歌礼宣布 ASC22（Envafolimab）IIb 期扩展队列中首位患者的给药

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歌礼宣布 ASC22（Envafolimab）IIb 期扩展队列中首位患者的给药剂量，用于慢性乙型肝炎功能性治愈

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歌礼制药公司

美国东部时间 2022 年 9 月 27 日 20:10
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——2022年6月与中国国家药品监督管理局（NMPA）药品审评中心（CDE）三期临床试验前会议后，注册途径，包括患者人群、剂量、疗程等ASC22 (Envafolimab) 用于慢性乙型肝炎 (CHB) 的功能性治愈已获得共识

-- IIb 期扩展队列将招募 50 名基线 HBsAg ≤100 IU/mL 的 CHB 患者，他们将接受 1.0 mg/kg ASC22 或安慰剂（比例为 4:1）与 Nucleot(s)ide 类似物联合治疗(NAs) 24 周治疗加 24 周随访

-- 这项扩展队列研究的目的是确认功能性治愈率是否与欧洲肝脏研究协会举办的 2022 年国际肝脏大会 (ILC 2022) 口头会议上提供的数据相似（ EASL) 在 2022 年 6 月的研究表明，42.9% (3/7) 的基线 HBsAg ≤100 IU/mL 的患者获得了功能性治愈。预计2023年初完成50名慢性乙型肝炎患者的入组

杭州和中国绍兴，2022 年 9 月 27 日 /美通社/ -- Ascletis Pharma Inc.（HKEX:1672，“Ascletis”）今天宣布，该公司的 IIb 期扩展队列（“扩展队列”）中的第一位患者给药皮下给药 PD-L1 抗体 ASC22 (Envafolimab) 用于慢性乙型肝炎 (CHB) 的功能性治愈。

2022年6月与中国国家药品监督管理局（NMPA）药品审评中心（CDE）三期临床试验前会议后，ASC22的注册途径，包括患者人群、剂量、疗程等（ Envafolimab) 用于慢性乙型肝炎的功能性治愈已被同意。

扩展队列将招募 50 名基线乙型肝炎表面抗原 (HBsAg) ≤100 IU/mL 的慢性乙型肝炎患者，他们将接受 1.0 mg/kg ASC22 或安慰剂（比例为 4:1）与 Nucleot 联合治疗ide 类似物 (NAs) 用于 24 周治疗和 24 周随访。目的是确认 ASC22 的功能治愈率是否与 2022 年 6 月欧洲肝脏研究协会 (EASL) 举行的国际肝脏大会™ 2022 (ILC 2022) 口头会议上提供的数据相似，结果表明，基线 HBsAg≤100 IU/mL 的患者中有 42.9%（3/7）获得了功能性治愈。扩展队列的 50 名 CHB 患者的入组预计将于 2023 年初完成。

在扩展队列启动之前，歌礼已在中国完成了一项随机、单盲、安慰剂对照和多中心的 IIb 期临床试验，评估了对 149 名慢性乙型肝炎患者进行 24 周治疗加24 周随访 1 mg/kg 或 2.5 mg/kg ASC22 或匹配安慰剂每两周一次 (Q2W) 与 NAs 联合给药 (ClinicalTrials.gov: NCT04465890)。

CHB 在全球范围内仍然是一项未得到满足的医疗需求，中国约有 8600 万人和美国有 159 万人感染了乙型肝炎病毒 (HBV) [1]。 NAs仅抑制HBV RNA逆转录为HBV DNA，不抑制HBV cccDNA转录为HBV RNA，因此对HBsAg无抑制作用。

ASC22 (Envafolimab) 是世界上最先进的临床阶段免疫疗法，用于通过阻断 PD-1/PD-L1 通路来治疗慢性乙型肝炎功能性治愈，即 HBsAg 丢失。歌礼在 2022 年 6 月的 EASL ILC 2022 口头会议上公布了 ASC22 在慢性乙型肝炎患者中的最新 IIb 期临床试验结果，显示基线 HBsAg≤100 IU/mL 的患者中有 42.9%（3/7）获得了持续的 HBsAg 下降和自上次 ASC22 (Envafolimab) 给药后至今未出现反弹，表明慢性乙型肝炎有潜在的功能性治愈。对于肿瘤适应症，Envafolimab已于2021年11月获得中国国家药监局批准用于治疗成人不可切除或转移性微卫星不稳定性高（MSI-H）或错配修复缺陷（dMMR）晚期实体瘤。

“我们对过去几个月 ASC22（Envafolimab）在 CHB 功能性治愈方面取得的令人兴奋的进展感到非常鼓舞。ASC22（Envafolimab）从我们在 EASL ILC 2022 上展示的结果初步证明了 CHB 功能性治愈的潜力。是中国庞大的慢性乙型肝炎患者群体，基线 HBsAg≤100 IU/mL[2]。在寻求 ASC22（恩伐利单抗）作为基线 HBsAg≤100 IU/mL 慢性乙型肝炎患者的单药治疗的同时，我们也在与全球合作伙伴进行讨论针对基线 HBsAg>100 IU/mL 的患者群体进行联合治疗，以惠及更广泛的 CHB 患者群体。”歌礼创始人、董事长兼首席执行官吴金子博士说。

StephenW

Ascletis Announces Dosing of the First Patient in the Phase IIb Expansion Cohort of ASC22 (Envafolimab) for Chronic Hepatitis B Functional Cure

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Ascletis Pharma Inc.

