The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.

开始日期2025-05-01

申办/合作机构

The University of Alabama at Birmingham

NCT05570422 / Not yet recruiting临床1期

A Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 Intratumoral Injection Combined With Radiotherapy in Patients With Locally Advanced Cervical Cancer

This is a seamless Phase 1/2 study consisting of two components. Phase 1 component is a dose-escalation, single arm, open label study in 10 patients to evaluate the safety and tolerability of KRC 01. Phase 2 component is a randomized, open label, controlled, multi-center study in 60 patients to evaluate the preliminary antitumor effect of KRC-01 in combination with CRT.

开始日期2025-04-01

申办/合作机构

KORTUC, Inc.初创企业

NCT06543576 / Not yet recruiting临床1/2期

A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer

This phase I/II trial tests the safety and effectiveness of receiving external beam radiation therapy (EBRT) and brachytherapy along with chemotherapy, consisting of cisplatin and paclitaxel, and immunotherapy, consisting of bevacizumab and pembrolizumab, for the treatment of patients with stage IVB cervical cancer. EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer.

开始日期2025-01-31

申办/合作机构

Jonsson Comprehensive Cancer Center

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100 项与顺铂相关的临床结果

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100 项与顺铂相关的转化医学

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100 项与顺铂相关的专利（医药）

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75,394

项与顺铂相关的文献（医药）

2106-07-05·Oncotarget

Pellino-1 confers chemoresistance in lung cancer cells by upregulating cIAP2 through Lys63-mediated polyubiquitination

Article

作者: Jeon, Yoon Kyung ; Koh, Jaemoon ; Kim, Chung Kwon ; Ha, Geun-Hyoung ; Chung, Doo Hyun

Pellino-1 is an E3 ubiquitin ligase that mediates immune receptor signaling pathways. The role of Pellino-1 in oncogenesis of lung cancer was investigated in this study. Pellino-1 expression was increased in human lung cancer cell lines compared with non-neoplastic lung cell lines. Pellino-1 overexpression in human lung cancer cells, A549 and H1299 cells, increased the survival and colony forming ability. Pellino-1 overexpression in these cells also conferred resistance to cisplatin- or paclitaxel-induced apoptosis. In contrast, depletion of Pellino-1 decreased the survival of A549 and H1299 cells and sensitized these cells to cisplatin- and paclitaxel-induced apoptosis. Pellino-1 overexpression in A549 and H1299 cells upregulated the expression of inhibitor of apoptosis (IAP) proteins, including cIAP1 and cIAP2, while Pellino-1 depletion downregulated these molecules. Notably, Pellino-1 directly interacted with cIAP2 and stabilized cIAP2 through lysine63-mediated polyubiquitination via its E3 ligase activity. Pellino-1-mediated chemoresistance in lung cancer cells was dependent on the induction of cIAP2. Moreover, a strong positive correlation between Pellino-1 and the cIAP2 expression was observed in human lung adenocarcinoma tissues. Taken together, these results demonstrate that Pellino-1 contributes to lung oncogenesis through the overexpression of cIAP2 and promotion of cell survival and chemoresistance. Pellino-1 might be a novel oncogene and potential therapeutic target in lung cancer.

2106-07-05·Oncotarget

Sensitizing mucoepidermoid carcinomas to chemotherapy by targeted disruption of cancer stem cells

Article

作者: Guimarães, Douglas M. ; Castilho, Rogerio M. ; Vargas, Pablo A. ; Warner, Kristy A. ; Martins, Manoela D. ; Nunes, Fabio D. ; Almeida, Luciana O. ; Squarize, Cristiane H. ; Silva, Alan R. S. ; Nör, Jacques E.

Mucoepidermoid carcinoma (MEC) is the most common malignancy of salivary glands. The response of MEC to chemotherapy is unpredictable, and recent advances in cancer biology suggest the involvement of cancer stem cells (CSCs) in tumor progression and chemoresistance and radioresistance phenotype. We found that histone acetyltransferase inhibitors (HDACi) were capable of disrupting CSCs in MEC. Furthermore, administration of HDACi prior to Cisplatin (two-hit approach) disrupts CSCs and sensitizes tumor cells to Cisplatin. Our findings corroborate to emerging evidence that CSCs play a key role in tumor resistance to chemotherapy, and highlights a pharmacological two-hit approach that disrupts tumor resistance to conventional therapy.

2106-07-05·Oncotarget

Radiation-enhanced therapeutic targeting of galectin-1 enriched malignant stroma in triple negative breast cancer

Article

作者: Napier, Dana ; Jyoti, Amar ; O’Halloran, Thomas V. ; Upreti, Meenakshi ; Evers, B. Mark ; Sethi, Pallavi ; Chan, Ryan ; Swindell, Elden P. ; Weiss, Heidi L. ; Johnson, Sara E. ; Feddock, Jonathan M.

