[Translation] A multicenter, randomized, controlled, open-label phase III study to evaluate the efficacy and safety of recombinant humanized monoclonal antibody MIL62 injection in the treatment of primary membranous nephropathy

1. 评价和比较MIL62 和环孢素治疗原发性膜性肾病受试者52 周的总体缓解率（ORR）； 2. 评价和比较MIL62 和环孢素治疗原发性膜性肾病受试者76 周的ORR。

[Translation]

1. To evaluate and compare the overall response rate (ORR) of MIL62 and cyclosporine in the treatment of primary MN subjects at 52 weeks; 2. To evaluate and compare the ORR of MIL62 and cyclosporine in the treatment of primary MN subjects at 76 weeks.

Start Date02 Jun 2023

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

NCT05862233 / RecruitingPhase 3

A Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of MIL62 Injection in Participants With Primary Membranous Nephropathy

This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).

Start Date02 Jun 2023

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

CTR20230336 / RecruitingPhase 2/3

一项评价重组人源化单克隆抗体MIL62 注射液治疗系统性红斑狼疮的有效性和安全性的多中心、随机、双盲、Ⅱ/Ⅲ期临床研究

[Translation] A multicenter, randomized, double-blind, phase II/III clinical study to evaluate the efficacy and safety of recombinant humanized monoclonal antibody MIL62 injection in the treatment of systemic lupus erythematosus

主要目的：评价MIL62 在系统性红斑狼疮患者中的有效性（SRI-4 评分自基线的变化）。

[Translation]

Primary objective: To evaluate the effectiveness of MIL62 in patients with systemic lupus erythematosus (change from baseline in SRI-4 score).

Start Date26 May 2023

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

100 Clinical Results associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

100 Translational Medicine associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

100 Patents (Medical) associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

Literatures (Medical) associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

01 Jul 2024·eClinicalMedicine

Efficacy and safety of MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial

Article

Author: Jing, Hongmei ; Wang, Zhao ; Zang, Aimin ; Wang, Zhen ; Wei, Min ; Li, Zhenyu ; Zhou, Keshu ; Liang, Jinjin ; Zhou, Hui ; Song, Yongping ; Zhang, Huilai ; Qin, Yan ; Xiang, Ying ; Shi, Yuankai ; Bai, Ou

BackgroundMIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, with a nearly completely afucosylated N-glycans in Fc region, has demonstrated superior activity compared with rituximab and obinutuzumab in vitro and in vivo, respectively.MethodsThis multicentre, single-arm, phase 1b/2 trial aimed to explore the efficacy, pharmacokinetics, and safety of MIL62 combined with lenalidomide in patients with relapsed/refractory (R/R) follicular lymphoma (FL) or marginal zone lymphoma (MZL). Eligible patients included those who had histopathologically confirmed CD20 positive FL (grade 1-3a) or MZL and failed to be treated with rituximab. Patients received intravenously infused MIL62 1000 mg (cycle 1: day 1, 15; cycles 2-8: day 1, cycles 10 and 12: day 1) combined with oral lenalidomide (once a day, days 2-22, the initial dose was 10 mg, and the maximum dose was 20 mg) for 12 cycles, 28 days as a cycle. The primary endpoint was objective response rate (ORR) assessed by investigator per Lugano 2014 criteria every 3 cycles. This study was registered in ClinicalTrials.gov (NCT04110301).FindingsBetween November 22, 2019 and December 22, 2020, 54 patients were enrolled from 11 hospitals in China and received study treatment. Fifty patients were included in the efficacy analysis set, and 43 patients (86%, 95% CI: 73, 94) achieved objective response, meeting the pre-specified primary endpoint. Disease control rate was 96% (48/50, 95% CI: 86, 100), proportion of patients with duration of response (DoR) > 6 months was 77% (33/43). The median follow-up for survival was 12.3 months (IQR 12.0-12.6). The 1-year progression-free survival rate was 72% (95% CI: 57, 83), 9-month DoR rate was 74% (95% CI: 58, 85), and 1-year overall survival rate was 98% (95% CI: 85, 100). Most common TRAEs were neutropenia (93%, 50/54), leukopenia (85% 46/54), thrombocytopenia (61% 33/54), lymphopenia (32% 17/54), and alanine aminotransferase increased (20% 11/54).InterpretationMIL62 combined with lenalidomide showed promising efficacy in patients with R/R FL and MZL. A multicentre, randomized, open-label, phase Ⅲ trial of MIL62 combined with lenalidomide versus lenalidomide in anti-CD20 monoclonal antibody refractory FL patients is ongoing (NCT04834024).FundingBeijing Mabworks Biotech Co. Ltd, Beijing China and the National Science and Technology Major Project for Key New Drug Development (2017ZX09304015).