Sep 27, 2022, 20:10 ET
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-- After the pre-Phase III clinical trial meeting with Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) in June 2022, the pathway to the registration, including patient population, dose, treatment duration, etc. of ASC22 (Envafolimab) for functional cure of chronic hepatitis B (CHB) has been agreed

-- The Phase IIb Expansion Cohort will enroll 50 CHB patients with baseline HBsAg≤100 IU/mL who will be treated with 1.0 mg/kg ASC22 or placebo (with the ratio of 4:1) in combination with Nucleot(s)ide analogues (NAs) for 24-week treatment plus 24-week follow-up

-- The objective of this Expansion Cohort study is to confirm whether the rate of functional cure is similar to the data presented at oral session of the International Liver Congress™ 2022 (ILC 2022) held by the European Association for the Study of the Liver (EASL) in June 2022, which showed that 42.9% (3/7) of patients with baseline HBsAg ≤100 IU/mL obtained functional cure. The enrollment of 50 CHB patients is expected to be completed in early 2023  

HANGZHOU and SHAOXING, China, Sept. 27, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") today announces dosing of the first patient in the Phase IIb Expansion Cohort (the "Expansion Cohort") of subcutaneously administered PD-L1 antibody ASC22 (Envafolimab) for functional cure of chronic hepatitis B (CHB).

After the pre-Phase III clinical trial meeting with Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) in June 2022, the pathway to the registration, including patient population, dose, treatment duration, etc. of ASC22 (Envafolimab) for functional cure of CHB has been agreed.

The Expansion Cohort will enroll 50 CHB patients with baseline hepatitis B surface antigen (HBsAg) ≤100 IU/mL who will be treated with 1.0 mg/kg ASC22 or placebo (with the ration of 4:1) in combination with Nucleot(s)ide analogues (NAs) for 24-week treatment plus 24-week follow-up. The objective is to confirm whether the functional cure rate of ASC22 is similar to the data presented at oral session of the International Liver Congress™ 2022 (ILC 2022) held by the European Association for the Study of the Liver (EASL) in June 2022, which showed that 42.9% (3/7) of patients with baseline HBsAg≤100 IU/mL obtained functional cure. The enrollment of 50 CHB patients of the Expansion Cohort is expected to be completed in early 2023.

Prior to the initiation of the Expansion Cohort, Ascletis has completed a randomized, single-blind, placebo-controlled and multi-center Phase IIb clinical trial in China which evaluated the safety and efficacy of treating 149 patients with CHB for 24-week treatment plus 24-week follow-up of 1 mg/kg or 2.5 mg/kg ASC22 or matching placebo given once every two weeks (Q2W) in combination with NAs (ClinicalTrials.gov: NCT04465890).

CHB remains to be a significantly unmet medical need globally, with approximately 86 million people in China and 1.59 million people in the U.S. infected with hepatitis B virus (HBV) [1]. NAs inhibit only reverse transcription of HBV RNA into HBV DNA and do not inhibit the transcription of HBV cccDNA into HBV RNA, thus have no inhibitory effect on HBsAg.

ASC22 (Envafolimab) is the most advanced clinical-stage immunotherapy in the world for CHB functional cure, i.e. HBsAg loss, through blocking PD-1/PD-L1 pathway. Ascletis presented the latest Phase IIb clinical trial results of ASC22 in patients with CHB at oral session of EASL ILC 2022 in June 2022, which showed that 42.9% (3/7) patients with baseline HBsAg≤100 IU/mL obtained sustained HBsAg loss and no rebound has occurred up to now since the last dosing of ASC22 (Envafolimab), indicating a potential functional cure of CHB. For tumor indications, Envafolimab has been approved for treatment of adults with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors by China NMPA in November 2021.

"We are very encouraged by the exciting progress which ASC22 (Envafolimab) has made for CHB functional cure during the past few months. ASC22 (Envafolimab) has preliminarily demonstrated the potential of functional cure of CHB from our results presented at EASL ILC 2022. There is a huge CHB patient population base in China with baseline HBsAg≤100 IU/mL[2]. While pursuing ASC22 (Envafolimab) as monotherapy for CHB patients with baseline HBsAg≤100 IU/mL, we are also engaging with global partners in discussion on combo therapies targeting patient population with baseline HBsAg>100 IU/mL, so as to benefit a broader spectrum of CHB patient population." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.