Currently there are no FDA approved targeted therapies for Triple Negative Breast Cancer (TNBC). Ongoing clinical trials for TNBC have focused primarily on targeting the epithelial cancer cells. However, targeted delivery of cytotoxic payloads to the non-transformed tumor associated-endothelium can prove to be an alternate approach that is currently unexplored. The present study is supported by recent findings on elevated expression of stromal galectin-1 in clinical samples of TNBC and our ongoing findings on stromal targeting of radiation induced galectin-1 by the anginex-conjugated arsenic-cisplatin loaded liposomes using a novel murine tumor model. We demonstrate inhibition of tumor growth and metastasis in response to the multimodal nanotherapeutic strategy using a TNBC model with orthotopic tumors originating from 3D tumor tissue analogs (TTA) comprised of tumor cells, endothelial cells and fibroblasts. The 'rigorous' combined treatment regimen of radiation and targeted liposomes is also shown to be well tolerated. More importantly, the results presented provide a means to exploit clinically relevant radiation dose for concurrent receptor mediated enhanced delivery of chemotherapy while limiting overall toxicity. The proposed study is significant as it falls in line with developing combinatorial therapeutic approaches for stroma-directed tumor targeting using tumor models that have an appropriate representation of the TNBC microenvironment.

1,790

项与顺铂相关的新闻（医药）

13 小时之前

·Business Wire

Axcelead Drug Discovery Partners Enters into Master Service Agreement for Drug Discovery Projects with Acadia Pharmaceuticals

TOKYO--( BUSINESS WIRE )--Axcelead Drug Discovery Partners, Inc. (HQ: Fujisawa, Kanagawa, Japan; hereinafter referred to as “Axcelead DDP”) announced on September 10 that it had entered into a Master Service Agreement with Acadia Pharmaceuticals Inc. (HQ: San Diego, CA, USA; hereinafter referred to as “Acadia”) to support their goal of discovering and developing innovative and novel medicines to help address unmet medical needs. Axcelead DDP has already been engaged in multiple drug discovery projects in the neuroscience area to identify candidate compounds since October 2022. Acadia and Axcelead DDP have entered into the Master Service Agreement so that Axcelead DDP can more efficiently and comprehensively support certain new drug discovery projects of Acadia. Axcelead DDP will provide drug discovery support to Acadia by leveraging its integrated drug discovery platform, deep knowledge and extensive experience in drug discovery research to potentially generate high-quality candidate compounds. A new drug discovery project under the executed MSA has been launched at the same time. Axcelead DDP will receive an upfront fee, research funding and milestone fees as in the previous projects. Details of the financial terms regarding the Master Service Agreement and the new project are not disclosed. “We are pleased to announce the start of the new drug discovery project and the signing of the Master Service Agreement to contribute to Acadia's drug discovery research efforts. Our strong progress to date has led to the execution of this Master Service Agreement,” said Kengo Okada, PhD., Representative Director and CEO of Axcelead DDP. “We look forward to working with Acadia to expand their drug pipeline with the goal to bring innovative medicines to patients suffering from CNS diseases and other diseases as soon as possible.” Axcelead DDP is Japan’s first drug discovery solution provider established in July 2017 by inheriting the drug discovery platform from Takeda Pharmaceutical. Screening, medicinal chemistry, pharmacology/biology, DMPK, and safety research functions are integrated into one center with a state-of-the-art research base and original compound library. Together with the most advanced AI capability integration to Axcelead DDP’s service, Axcelead DDP is to create high quality drug candidates rapidly. By leveraging these strengths, Axcelead DDP provides solutions to various challenges faced in the process from exploratory research to clinical in drug discovery. For more information, please visit https://axcelead-us.com/ About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years Acadia has been working at the forefront of healthcare to bring vital solutions to people who need them most. Acadia developed and commercialized the first and only FDA-approved therapies for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Acadia’s clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit Acadia at https://acadia.com/

