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标题: 皮下注射的PD-L1抗体ASC22（Envafolimab）在IIa期HBV研究中是安全 [打印本页]

作者: StephenW 时间: 2020-12-5 12:55 标题: 皮下注射的PD-L1抗体ASC22（Envafolimab）在IIa期HBV研究中是安全

Subcutaneously Administered PD-L1 Antibody ASC22 (Envafolimab) is Safe and Well Tolerated in Phase IIa HBV Study

Published: Dec 03, 2020

HANGZHOU and SHAOXING, China, Dec. 3, 2020 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672) announces today that Phase IIa data demonstrated that ASC22 (Envafolimab) is safe and well tolerated in chronic hepatitis B (CHB) patients and Phase IIb clinical trial has been initiated. ASC22 (Envafolimab) is a first-in-class, subcutaneously administered PD-L1 antibody. (ClinicalTrials.gov Identifier: NCT04465890).

In August this year, the Company started dosing of first HBV patient in Phase IIa single dose escalation clinical trial to explore the safety and tolerability of ASC22 (Envafolimab) in the CHB patients. The data from Phase IIa study indicated that ASC22 (Envafolimab) is safe and well tolerated in the CHB patients receiving nucleos(t)ides as the background therapy. All adverse effects were grade 1 and no grade 2 or above adverse effects were observed to date. Based on such data, the multi-dose phase IIb study initiation meeting of ASC22 (Envafolimab) was held and chaired by Professor Guiqiang Wang, MD, Principal Investigator of the Study and 11th President of Infectious Diseases Society of China, Vice-President of Chinese Society of Physicians for Infectious Diseases and Director of Centre for Liver Diseases at Peking University First Hospital.

"I am impressed with the safety and tolerability data from the Phase IIa study," said Dr. Guiqiang Wang, "It is exciting that ASC22 (Envafolimab) is entering the Phase IIb study as the first PD-L1/PD-1 antibody for CHB indication. I am looking forward to developing this first-in-class drug candidate with a novel mechanism of action as an immunotherapy, which has the potential to clinically cure CHB and offers convenient subcutaneous injections for patients."

"We are excited about initiation of this Phase IIb trial in CHB patients," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "As a first-in-class immunotherapy to clinically cure CHB, ASC22 (Envafolimab) 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."

"Therapeutic activity has been demonstrated for Envafolimab (KN035) in multiple oncology indication along with strong safety profile emerging from more than 1000 patient exposure. Although tremendous progress in HBV treatment has been made recently, we are still in uphill battle to cure this disease," said Dr. Ting Xu, Chairman of Alphamab. "Because of its superior safety, convenience and compliance, we are confident that KN035, as a first SubQ PD-L1 antibody, will offer a viable option for CHB patients."

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 CHB. There are 257 million people worldwide, including 70 million people in China, infected by HBV.

About ASC22

ASC22, also known as KN035 or Envafolimab, exclusively 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. 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 has submitted a new drug application for MSI-H solid tumors.

作者: StephenW 时间: 2020-12-5 12:55

皮下注射的PD-L1抗体ASC22（Envafolimab）在IIa期HBV研究中是安全且耐受性良好的

发布时间：2020年12月3日

2020年12月3日，中国杭州和绍兴/美通社/-Ascletis Pharma Inc.（HKEX：1672）今天宣布，IIa期数据表明，ASC22（Envafolimab）在慢性乙型肝炎（CHB）患者中安全且耐受性良好IIb期临床试验已经启动。 ASC22（Envafolimab）是同类第一的皮下注射PD-L1抗体。（ClinicalTrials.gov标识符：NCT04465890）。

今年8月，公司开始在IIa期单剂量递增临床试验中对首位HBV患者进行给药，以探讨ASC22（Envafolimab）在CHB患者中的安全性和耐受性。 IIa期研究的数据表明，ASC22（Envafolimab）在接受核苷类药物作为背景治疗的CHB患者中是安全且耐受性良好的。迄今为止，所有不良反应均为1级，并且未观察到2级以上的不良反应。基于这些数据，ASC22（Envafolimab）的多剂量IIb期研究启动会议由该研究的首席研究员，中国传染病学会第11届主席，中国副主席王贵强教授主持并主持北京大学第一医院传染病医师学会和肝病研究中心主任。

王贵强博士说：“ IIa期研究的安全性和耐受性数据给我留下了深刻的印象，令人兴奋的是，ASC22（Envafolimab）作为II-b1 / PD-1抗体的第一项进入IIb期研究。 CHB适应症。我期待开发出具有新颖作用机制的此类候选药物，作为一种免疫疗法，具有临床治疗CHB的潜力，并为患者提供方便的皮下注射。”

Ascletis创始人，董事长兼首席执行官Jinzi J. Wu博士说：“我们为在CHB患者中启动IIb期临床试验感到高兴。 “ ASC22（Envafolimab）作为临床上可治愈CHB的一流免疫疗法，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候选药物以及潜在与其他行业领导者的候选药物联合使用。 ”

“ Envafolimab（KN035）在多种肿瘤学适应症中已证明具有治疗活性，并且从超过1000名患者暴露中获得了强大的安全性。尽管最近在HBV治疗方面取得了巨大进展，但我们仍在艰苦的治疗该病的斗争中， ” Alphamab主席许挺博士说。 “由于其优越的安全性，便利性和顺应性，我们有信心KN035作为首个SubQ PD-L1抗体将为CHB患者提供可行的选择。”

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CHB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。

关于ASC22

ASC22，也称为KN035或Envafolimab，是Ascletis从Alphamab独家获得的用于所有病毒适应症的抗体，是一种PD-L1单域抗体Fc融合体，具有皮下注射和在室温下良好稳定性的优点。这些对于改善患者的依从性和生活质量将具有重要价值。 Ascletis和苏州阿尔法玛有限公司于2019年1月14日宣布了抗PD-L1的战略合作和许可协议，以治疗乙型肝炎和其他病毒性疾病。 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已提交了针对MSI-H实体瘤的新药申请。

作者: newchinabok 时间: 2020-12-5 13:06

本帖最后由 newchinabok 于 2020-12-5 13:08 编辑

不太看好，有点辅助作用都算超预期了。治疗性疫苗很平庸。最后只剩下apg1378和vir公司试验了。如果还很平庸，那乙肝功能性治愈，10，20年都莫指望了

作者: sky8989 时间: 2020-12-6 11:08

newchinabok 发表于 2020-12-5 13:06
不太看好，有点辅助作用都算超预期了。治疗性疫苗很平庸。最后只剩下apg1378和vir公司试验了。如果还很平庸 ...

10年20年??请关注纳米机器人的发展，20年的时间也许会打破你的认知

作者: newchinabok 时间: 2020-12-6 15:17

本帖最后由 newchinabok 于 2020-12-6 15:23 编辑

sky8989 发表于 2020-12-6 11:08
10年20年??请关注纳米机器人的发展，20年的时间也许会打破你的认知

hbv在人体基因上，是不是纳米机器人在基因上把它们一个个摘苹果样摘下来？你比我牛十倍。你比凡尔纳还牛逼，我被你的思维惊了。你是真正的妄人，你还有什么不敢想的。

作者: 乙肝人1949 时间: 2020-12-6 19:45

知道可能不可以，也假装可以

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