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在皮下注射的PD-L1抗体ASC22的IIa期临床试验中首次使用了HBV患 [复制链接]

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发表于 2020-8-17 18:26 |只看该作者 |倒序浏览 |打印
First HBV Patient Dosed in Phase IIa Clinical Trial of ASC22, a Subcutaneously Administered PD-L1 Antibody
August 17, 2020, 10:30 AM GMT+10·4 mins read

HANGZHOU, China and SHAOXING, China, Aug. 16, 2020 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) announces today dosing of the first HBV patient in Phase IIa clinical trial of ASC22, which is a first-in-class, subcutaneously administered PD-L1 antibody.

ASC22(Envafolimab) Phase IIa clinical trial is a single dose escalation study with three subcutaneously administered doses (0.3, 1.0 and 2.5 mg/kg) to explore the safety and efficacy of ASC22(Envafolimab) in chronic hepatitis B patients (ClinicalTrials.gov Identifier: NCT04465890).

As T cell exhaustion in chronic HBV infections is an important factor in immune tolerance, blocking the PD-1/PD-L1 pathway could be an effective immunotherapy approach to improve specific T cell function and lead to an effective clinical cure for chronic hepatitis B. There are 257 million people worldwide, including 70 million people in China, infected by HBV.

"We are excited about dosing the first chronic hepatitis B patient with ASC22(Envafolimab)," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "As a first-in-class immunotherapy with the potential to clinically cure chronic hepatitis B, ASC22(Envafolimab) offers convenient subcutaneous injections for patients and has potential to be a cornerstone therapy in various treatment regimens, including combinations with our in-house developed drug candidates and potentially with drug candidates from other industrial leaders."

"We are expecting the clinical results of the safety and efficacy of Envafolimab in HBV patients," said Dr. Ting Xu, Chairman of Alphamab. "Due to its unique immune mechanism, Envafolimab is likely to trigger HBV specific immune response, produce seroconversion, and bring hope of cure to patients. And it may also be used in patients with other chronic viral infections. The safety and convenience of subcutaneous administration of Envafolimab have been reflected to the greatest extent in the treatment of chronic diseases."

About ASC22

ASC22, also known as KN035 or Envafolimab, licensed from Alphamab by Ascletis for all viral indications, is a PD-L1 single domain antibody Fc fusion and has the advantages of subcutaneous injection and good stability at room temperature. These would be of great value to improve patients' compliance and quality of life and to help realize the goal of long-term management of chronic diseases such as chronic hepatitis B. Ascletis and Suzhou Alphamab Co., Ltd. announced on January 14, 2019 the strategic collaboration and licensing agreement for anti-PD-L1 to treat Hepatitis B and other viral diseases. Envafolimab has been enrolled in more than 1,000 patients and has shown good safety and efficacy in multiple tumor indications. Alphamab is preparing to submit a new drug application for MSI-H solid tumors.

About Alphamab

Suzhou Alphamab Co., Ltd., focused on research and development of mAbs, fusion proteins and other biological macromolecule drugs. With multiple proprietary platforms in antibody screening, protein engineering, CMC development and pilot production set up in its 6000m2 laboratory in bioBAY Suzhou, Alphamab has created a robust pipeline of over 50 promgrams, of which 20+ are innovative. Alphamab aims to develop affordable and efficient biological drugs to address high unmet medical needs globally.

About Ascletis

Ascletis is an innovative R&D driven biotech with three commercial products and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing antiviral, steatohepatitis, and tumor-related innovative drugs for unmet medical needs in China and Globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis' pipeline is focused primarily on three therapeutic areas: 1. HCV: two commercial stage products and two R&D stage drug candidates. Ganovo® (Danoprevir) is the first direct-acting anti-viral agent for hepatitis C, developed by a domestic firm in China. Asclevir® (Ravidasvir) in combination with Ganovo® (Danoprevir) (RDV/DNV Regimen) is the first all-oral HCV regimen developed by a domestic company in China. 2. HBV: one commercial stage product and three R&D stage drug candidates. Pegasys® (Peginterferon alfa-2a) is a leading marketed pegylated interferon for hepatitis B&C partnered with Roche. 3. NASH (Non-Alcoholic SteatoHepatitis): three R&D stage drug candidates against three different targets for combination treatments. For more information, please visit www.ascletis.com.