引进/卖出

2024-09-19

·美通社

在HIMALAYA III期试验中，英飞凡联合曲美木单抗在晚期肝癌中展示前所未有的总生存期，近五分之一的患者生存达五年

这是迄今为止该类针对晚期肝癌的免疫治疗 III期试验中报告的最长生存期随访结果上海 2024年9月19日 /美通社/ -- HIMALAYA III期试验的更新结果表明，对于既往未接受过全身治疗且不适用局部治疗的不可切除性肝细胞癌（HCC）患者，阿斯利康的英飞凡(通用名：度伐利尤单抗)联合曲美木单抗在5年内显示出持续、具有临床意义的总生存期(OS)获益。这些HIMALAYA研究结果于9月16日在西班牙巴塞罗那举行的欧洲肿瘤内科学会（ESMO）2024 年会上展示（报告 947MO）。在5年随访的最新探索性分析中显示，与索拉非尼相比，在度伐利尤单抗加入曲美木单抗单次给药的STRIDE治疗方案（单次曲美木单抗，常规间隔度伐利尤单抗），死亡风险降低24%（基于风险比[HR]为0.76；95%置信区间[CI] 0.65-0.89）。接受STRIDE方案治疗的患者中有约有19.6%在5年内存活，而这一数字在接受索拉非尼治疗的患者中为9.4%。在试验中达到疾病控制（定义为完全或部分缓解或疾病稳定）的患者亚组分析中，28.7%接受STRIDE方案治疗的患者在5年内存活，而这一数字在接受索拉非尼治疗的患者中为12.7%。此外，缓解深度(DpR)的探索性分析显示，与索拉非尼相比，接受STRIDE方案治疗的患者获得程度更深的缓解，使生存期更长。医学博士、意大利米兰Humanitas大学和IRCC Humanitas研究医院医学肿瘤学副教授、HIMALAYA的主要研究者Lorenza Rimassa表示："度伐利尤单抗联合曲美木单抗治疗晚期肝癌患者使总生存在5年内翻倍，这是相较索拉非尼的显著生存优势，并且随着时间的推移，这种优势变得更加明显。这些研究数据强化了这种新型双免疫治疗方案的使用，对于患有这一令人绝望的疾病的患者来说，是一个重要里程碑。" 全球肝脏学会肝癌项目负责人Sarah Manes表示："达到五年生存期这一里程碑对晚期肝癌患者及其家人具有临床意义和情感意义。我们很高兴地看到，通过新疗法改善治疗结局取得了进展，这为我们患者社群的长期生存带来了新的希望。" 阿斯利康全球执行副总裁、肿瘤研发负责人Susan Galbraith表示："近20%的晚期肝癌患者接受STRIDE方案治疗后仍能存活5年，这一结果不同凡响，历史上仅约7%的患者能够存活5年。这是向前迈出的重要一步，树立了新的生存基准。这充分表明了我们致力与患者长期跟进，以帮助我们更好地塑造这种创新促发疗法的持久临床获益，即在PD-L1阻断剂中添加抗CTLA-4抗体。" 更新生存结果概要： HIMALAYA 总生存期 I,ii STRIDE 方案 (n=393) 索拉非尼 (n=389) 随访时间中位数（95% CI）（月） 62.5 (59.5-64.8) 59.9 (58.3-61.5) OS风险比（95% CI） 0.76 (0.65-0.89) p值（双边） iii 0.0008 60个月的OS率 iv （95% CI）（%） 19.6 9.4 60个月疾病控制（DC）患者数量 OS率，% 43 28.7 17 12.7 60个月 DpR v >75% 患者数量 OS率 iv ，% 27 72.7 3 33.3 60个月DpR v >50%–≤75% 患者数量 OS率 iv ，% 34 57.8 12 32.1 i.更新分析数据截止日期：2024年3月1日，OS数据成熟度为82% ii.采用校正治疗、病因、ECOG体力活动状态和大血管侵犯的Cox比例风险模型计算OS HR和95% CI iii.标称p值 iv.使用Kaplan-Meier方法估算60个月时的OS率。DpR表示最佳客观缓解评估时观察到的肿瘤相对基线缩小的百分比 STRIDE治疗方案的安全性特征与每种药物的已知特征一致，在延长的随访时间中，未观察到新的安全性信号。17.5%接受STRIDE方案治疗的患者和9.9%接受索拉非尼治疗的患者发生了严重治疗相关不良事件（定义为3级或4级，包括死亡），在STRIDE主要分析后未发生新的事件。度伐利尤单抗联合曲美木单抗用于治疗晚期或不可切除HCC成人患者已在美国、欧盟（一线治疗）、日本和其他几个国家地区获得批准。度伐利尤单抗单药治疗晚期或不可切除HCC成人患者已在日本获得批准。关于肝癌肝癌，其中HCC是最常见的类型，是第三大癌症致死病因，全世界每年有近900,000人确诊，在亚洲某些地区的发病率很高。 [1]-[2] 约80-90%的HCC患者患有肝硬化。如肝硬化的慢性肝病与炎症有关，随着时间的推移，炎症可导致HCC的发生。 [3] HCC晚期预后较差，5年生存率仅为7%。 [4] 超过一半的患者在疾病晚期确诊，这也通常是在症状首次出现时。 [5] 肝癌独特的免疫环境为利用免疫系统力量治疗HCC的药物研究提供了明确的依据。 [5] 关于 HIMALAYA 临床研究 HIMALAYA研究是一项随机、开放标签的全球多中心III期临床研究，该研究比较了度伐利尤单抗单药治疗和由300mg的单次启动剂量的曲美木单抗联用1500mg的度伐利尤单抗，随后每四周一次给药度伐利尤单抗组成的方案（STRIDE方案），与作为标准治疗的多激酶抑制剂索拉非尼单药治疗的效果。该研究共纳入1,324名不可切除HCC的成人患者。这些患者之前未接受过全身治疗，且不适合局部治疗（限于肝脏和周围组织的治疗）。该研究在16个国家地区的181个中心进行，包括美国、加拿大、欧洲、南美洲和亚洲。主要终点是联合治疗方案相比索拉非尼单药治疗的OS，关键次要终点包括度伐利尤单抗相比索拉非尼治疗的OS、联合治疗方案和度伐利尤单抗单独用药的客观缓解率和无进展生存期 (PFS)。关于度伐利尤单抗度伐利尤单抗是一种人源化的PD-L1单克隆抗体，能够阻断PD-L1与PD-1和CD80的结合，从而阻断肿瘤免疫逃逸策略并恢复被抑制的免疫反应。度伐利尤单抗被批准联合化疗（吉西他滨加顺铂）治疗局部晚期或转移性胆道癌、联合曲美木单抗治疗不可切除的肝细胞癌 (HCC)。在日本和欧盟，度伐利尤单抗也被批准单药治疗无法切除的HCC，以及用于与化疗（卡铂和紫杉醇）联用后再进行度伐利尤单抗单药维持治疗错配修复缺陷的一线晚期或复发性子宫内膜癌也在美国获得批准。除了消化道肿瘤的适应症外，度伐利尤单抗是放化疗后未出现疾病进展的III 期不可切除非小细胞肺癌（NSCLC）患者中以治愈为目的的全球标准治疗。度伐利尤单抗还获批用于治疗广泛期小细胞肺癌（SCLC），并与短疗程曲美木单抗和化疗联合用于治疗转移性NSCLC。针对SCLC，在ADRIATIC III期试验中，与安慰剂相比，度伐利尤单抗在同步放化疗的标准治疗后未出现进展的患者中，在OS和PFS的双重主要终点方面显示出具有显著统计学意义和临床意义的改善。度伐利尤单抗已在美国和其他多个国家地区获得批准，在手术前联合含铂化疗新辅助治疗和手术后单药辅助治疗，用于治疗可切除的NSCLC成人患者，且没有已知的表皮生长因子受体突变或间变性淋巴瘤激酶重排。度伐利尤单抗联合化疗后再进行度伐利尤单抗单药维持治疗一线晚期或复发性子宫内膜癌的错配修复缺陷患者的适应症最近在美国获批。此前欧盟不仅批准了该疗法，同时还批准了度伐利尤单抗联合化疗后再进行度伐利尤单抗联合奥拉帕维持治疗错配修复功能正常的一线晚期或复发性子宫内膜癌的适应症。在NIAGARA III期试验中，在肌层浸润性膀胱癌中，度伐利尤单抗联合化疗在无事件生存期的主要终点（EFS）和OS与新辅助化疗相比，关键次要终点方面显示出具有统计学意义和临床意义的改善。自2017年5月首次获批至今，已有超过22万名患者接受了度伐利尤单抗的治疗。作为整体研发计划的一部分，度伐利尤单抗正以单药或者联合其它抗肿瘤药物的方式，探索在小细胞肺癌、非小细胞肺癌、膀胱癌、乳腺癌、多种消化道肿瘤和妇科癌症以及其它实体瘤的治疗。关于曲美木单抗曲美木单抗是一种人单克隆抗体，靶向细胞毒性T淋巴细胞相关蛋白4(CTLA-4)的活性。曲美木单抗阻断CTLA-4的活性，促使T细胞活化，激发对癌症的免疫应答并促进癌细胞死亡。除了获批用于肝癌和肺癌的适应症外，曲美木单抗正在接受和度伐利尤单抗联合使用治疗多种肿瘤类型的评估，包括局部区域HCC(EMERALD-3)、SCLC(ADRIATIC)和膀胱癌（VOLGA和NILE）。关于阿斯利康在消化道肿瘤领域的研究阿斯利康在消化道肿瘤的治疗中拥有广泛的开发计划，涵盖多种肿瘤类型和疾病阶段的多种药物。2022年，消化道肿瘤共有约490万新发病例，导致约330万例病例死亡 [6] 。在该计划中，公司致力于改善胃癌、肝癌、胆道癌、食道癌、胰腺癌和结直肠癌的治疗效果。除了用于胆道癌和肝细胞癌的适应症外，公司正通过涵盖从早期到晚期疾病的广泛开发计划，评估度伐利尤单抗的联合用药方案，其中包含曲美木单抗，用于治疗肝癌、食管癌和胃癌。公司还在评估一种PD-1/TIGIT双特异性抗体rilvegostomig(AZD2936)，将该抗体作为辅助疗法联合化疗用于治疗胆道癌，以及一线治疗HER2阴性局部晚期不可切除或转移性食管胃结合部癌。德曲妥珠单抗是一款靶向HER2的抗体偶联药物，在美国、中国和其他几个国家获批用于治疗HER2阳性晚期胃癌，目前正在结直肠癌中接受评估。在DESTINY-PanTumor02 II期试验中，该药物已在包括胆道癌在内的多种消化道肿瘤中进行了评估，并且最近在美国获批用于治疗既往接受过全身治疗且无令人满意的替代治疗方案的不可切除或转移性HER2阳性实体瘤。