An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-3)

This is an open-label, dose escalation, multi-center, Phase I/II clinical trial aimed at assessing the safety and preliminary efficacy of an investigational ARTEMIS® ECT204 T-cell therapy. The trial is suitable for adult subjects (≥ 18 years of age) diagnosed with GPC3-positive HCC, who have failed or not tolerated at least two (2) different anti-HCC systemic agents.
Phase I has concluded and a Recommended Phase II Dose (RP2D) has been determined. We are now conducting Phase II to further confirm the safety profile of ECT204 and evaluate its efficacy.

开始日期2022-03-11

申办/合作机构

Eureka Therapeutics, Inc.

100 项与 ECT-204 相关的临床结果

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100 项与 ECT-204 相关的转化医学

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100 项与 ECT-204 相关的专利（医药）

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项与 ECT-204 相关的新闻（医药）

2024-03-23

·药明康德

一次治疗10年有效的基因疗法获FDA批准，优瑞科生物肝癌T细胞疗法进入2期临床… | CGT周报

▎药明康德内容团队编辑近期，全球细胞和基因疗法（CGT）领域迎来系列进展。Orchard Therapeutics开发的基因疗法Lenmeldy获得美国FDA批准上市，治疗异染性脑白质营养不良（MLD）儿童患者。这是FDA批准治疗这一罕见遗传病的首款基因疗法。Capstan Therapeutics宣布成功完成了1.75亿美元的B轮融资，该公司的技术平台可直接在患者体内制造CAR-T细胞，用于治疗自身免疫性疾病。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。图片来源：123RF———✦研发进展✦———◇日前，美国FDA批准了由Orchard Therapeutics所开发的基因疗法Lenmeldy（atidarsagene autotemcel）用于治疗满足特定条件的的异染性脑白质营养不良儿童患者。Atidarsagene autotemcel（又名OTL-200）使用慢病毒载体将编码芳基硫酸酯酶-A的ARSA转基因导入到MLD患者的自体CD34阳性造血干细胞和祖细胞中，以恢复芳基硫酸酯酶-A的表达，从而通过一次性治疗，持续保留患者的运动功能和认知发育能力。FDA的批准是基于两项前瞻性非随机临床研究以及同情用药情况下接受治疗患者的表现。此前公布的临床试验结果显示，与疾病自然史相比，Libmeldy治疗可使大多数患者的运动功能和认知发育得以保留，患者最长随访时间达12年。▲Libmeldy试验结果（图片来源：Orchard Therapeutics公司官网）去年10月，Kyowa Kirin和Orchard Therapeutics宣布，两家公司达成最终协议，根据该协议，Kyowa Kirin将以大约3.874亿美元收购Orchard公司。此交易为atidarsagene autotemcel的开发提供了更多资源。◇百时美施贵宝宣布，CAR-T疗法Abecma（idecabtagene vicleucel）获得欧盟委员会批准，用于治疗复发/难治性多发性骨髓瘤，这些患者此前至少接受过两种治疗，包括免疫调节剂（IMiD），蛋白酶体抑制剂，或抗CD38抗体，并且出现疾病进展。这一批准是基于关键性3期临床试验KarMMa-3的研究结果，在中位随访时间为18.6个月时，Abecma显著改善了患者的无进展生存期（PFS），Abecma组的PFS为13.8个月，标准治疗组为4.4个月。意味着Abecma将患者疾病进展或死亡风险降低了51%。Abecma是一款靶向B细胞成熟抗原（BCMA）的CAR-T疗法，由百时美施贵宝和2seventy bio联合开发。◇优瑞科生物（Eureka Therapeutics）公司宣布，其靶向GPC3的T细胞疗法ECT204的临床试验ARYA-3进入2期临床阶段，用于治疗GPC3阳性肝细胞癌患者。GPC3是治疗肝细胞癌的潜力靶点，在超过70%的肝细胞癌细胞上表达。ECT204是基于该公司专有的ARTEMIS技术平台生成的T细胞疗法，此前的研究显示，这一平台与CAR-T细胞技术相比，可能带来更好的肿瘤浸润、安全性和T细胞持久性。◇GenSight Biologics日前宣布了其基因疗法Lumevoq（lenadogene nolparvovec）在3期临床试验 REFLECT中的长期疗效和安全性结果。试验结果显示，遗传性视神经病变（LHON）患者在接受Lumevoq的双侧玻璃体注射后4年，患者双眼视力与基线相较表现出持续、显著的视力改善。73%的患者视力维持具有临床意义的改善。LHON是一种罕见的遗传性疾病，主要由线粒体基因突变引起，会导致不可逆转的永久性视力丧失。95%的LHON患者携带的基因突变出现在ND1，ND4和ND6基因上，而ND4基因突变是导致大多数LHON病例的原因。Lumevoq是一种利用AAV2载体递送正常人类线粒体ND4基因的基因疗法，而且AAV2载体携带的ND4基因带有特定线粒体靶向序列（MTS），可以促进蛋白在线粒体中的表达。◇神曦生物（NeuExcell Therapeutics）公司宣布，在研基因疗法NXL-004完成了首例患者给药，受试者为复发性脑胶质瘤患者，手术及给药过程顺利，患者术后状况平稳，未见明显不良反应，恢复良好，术后1周顺利出院。