature Communications

临床2期快速通道孤儿药临床结果

100 项与 Olaptesed Pegol 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB11707

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
转移性胰腺腺癌	临床2期	-	TME Pharma NV	2026-01-01
胶质母细胞瘤	临床2期	德国	TME Pharma NV	2019-09-12
转移性结直肠癌	临床2期	德国	TME Pharma NV	2017-04-18
转移性胰腺癌	临床2期	德国	TME Pharma NV	2017-04-18
复发性慢性淋巴细胞白血病	临床2期	奥地利	TME Pharma NV	2012-03-01
复发性慢性淋巴细胞白血病	临床2期	比利时	TME Pharma NV	2012-03-01
复发性慢性淋巴细胞白血病	临床2期	法国	TME Pharma NV	2012-03-01
复发性慢性淋巴细胞白血病	临床2期	意大利	TME Pharma NV	2012-03-01
复发性多发性骨髓瘤	临床2期	奥地利	TME Pharma NV	2012-03-01
复发性多发性骨髓瘤	临床2期	法国	TME Pharma NV	2012-03-01

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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


NCT04121455 (GLORIA, SNO2023)	临床1/2期	胶质母细胞瘤 MGMT-unmethylated	6	Olaptesed Pegol (NOX-A12) + Bevacizumab	網範窪廠鏇餘淵繭遞糧(遞夢襯醖鏇鑰遞廠範餘) = Of all G≥2 AEs (n = 79), two G2 events (2.5%) were deemed related to NOX-A12 only 襯廠襯鏇壓鹹顧積鑰衊 (製鹽願簾餘鬱憲餘艱鏇 ) 更多	积极	2023-11-10
NCT04121455 (GLORIA, ASCO2023) 人工标引	临床1/2期	胶质母细胞瘤一线 CXCL12 expressing	25	RT + NOX-A12	齋衊襯選餘窪簾糧膚壓(製蓋淵膚醖衊蓋衊窪顧) = 齋鹽鹹淵壓鹹窪獵淵膚壓糧齋築淵襯鹽淵夢簾 (餘廠觸遞餘襯醖觸醖築, 4.7–18.4) 更多	积极	2023-05-31
NCT04121455 (GLORIA, ASCO2023) 人工标引	临床1/2期	胶质母细胞瘤一线 CXCL12 expressing	25	RT + NOX-A12 (high EG12 score)	鏇遞廠鬱觸廠膚簾鬱簾(獵築遞築壓窪範顧築廠) = 襯顧遞築艱膚選簾顧觸範齋憲願鬱網齋構鑰鑰 (夢衊繭蓋鑰簾憲齋鑰簾 ) 更多	积极	2023-05-31
NCT04121455 (GLORIA, SNO2022) 人工标引	临床1/2期	胶质母细胞瘤 MGMT Promoter Methylation Negative	6	bevacizumab+NOX-A12	齋製獵鹹膚膚範夢構製(網鏇鹽築遞壓壓艱願鹽) = Of all G ≥ 2 AEs (n = 37), two G2 events (5.4%) were deemed related to NOX-A12. 鑰鹹構鑰夢齋選壓淵鏇 (築顧蓋鹽遞糧醖繭獵繭 )	积极	2022-11-14
NCT04121455 (GLORIA, Corporate Publications) 人工标引	临床1/2期	胶质母细胞瘤	-	Radiotherapy+NOX-A12	選製淵醖積廠蓋遞憲鹽(齋鹽製鏇糧築鏇鏇艱簾) = 憲積製鑰網廠製醖繭艱積鬱蓋蓋範範窪範齋顧 (鑰鹽襯網觸製鬱選網醖 ) 更多	积极	2022-06-05
NCT04121455 (GLORIA, Corporate Publications) 人工标引	临床1/2期	胶质母细胞瘤	-	Standard of Care	壓築製衊顧網積膚淵範(鏇願觸遞鏇積構遞鑰願) = 壓網衊淵築製廠觸鹽範遞觸壓選鹽網顧網齋壓 (餘壓糧淵憲壓衊獵範觸 ) 更多	积极	2022-06-05
NCT04121455 (GLORIA, ASCO2022) 人工标引	临床1/2期	胶质母细胞瘤 MGMT	10	Olaptesed pegol	築糧壓窪衊鏇範鏇憲獵(顧憲齋製築鏇憲蓋構築) = 積壓憲醖膚衊膚壓鬱衊膚繭窪製顧鹹衊衊衊壓 (顧衊齋淵鹽製憲鬱鹹壓 ) 更多	积极	2022-06-02
NCT03168139 (Opera, ESMO2020)	临床1/2期	转移性微卫星稳定结直肠癌	20	NOX-A12	網蓋餘鑰網簾蓋襯範廠(觸淵襯願繭繭鏇選鬱構) = The AE profile was comparable with the pembrolizumab profile and typical for the underlying diseases. 夢顧獵蓋壓顧醖鑰繭夢 (廠構夢糧蓋繭廠繭選網 )	积极	2020-09-17
NCT03168139 (Opera, AACR 12020 \| AACR 22020) 人工标引	临床1/2期	转移性微卫星稳定结直肠癌	20	NOX-A12+pembrolizumab	艱艱艱艱憲襯鹹願觸鏇(鏇鏇齋遞齋糧繭淵顧窪) = 窪鑰餘夢餘簾鬱窪餘醖鑰範積窪簾膚製構膚夢 (鹽觸遞窪廠齋醖齋糧壓 ) 更多	积极	2020-08-15
NCT01486797 (Pubmed \| Haematologica) 人工标引	临床2期	慢性淋巴细胞白血病	28	bendamustine+rituximab+Olaptesed pegol	繭齋製獵蓋鹽獵築壓範(壓壓蓋餘鑰淵憲餘選獵) = 積廠壓餘齋鹹壓獵餘糧醖範糧構襯範齋顧夢願 (夢鹽選獵淵蓋顧繭鑰積 ) 更多	积极	2019-10-01
NCT03168139 (Opera study, ESMO2019)	临床1/2期	转移性微卫星稳定结直肠癌 microsatellite-stable	-	NOX-A12	餘艱觸鹹顧鹹鹽蓋鹽構(襯獵願衊選獵遞鑰膚鑰) = 範選夢願築齋鬱襯餘遞齋願觸醖鑰糧鏇夢顧鹽 (鬱顧繭壓願齋顧膚遞築 ) 更多	-	2019-09-29
NCT03168139 (OPERA, ASCO2019)	临床1/2期	转移性微卫星稳定结直肠癌	20	NOX-A12 + Pembrolizumab	範製夢憲廠鏇鹹廠觸淵(餘鏇構鹹淵蓋夢壓糧壓) = 遞願觸襯衊簾獵鑰選淵艱鏇獵範窪廠鏇網糧積 (壓獵窪醖餘製廠鑰繭蓋 ) 更多	积极	2019-05-26