德曲妥珠单抗由阿斯利康和第一三共共同开发和商业化。奥拉帕利是一种首创PARP抑制剂，在美国、欧盟和其他几个国家获批用于治疗BRCA突变的转移性胰腺癌。奥拉帕利由阿斯利康和默沙东联合开发和商业化。阿斯利康正在推进多种疗法，为靶向Claudin 18.2，一个有前景的胃癌治疗靶点，提供互补机制。其中包括AZD0901，一种潜在的同类首个抗体偶联药物，获得KYM Biosciences Inc.授权，目前处于III期开发阶段；AZD5863，获得和铂医药授权的一种新型Claudin 18.2/CD3 T细胞衔接双特异性抗体，目前处于I期开发阶段；以及AZD6422，一种装甲型自体嵌合抗原受体T细胞(CAR-T)疗法，目前正与西比曼合作在中国的一项由研究者发起的临床研究(IIT)中进行评估。在早期开发方面，阿斯利康正在开发两种针对HCC的Glypican 3(GPC3)装甲CAR-T疗法。AZD5851目前处于I期开发阶段，正在全球范围内进行开发，以及C-CAR031/AZD7003正与西比曼合作在中国联合开发，在IIT中进行评估。关于阿斯利康在肿瘤免疫治疗 (IO)的研究阿斯利康是将免疫疗法引入高度未被满足的临床医疗需求的先驱，拥有全面和多样化的免疫产品组合和管线，以免疫疗法为基础，旨在克服抗肿瘤免疫逃逸，并刺激人体免疫系统攻击肿瘤。阿斯利康旨在通过度伐利尤单抗单药治疗以及与曲美木单抗或其它创新免疫疗法和机制联合用药的方式重构癌症治疗，帮助患者改变治疗结局。公司也正在探索如双特异性抗体等下一代免疫疗法，利用免疫的不同特质来靶向癌症治疗，包括细胞疗法和T细胞衔接器。阿斯利康正在大胆追求创新的临床策略，将基于免疫的疗法引入各种类型的肿瘤治疗中，以期带来长期生存获益。公司专注于探索新型联合疗法，来帮助预防耐药问题并促进更长时间的免疫应答。凭借丰富的临床研究项目，公司还倡导疾病早期使用免疫治疗，因为在这个阶段有极大的潜力达到治愈。关于阿斯利康肿瘤领域的研究阿斯利康正引领着肿瘤领域的一场革命，致力提供多元化的肿瘤治疗方案，以科学探索肿瘤领域的复杂性，发现、研发并向患者提供改变生命的药物。阿斯利康专注于最具挑战性的肿瘤疾病，通过持续不断的创新，阿斯利康已经建立了领先全行业的多元化产品组合和管线，持续推动医疗实践变革，改变患者体验。阿斯利康以期重新定义癌症治疗并在未来攻克癌症。声明：本文涉及未在中国获批的产品或者适应症，阿斯利康不推荐任何未被批准的药品使用。参考文献 World Health Organization. Liver Cancer Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/11-liver-and-intrahepatic-bile-ducts-fact-sheet.pdf . Accessed September 2024 . Liu Y, et al. Changes in the Epidemiology of Hepatocellular Carcinoma in Asia. Cancers ( Basel ) . 2022;14(18):4473. Tarao K, et al. Real impact of liver cirrhosis on the development of hepatocellular carcinoma in various liver diseases—meta–analytic assessment. Cancer Med . 2019;8(3):1054-1065. Sayiner M, et al. Disease Burden of Hepatocellular Carcinoma: A Global Perspective. Digestive Diseases and Sciences. 2019;64: 910-917. Colagrande S, et al. Challenges of advanced hepatocellular carcinoma. World J Gastroenterol . 2016;22(34):7645-7659. World Health Organization. Cancer factsheets: Digestive organs (oesophagus, anus, stomach, colon, rectum, liver and intrahepatic bile ducts, pancreas, gallbladder). Available at: https://gco.iarc.fr/today/en/fact-sheets-cancers. Accessed September 2024 .