NXL-004是基于神曦生物创始人陈功教授团队开创性的原位转分化技术平台而开发的创新治疗方法，也是首款获得FDA孤儿药资格认定的针对恶性胶质瘤的AAV基因治疗产品。其工作原理是在胶质瘤细胞里过表达神经转录因子NeuroD1，抑制肿瘤细胞的分裂增殖，同时推动其向神经细胞的转分化。与放化疗相比，NeuroD1基因疗法从肿瘤细胞内部起作用，改变其基因表达的转录组，对周围组织或其他器官的细胞副作用较小。———✦融资和合作✦———◇Capstan Therapeutics宣布成功完成了1.75亿美元的超额认购B轮融资。B轮融资所获得的资金将用于推进Capstan的主打体内CAR-T候选疗法CPTX2309在自身免疫性疾病中的早期临床概念验证，并进一步开发Capstan的靶向脂质纳米颗粒（tLNP）管线。CPTX2309是Capstan公司tLNP平台的产物，它将编码靶向CD19的嵌合抗原受体的mRNA载荷递送到表达CD8的T细胞中，从而有效地在体内直接生成CAR-T细胞疗法。这种方法的目标是通过在血液和淋巴组织中快速深度清除B细胞，实现免疫系统的重置，并且避免传统体外生产CAR-T细胞疗法的挑战。▲Laura Shawver博士在2023药明康德全球论坛上分享基因和细胞疗法开发的洞见在2023药明康德全球论坛上，Capstan公司的首席执行官Laura Shawver博士表示，在基因疗法领域，业界已经意识到病毒载体的局限性，因此包括LNP在内的非病毒载体将在未来的基因疗法开发中拥有一席之地。对于LNP载体技术来说，如何特异性地将LNP递送到不同类型的细胞中是需要解决的问题。Capstan公司的tLNP技术平台通过在LNP上装饰与特定受体相结合的抗体或抗体片段，有望解决特异性递送的难题。大家都在看作为药明康德旗下专注于细胞和基因疗法的CTDMO，药明生基致力于加速和变革基因和细胞治疗及其他高端治疗的开发、测试、生产和商业化。药明生基能够助力全球客户将更多创新疗法早日推向市场，造福病患。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] NeuExcell Therapeutics Announces Successful Dosing of First Patient by NeuroD1 Gene Therapy. Retrieved March 22, 2024, from https://www.prnewswire.com/news-releases/neuexcell-therapeutics-announces-successful-dosing-of-first-patient-by-neurod1-gene-therapy-302096579.html[2] GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ® Injections Four Years After One-Time Administration. Retrieved March 22, 2024, from https://www.businesswire.com/news/home/20240319984906/en[3] Orchard Therapeutics Receives FDA Approval of Lenmeldy™ (atidarsagene autotemcel), the Only Therapy for Eligible Children with Early-onset Metachromatic Leukodystrophy in the U.S. Retrieved March 22, 2024, from https://www.globenewswire.com/news-release/2024/03/18/2848132/0/en/Orchard-Therapeutics-Receives-FDA-Approval-of-Lenmeldy-atidarsagene-autotemcel-the-Only-Therapy-for-Eligible-Children-with-Early-onset-Metachromatic-Leukodystrophy-in-the-U-S.html[4] Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) Becomes First CAR T Cell Therapy Approved in the European Union in Earlier Lines for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma. Retrieved March 22, 2024, from https://www.businesswire.com/news/home/20240320035615/en[5] 'Cell therapy without cells': Capstan raises $175M to test in vivo CAR-T. Retrieved March 22, 2024, from https://endpts.com/cell-therapy-without-cells-capstan-raises-175m-to-test-in-vivo-car-t/[6] Eureka Therapeutics Advances ARYA-3 Clinical Trial to Phase II for Treatment of Liver Cancer Using GPC3-Targeting ARTEMIS® T-cell Therapy. Retrieved March 22, 2024, from https://www.businesswire.com/news/home/20240318314692/en免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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：本文来自药明康德内容团队，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

细胞疗法免疫疗法临床2期基因疗法上市批准

2023-03-14

·BioSpace

Eureka Therapeutics Licenses Promising Antibody Targeting Mesothelin from the National Cancer Institute