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才高八斗

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发表于 2020-8-17 18:27 |只看该作者
在皮下注射的PD-L1抗体ASC22的IIa期临床试验中首次使用了HBV患者
2020年8月17日,格林尼治标准时间10:30 + 10·4分钟

2020年8月16日,中国杭州和中国绍兴/ PRNewswire /-Ascletis Pharma Inc.(香港交易所代码:1672)今天宣布在ASC22的IIa期临床试验中对首位HBV患者进行给药,这是第一个-类,皮下注射PD-L1抗体。

ASC22(Envafolimab)IIa期临床试验是一项单剂量递增研究,采用三种皮下给药剂量(0.3、1.0和2.5 mg / kg),以探讨ASC22(Envafolimab)在慢性乙型肝炎患者中的安全性和有效性(ClinicalTrials.gov标识符) :NCT04465890)。

由于慢性HBV感染中的T细胞衰竭是免疫耐受的重要因素,因此阻断PD-1 / PD-L1途径可能是改善特异性T细胞功能并有效治愈慢性乙型肝炎的有效免疫疗法。全世界有2.57亿人感染HBV,其中包括中国的7000万人。

Ascletis创始人,董事长兼首席执行官Wu Jinzi J. Wu表示:“我们很高兴为首位ASC22(Envafolimab)慢性乙型肝炎患者服药。 “ ASC22(Envafolimab)作为具有潜力的可在临床上治愈慢性乙型肝炎的一流免疫疗法,为患者提供方便的皮下注射,并有可能成为各种治疗方案的基石疗法,包括与我们内部研发的组合候选药物,并可能与其他行业领导者的候选药物一起使用。”

Alphamab主席Ting Xu博士说:“我们期待Envafolimab在HBV患者中的安全性和有效性的临床结果。” Envafolimab凭借其独特的免疫机制,很可能触发HBV特异性免疫反应,产生血清转化,并给患者带来治愈的希望。它还可用于患有其他慢性病毒感染的患者。皮下给药的安全性和便利性Envafolimab的药物已在慢性疾病的治疗中得到最大程度的体现。”

关于ASC22

ASC22,也被称为KN035或Envafolimab,是Ascletis从Alphamab获批的所有病毒适应症,是一种PD-L1单结构域抗体Fc融合体,具有皮下注射和在室温下良好稳定性的优点。这些对于提高患者的依从性和生活质量以及实现慢性病如慢性乙型肝炎的长期管理目标具有重大价值.Ascletis和苏州阿尔法单抗有限公司于2019年1月14日宣布抗PD-L1治疗乙肝和其他病毒性疾病的战略合作和许可协议。 Envafolimab已被纳入1,000例患者,并在多种肿瘤适应症中显示出良好的安全性和有效性。 Alphamab正准备提交针对MSI-H实体瘤的新药申请。

关于阿尔法单抗

苏州阿尔法玛有限公司专注于单克隆抗体,融合蛋白和其他生物大分子药物的研发。 Alphamab在其位于苏州bioBAY的6000平方米实验室中建立了抗体筛选,蛋白质工程,CMC开发和试生产的多个专有平台,已创建了一个功能强大的管道,包含50多个程序图,其中20多个具有创新性。 Alphamab旨在开发负担得起的高效生物药物,以满足全球尚未满足的高度医疗需求。

关于Ascletis

Ascletis是一家创新研发驱动的生物技术,具有三种商业产品,并在香港联合交易所上市(Ascletis,1672.HK)。 Ascletis致力于在中国和全球范围内满足未满足的医疗需求的抗病毒,脂肪性肝炎和肿瘤相关创新药物的开发和商业化。在拥有深厚专业知识和成功经验的管理团队的带领下,Ascletis已发展成为一个完全集成的平台,涵盖了从发现,开发到制造和商业化的整个价值链。 Ascletis的产品线主要集中在三个治疗领域:1。 HCV:两种商业阶段产品和两种研发阶段候选药物。 Ganovo®(Danoprevir)是首家由中国国内公司开发的丙型肝炎直接作用抗病毒药。 Asclevir®(Ravidasvir)与Ganovo®(Danoprevir)(RDV / DNV Regimen)联合使用是中国国内公司开发的第一种全口服HCV疗法。 2.乙肝病毒:一种商业阶段的产品和三种研发阶段的候选药物。 Pegasys®(Peginterferon alfa-2a)是与罗氏(Roche)合作的用于B&C肝炎的聚乙二醇化干扰素。 3. NASH(非酒精性脂肪性肝炎):针对三个不同靶点的三种R&D阶段候选药物进行联合治疗。有关更多信息,请访问www.ascletis.com

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发表于 2020-8-17 19:47 |只看该作者
apg1387,asc22,vir3434(单克隆抗体),治疗性疫苗,toll7,toll8都是明年看点

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发表于 2020-8-17 22:48 |只看该作者
看了那篇巴斯德实验室的文章,克隆抗体应该非常有前途

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发表于 2020-8-17 23:14 |只看该作者
windu 发表于 2020-8-17 22:48
看了那篇巴斯德实验室的文章,克隆抗体应该非常有前途

能不能发个链接,我看哈

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发表于 2020-8-17 23:28 |只看该作者
回复 newchinabok 的帖子

肝脏时间公众号8月14号的文章,你应该看过了吧

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发表于 2020-8-17 23:37 |只看该作者
windu 发表于 2020-8-17 23:28
回复 newchinabok 的帖子

肝脏时间公众号8月14号的文章,你应该看过了吧

我看的和我发的绝大多数瞟一眼,懒得研究,哈哈。所有信息都早得很

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发表于 2020-8-17 23:53 |只看该作者
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