临床3期临床结果免疫疗法

2024-09-18

·GlobeNewswire-Health Care

NANOBIOTIX Provides Business Update and Reports Half Year 2024 Financial Results

RT-NBTXR3 followed by anti-PD-1 demonstrated favorable safety profile, disease control and tumor response in patients both naïve and resistant to anti-PD-1, suggesting that NBTXR3 may prime the immune system before checkpoint therapySeveral clinical milestones expected over the next 12-18 months including updated data in pancreatic, and head and neck cancer, and initial data in esophageal and lung cancer€66.3 million in cash and cash equivalents as of June 30, 2024, with a cash runway extended into Q4 2025 PARIS and CAMBRIDGE, Mass., Sept. 18, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering nanoparticle-based approaches to expand treatment possibilities for patients with cancer and other major diseases, provided an update on operational progress and announced its half year financial results for the six-month period ended June 30, 2024. “We continue to make strong progress advancing our nanoparticle-based therapeutic approach with lead candidate NBTXR3, which is part of our global licensing agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company. The agreement is designed to realize significant therapeutic and market opportunities in solid tumor cancers worldwide, starting with lung and head and neck. We also continue to establish additional expansion opportunities across multiple cancer settings as part of our ongoing collaboration with MD Anderson,” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. “The potential of NBTXR3 to prime immune activity before an anti-PD-1 inhibitor was further reinforced with new data from Study 1100 announced at the Annual Meeting of American Society for Clinical Oncology (ASCO) showing disease control and tumor response in patients with head and neck cancer that are naïve or resistant to prior anti-PD-1 therapy. We expect several clinical milestones over the next 12-18 months that, would further advance and broaden the potential patient population for NBTXR3 including updated data in pancreatic and head and neck cancer, and initial data in esophageal and lung cancer.” First Half 2024 Operational Highlights, Pipeline Status and Expected Milestones Strengthened Supervisory Board with the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers, two key additions intended to further equip the Company for sustainable long-term growth. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy, and Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors. Achieved a NANORAY-312 operational milestone as part of global exclusive licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company, for the investigational, potential first-in-class radioenhancer NBTXR3 and subsequently received the $20 million payment. Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): Local Control as Single Agent Activated by Radiotherapy (RT) NANORAY-312, a pivotal, global, randomized Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT ± cetuximab in elderly patients ineligible for cisplatin chemotherapy Interim analysis to be reported after both the requisite number of events has occurred and the last patient is recruited, expected by 1H2026Ongoing transfer of the sponsorship to Janssen to facilitate preparations for potentially positive trial results and subsequent steps Study 102, a successfully completed Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 in patients ineligible for cisplatin chemotherapy or intolerant to cetuximab. Final results showed topline safety and efficacy data supporting robust anti-tumor activity and a well-tolerated profile in elderly patients with a high burden of comorbidity (n=56) Non-Small Cell Lung Cancer (NSCLC) Janssen-led randomized Phase 2 study evaluating NBTXR3 + chemoradiation followed by anti-PD-L1 for patients with inoperable, stage 3 NSCLC Study may proceed letter received from the Food and Drug Administration (FDA)First patient randomized is the next expected milestone Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC): Priming Immune Response Followed by an Anti-PD-1 Treatment: Study 1100, a Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 followed by an anti-PD-1 as a second-or-later line treatment in patients with advanced cancers Completed dose escalation part – ongoing dose expansion part. New data in R/M HNSCC Naïve or Resistant to Anti-PD-1 presented at ASCO: Favorable safety and feasibility in 68 heavily pre-treated patients with R/M-HNSCC (Intention-to-Treat population; “ITT”)48% overall response rate (ORR) in evaluable anti-PD-1 naïve patients (n=25); 28% ORR in evaluable anti-PD-1 resistant patients (n=25) as per RECIST 1.176% disease control rate (DCR) in evaluable naïve patients; 68% DCR in evaluable resistant patients as per RECIST 1.1Preliminary review of survival data in ITT anti-PD-1 naïve patients (n=33) showed mPFS of 7.3 months and mOS of 26.2 monthsITT anti-PD-1 resistant patients (n=35) showed mPFS of 4.2 months and mOS of 7.8 months Initial data from immunotherapy resistant patients with multiple primary tumors expected in 2025Data supports further evaluation in randomized clinical trials which may include a potential registrational pathway for NBTXR3 in combination with an immunotherapy. Pancreatic, Lung and Others: Expanding NBTXR3 Opportunity Through a Strategic Collaboration with The University of Texas MD Anderson Cancer Center to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profiles Five ongoing clinical trials in advanced solid tumors: Advanced Solid Tumors with Lung or Liver Metastases: Phase 1/2 study (NCT05039632) of RT-activated NBTXR3 plus an anti-PD-1/L-1 immune checkpoint inhibitorRecurrent or Metastatic Head and Neck Cancer: Phase 2 study (NCT04862455) of RT-activated NBTXR3 in combination with anti-PD-1Inoperable Non-Small Cell Lung Cancer (NSCLC): Phase 1 study (NCT04505267) of single agent RT-activated NBTXR3 Dose escalation completed and dose expansion ongoing. Established RP2D after determination of injection feasibility and observation of a favorable safety profile. Esophageal Cancer: Phase 1 study (NCT04615013) of RT-activated NBTXR3 in combination with chemotherapy Pancreatic Cancer: Phase 1b study (NCT04484909) of RT-activated NBTXR3 after cytotoxic chemotherapy for patients with locally advanced pancreatic cancer (LAPC) Multiple expected clinical milestones: Updated Phase 1b dose escalation data in pancreatic cancer expected 2H2024Initial Phase 1 dose escalation data in inoperable, recurrent NSCLC amenable to re-irradiation expected 1H2025Completion of dose escalation in Phase 1b/2 trial in esophageal cancer expected in 2024, initiation of dose expansion part, and presentation of first data in 2025 Half Year 2024 Financial Results Revenue and Other Income: Revenue and other income has increased for the six months ended June 30, 2024, to €9.3 million, compared to €3.3 million for the six months ended June 30, 2023, primarily resulting from services and product supply revenue linked to the exclusive licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV executed on July 7, 2023. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and manufacturing expenses related to the development of NBTXR3. These expenses for the six months ended June 30, 2024, were €22.0 million, primarily driven by an increase of the clinical development activities in NANORAY-312, compared to €17.8 million for the six months ended June 30, 2023. Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. Total SG&A expenses for the six months ended June 30, 2024, were €10.8 million, compared to €10.9 million for the prior-year six-month period. Net loss: Net loss attributable to common shareholders for the six months ended June 30, 2024, was €21.9 million, or a €0.46 basic loss per share. This compares to a net loss attributable to common shareholders of €28.1 million, or €0.80 basic loss per share, for the same period in 2023. Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2024, were €66.3 million, compared to €75.3 million as of December 31, 2023. Based on the current operating plan and financial projections, we anticipate that the cash and cash equivalents of €66.3 million as of June 30, 2024, will now fund our operations into Q4 2025, compared to Q3 2025 in prior guidance. Availability of the Half Year 2024 Financial Reports The 2024 half-year financial report has been filed with the French financial market authority (Autorité des marchés financiers). It is available to the public on the Company’s website, www.nanobiotix.com. About NBTXR3 NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 patent families associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter DisclaimerThis press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 24, 2024 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2023 universal registration document filed with the AMF on April 24, 2024, in Nanobiotix’ 2024 semi-annual report under the caption “Supplemental Risk Factor” filed with the SEC on Form 6-K and with AMF on September 18 2024, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts NanobiotixCommunications DepartmentBrandon OwensVP, Communications+1 (617) 852-4835contact@nanobiotix.comInvestor Relations DepartmentCraig WestSVP, Investor Relations+1 (617) 583-0211investors@nanobiotix.comMedia RelationsFR – Ulysse CommunicationLaurent Wormser+ 33 (0)6 13 12 04 04lwormser@ulysse-communication.comGlobal – LifeSci AdvisorsKevin Gardner+1 (617) 283-2856kgardner@lifesciadvisors.com Attachment 2024-09-18 -- NBTX -- 1H24 Financial Results -- FINAL