EMERYVILLE, Calif.--(BUSINESS WIRE)-- Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat cancer, today announced it has entered into a license agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, to develop and commercialize a novel antibody targeting mesothelin (MSLN) in combination with Eureka’s proprietary ARTEMIS® T-cell receptor platform. MSLN is a cell-surface protein overexpressed in many solid tumors, including mesothelioma, ovarian, pancreatic, breast and lung cancers, making it a promising target for cancer therapies. The NCI antibody licensed to Eureka has shown potential in preclinical studies to selectively bind to and kill cancer cells expressing MSLN while sparing normal cells, which could make it an effective cancer treatment. Eureka has previously demonstrated that its proprietary ARTEMIS T-cell receptor platform has several advantages over conventional chimeric antigen receptors (CARs), including better tumor infiltration, safety, and T cell persistence. By combining the newly licensed MSLN-targeting antibody with the ARTEMIS T-cell receptor platform, Eureka and NCI intend to develop a next-generation T-cell therapy that can effectively target and eliminate MSLN-expressing cancer cells. “We are excited to add this promising antibody to our ARTEMIS receptor portfolio and to advance the development of a potentially transformative T-cell therapy for solid tumors,” said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. “Our goal is to develop safe and effective T-cell therapies to treat MSLN-expressing cancers. We believe the combination of our ARTEMIS platform and this novel antibody targeting MSLN is a promising approach to achieve this goal.” “The license of NCI’s MSLN-targeting antibody highlights our commitment to advancing promising cancer therapies,” said Dr. Ira Pastan, Chief Emeritus of the Laboratory of Molecular Biology and Head of the Molecular Biology Section at the NCI Center for Cancer Research. “Such partnerships have the potential to bring transformative therapies to patients.” Eureka plans to continue preclinical development of the antibody to support an investigational new drug (IND) application with the US Food and Drug Administration (FDA). ABOUT EUREKA THERAPEUTICS, INC. Eureka Therapeutics, Inc. is a privately held clinical-stage biotechnology company focused on developing novel T-cell therapies to treat cancers. Its core technology centers around its proprietary ARTEMIS® cell receptor platform and E-ALPHA® antibody discovery platform for the discovery and development of potentially safer and more effective T-cell therapies for the treatment of solid tumors and hematologic malignancies. The company currently has two clinical programs, ET140203 (ARYA1 for adults and ARYA2 for pediatrics) and ECT204 (ARYA3), in Phase I/II US trials in patients with advanced liver cancer. Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information on Eureka, please visit . ARTEMIS and E-ALPHA are registered trademarks owned by Eureka.

引进/卖出细胞疗法临床研究免疫疗法

2022-10-18

·eurekatherapeutics

Eureka Therapeutics Announces License with the National Cancer Institute to Advance GPC2 ARTEMIS® T Cell Therapy for Neuroblastoma - Eureka

Emeryville, California, October 18, 2022 – Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat cancer, today announced it has entered into a license agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, for a glypican 2 (GPC2) binding domain to be used for the potential development and commercialization of ARTEMIS® T cell therapies for patients with neuroblastoma, a rare cancer that affects the developing nervous system. The therapy also has expansion potential in medulloblastoma and small cell lung cancer, among several other pediatric and adult cancers that express an abundance of the GPC2 protein on their cell surface. Neuroblastoma is a rare cancer that affects the development of the nervous system by attacking immature nerve cells as early as the embryonic stage. Each year, about 800 children are diagnosed with neuroblastoma in the U.S., and overall survival rates are lower than 50%. Current chemotherapy options for these patients are limited and highly toxic, which highlights the urgent need for new treatments for this disease to improve overall survival and reduce long-term toxicity. “GPC2 is an exciting new target for neuroblastoma. In pre-clinical models, anti-GPC2 directed ARTEMIS T cells demonstrated significant tumor-killing activity,” said Dr. Mitchell Ho, Deputy Chief of the Laboratory of Molecular Biology and Director of the Antibody Engineering Program at the NCI Center for Cancer Research. “We believe it is beneficial to further evaluate anti-GPC2 directed ARTEMIS T cells as a potential T cell therapy for patients with neuroblastoma and other cancers that express GPC2.” “The expansion of our pipeline with an anti-GPC2 program supports our effort to deliver the potential benefit of ARTEMIS T cell therapies for patients with neuroblastoma. As the field of T cell therapy continues its rapid advancement, we remain committed to pioneering the next generation of T cell therapies.” said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics. ABOUT EUREKA THERAPEUTICS, INC. Eureka Therapeutics, Inc. is a privately held clinical-stage biotechnology company focused on developing novel T cell therapies to treat cancers. Its core technology centers around its proprietary ARTEMIS® cell receptor platform and E-ALPHA® antibody discovery platform for the discovery and development of potentially safer and more effective T cell therapies for the treatment of solid tumors and hematologic malignancies. The company currently has two clinical programs, ET140203 (ARYA1 for adults and ARYA2 for pediatrics) and ECT204 (ARYA3), in Phase I/II US trials in patients with advanced liver cancer. Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information on Eureka, please visit www.eurekatherapeutics.com. ARTEMIS and E-ALPHA are registered trademarks owned by Eureka. CONTACTS: Eureka Therapeutics, Inc. Natalie Liu Investor Relations 510-318-9215 IR@eurekainc.com

细胞疗法引进/卖出临床研究

100 项与 ECT-204 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期肝细胞癌	临床2期	美国	Eureka Therapeutics, Inc.	2022-03-11
晚期肝细胞癌	临床2期	中国台湾	Eureka Therapeutics, Inc.	2022-03-11
肝转移	临床2期	美国	Eureka Therapeutics, Inc.	2022-03-11
肝转移	临床2期	中国台湾	Eureka Therapeutics, Inc.	2022-03-11