临床1期临床2期引进/卖出免疫疗法临床3期

100 项与顺铂相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00275	顺铂	L01XA01	DB00515

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
胆道癌	日本	Nippon Kayaku Co., Ltd.	2012-02-22
恶性胸膜间皮瘤	日本	Nippon Kayaku Co., Ltd.	2007-01-04
儿童恶性实体瘤	日本	Nippon Kayaku Co., Ltd.	2005-09-15
淋巴瘤	日本	Nippon Kayaku Co., Ltd.	2005-09-15
骨癌	日本	Nippon Kayaku Co., Ltd.	2005-02-14
子宫内膜癌	日本	Nippon Kayaku Co., Ltd.	2005-02-14
生殖细胞瘤	日本	Nippon Kayaku Co., Ltd.	2004-05-31
肝细胞癌	日本	Nippon Kayaku Co., Ltd.	2004-01-29
骨肉瘤	日本	Nippon Kayaku Co., Ltd.	1999-12-21
小细胞肺癌	日本	Nippon Kayaku Co., Ltd.	1999-12-21
胃癌	日本	Nippon Kayaku Co., Ltd.	1990-06-03
食管癌	日本	Nippon Kayaku Co., Ltd.	1988-05-30
神经母细胞瘤	日本	Nippon Kayaku Co., Ltd.	1988-05-30
宫颈癌	日本	Nippon Kayaku Co., Ltd.	1988-05-30
头颈部肿瘤	日本	Nippon Kayaku Co., Ltd.	1986-08-28
非小细胞肺癌	日本	Nippon Kayaku Co., Ltd.	1986-08-28
肾肿瘤	日本	Nippon Kayaku Co., Ltd.	1983-09-21
前列腺癌	日本	Nippon Kayaku Co., Ltd.	1983-09-21
尿路上皮癌	日本	Nippon Kayaku Co., Ltd.	1983-09-21
输尿管肿瘤	日本	Nippon Kayaku Co., Ltd.	1983-09-21

未上市

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
输卵管癌	临床3期	美国	GSK Plc	2024-03-08
原发性腹膜癌	临床3期	美国	GSK Plc	2024-03-08
恶性胸腔积液	临床3期	中国	江苏先声药业有限公司	2021-05-31
转移性胃腺癌	临床3期	美国	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	日本	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	阿根廷	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	比利时	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	加拿大	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	捷克	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	丹麦	Eli Lilly & Co.	2015-01-20

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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


ESMO2024 人工标引	临床2期	非小细胞肺癌	120	Cisplatin 75mg/m2 (group I)	選齋網艱齋衊膚鏇範範(鑰糧簾鹽鏇願衊顧廠鑰) = more frequent in group I 夢糧夢淵窪構願艱獵醖 (餘壓憲鹽製餘網夢鹽觸 ) 更多	积极	2024-09-14
				Cisplatin 50mg fixed dose (group II)
WCLC2024 人工标引	N/A	非小细胞肺癌 III期	202	Cisplatin-etoposide	醖膚鏇鑰餘遞製簾製糧(繭醖鏇餘憲簾構襯顧繭) = CP was better tolerated with a lower incidence of grade 3-4 adverse events, including hematologic and gastrointestinal toxicities, compared to PE regimens. 47 (23%) pneumonitis events were reported. 壓膚夢網顧衊襯淵積襯 (顧糧齋選鑰襯遞鏇簾壓 )	积极	2024-09-07
				Carboplatin-etoposide
WCLC2024 人工标引	N/A	ES-SCLC 一线	1,144	carboplatin/cisplatin plus atezolizumab/durvalumab, with/without etoposide	齋簾憲願鹽獵襯遞選範(觸廠憲艱憲選窪艱餘憲) = 築糧糧淵淵艱窪衊鑰遞網網願鬱夢積衊鏇蓋鑰 (選廠獵衊窪簾選築醖淵 ) 更多	积极	2024-09-07
				carboplatin/cisplatin plus atezolizumab/durvalumab, with/without etoposide (receiving ≥1 cycle of immunotherapy as maintenance treatment (maintenance subgroup))	廠襯蓋製鑰構齋鏇範選(餘築遞構遞鬱願窪範廠) = 襯夢廠願顧鹽壓網網積網範顧糧艱蓋憲艱鏇簾 (鏇築觸夢願壓網積廠範, 5.6 ~ 6.0) 更多
NCT03141359 (LCI-LUN-NSC-SBRT-001, CTgov)	临床2期	非小细胞肺癌 II期 \| 局部晚期恶性肿瘤 \| 局部晚期非小细胞肺癌	61	Platinum+Etoposide+Carboplatin+Paclitaxel+durvalumab	齋顧膚遞廠觸繭糧鹽鹹(構糧膚選醖顧願範夢艱) = 餘糧餘鑰蓋鑰築網襯製襯窪鏇膚膚膚蓋壓簾艱 (襯遞糧衊糧願襯鏇窪觸, 積鹹築築積製選壓廠積 ~ 淵獵窪糧鹹範鹹選願窪) 更多	-	2024-08-29
NCT03387085 (QUILT-3.067, CTgov)	临床1/2期	三阴性乳腺癌	9	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+ETBX-011+5-fluorouracil+N-803+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK for Infusion+Leucovorin+GI-6207+Cisplatin+Bevacizumab+Capecitabine	範構鏇餘鏇鏇醖鹽衊繭(鹽範觸築構鹹觸襯襯鏇) = 鏇鬱築餘願淵構鹹蓋鬱獵廠襯選顧鬱糧窪齋廠 (鬱壓製齋艱積膚獵簾餘, 窪獵選醖醖構顧獵簾窪 ~ 繭鏇鏇顧鬱鹽選繭淵鏇) 更多	-	2024-08-09
NCT03387111 (CTgov)	临床1/2期	鳞状细胞癌	4	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+cetuximab+ETBX-061+ETBX-051+ETBX-011+Necitumumab+fluorouracil+N-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+Leucovorin+GI-6207+Cisplatin+Bevacizumab+Capecitabine	鬱獵網製膚憲膚糧構蓋(鏇構壓襯糧鑰鹹積簾窪) = 夢齋襯簾壓鑰廠築窪願選夢壓遞願餘襯遞夢選 (鑰範壓鑰夢製願糧積鑰, 夢壓膚窪廠淵壓窪淵願 ~ 齋窪鏇鬱艱餘範鏇製製) 更多	-	2024-08-05
NCT02777385 (CTgov)	临床2期	头颈部鳞状细胞癌	80	Cisplatin+Pembrolizumab (Cisplatin + Radiation + Pembrolizumab - Concurrent)	淵齋鬱願膚選獵窪顧襯(積夢網壓獵廠衊襯製構) = 製夢廠壓繭願衊遞遞鬱鏇觸糧夢築壓鏇壓夢鑰 (築網鑰鬱鑰衊鹹簾淵積, 構膚餘夢範糧願衊夢選 ~ 製醖願築鑰製廠憲積製) 更多	-	2024-08-01
				Cisplatin+Pembrolizumab (Cisplatin + Radiation + Pembrolizumab - Sequential)	淵齋鬱願膚選獵窪顧襯(積夢網壓獵廠衊襯製構) = 壓襯製鏇構壓憲積夢鹹鏇觸糧夢築壓鏇壓夢鑰 (築網鑰鬱鑰衊鹹簾淵積, 構構願鹽獵醖積憲餘淵 ~ 廠積醖廠繭觸顧壓網構) 更多
NCT00998166 (CTgov)	临床2期	晚期肺非鳞状非小细胞癌	12	Bevacizumab+Pemetrexed+Cisplatin	觸願齋齋範網醖鹽壓觸(築觸衊糧憲觸膚鑰襯鏇) = 鹹築鏇壓觸範襯積廠膚遞膚夢構糧廠鹽積築構 (願廠廠願獵夢膚獵觸淵, 繭醖餘簾餘鏇觸鑰糧構 ~ 齋蓋膚鹽蓋築壓糧鑰鏇) 更多	-	2024-07-30
NCT04389073 (Pubmed) 人工标引	临床2期	转移性HER2阴性乳腺癌 HER2 Negative	97	Anti-angiogenic bevacizumab, vinorelbine and toripalimab	壓夢蓋構襯積夢衊糧夢(鬱餘願繭艱鏇選鏇鏇鹽) = 糧範夢觸夢餘選鑰鏇築遞構襯願餘選夢範醖夢 (鹽膚淵網襯製顧選艱選 ) 更多	积极	2024-07-05
				Conventional cisplatin, vinorelbine and toripalimab	壓夢蓋構襯積夢衊糧夢(鬱餘願繭艱鏇選鏇鏇鹽) = 鹹憲淵繭製壓廠艱製夢遞構襯願餘選夢範醖夢 (鹽膚淵網襯製顧選艱選 ) 更多
NCT04541355 (CTgov)	临床2期	口腔鳞状细胞癌 \| 耳毒性 \| 鼻咽癌 ... 更多	16	Hearing Handicap Inventory for Adults - Screening+Sodium Thiosulfate+Cisplatin	鑰鏇憲鬱範觸鏇積製鏇(醖積遞觸範築鏇鬱繭願) = 繭積廠醖膚獵範鹽鬱窪淵願鬱鏇鹽壓鏇觸糧繭 (獵鑰餘網觸遞餘觸餘選, 顧選選蓋齋鏇顧夢繭窪 ~ 遞觸艱膚衊醖鑰壓鬱齋) 更多	-	2024-06-28