100 Deals associated with Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Membranous Glomerulonephritis	Phase 3	CN	Beijing Mabworks Biotech Co., Ltd.	02 Jun 2023
Systemic Lupus Erythematosus	Phase 3	CN	Beijing Mabworks Biotech Co., Ltd.	26 May 2023
Neuromyelitis Optica	Phase 3	CN	Beijing Mabworks Biotech Co., Ltd.	18 Aug 2022
Refractory Follicular Lymphoma	Phase 3	CN	Beijing Mabworks Biotech Co., Ltd.	02 Jun 2021
B-cell lymphoma recurrent	Phase 2	CN	Beijing InnoCare Pharma Tech Co., Ltd.	28 Jul 2020
B-cell lymphoma refractory	Phase 2	CN	Beijing InnoCare Pharma Tech Co., Ltd.	28 Jul 2020
CD20 positive B-Cell Lymphoma	Phase 2	CN	Beijing InnoCare Pharma Tech Co., Ltd.	28 Jul 2020
Refractory Indolent Non-Hodgkin Lymphoma	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	28 Nov 2019
Myasthenia Gravis	Discovery	CN	Beijing Mabworks Biotech Co., Ltd.	27 Sep 2021
Marginal zone lymphoma refractory	Discovery	CN	Beijing Mabworks Biotech Co., Ltd.	02 Jun 2021

Clinical Result

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Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05398653 (NEWS) Manual	Phase 1/2	Glomerulonephritis, Membranous	-	MIL62	(arxeyoepsu) = zsisqiyuzv acoflukqyg (nfrrkmkqnj ) View more	Positive	23 Oct 2024
NCT05398653 (NEWS) Manual	Phase 1/2	Glomerulonephritis, Membranous	-	Cyclosporine	(arxeyoepsu) = xcldtspoxa acoflukqyg (nfrrkmkqnj ) View more	Positive	23 Oct 2024
NCT04110301 (Pubmed) Manual	Phase 1/2	Follicular Lymphoma \| Marginal Zone B-Cell Lymphoma	50	MIL62 + Lenalidomide	(jlcvehyopw) = pwdalbxank hwqjgeholj (rdisiyadkd, 73 - 94) View more	Positive	01 Jul 2024
NCT05398653 (#3776, ERA2023)	Phase 1/2	Idiopathic Membranous Glomerulonephritis First line anti-PLA2R antibodies	85	MIL62 600 mg	(vsviwghfec) = occurred in 16.7%, 0.0% and 8.0% of patients in the MIL62 600 mg, MIL62 1000 mg and Cyclosporine group respectively oflmashjbn (uycbqiuniv ) View more	Positive	14 Jun 2023
NCT05398653 (#3776, ERA2023)	Phase 1/2		85	MIL62 1000 mg		Positive	14 Jun 2023
NCT04304040 (ASH2022) Manual	Phase 1/2	B-cell lymphoma refractory	43	Orelabrutinib+MIL62	(tznmfuotan) = tsuypfhecl suuzpmpdzu (rtvbljzwcx ) View more	Positive	12 Dec 2022
CSCO2022	Phase 1/2	B-Cell Lymphoma	43	MIL62 注射液	wabrwqvpnu(mmtzrmlhyi) = MIL62输液反应发生率为11.6%, 均为 1-2级 djuhjmiooj (gyxeqhrmeg ) View more	-	21 Sep 2022
NCT04110301 (ASH2021) Manual	Phase 1/2	Refractory Follicular Lymphoma \| Marginal Zone B-Cell Lymphoma	54	Lenalidomide+MIL62	(waombxfpum) = mwkbswvrwo ftosbyynxz (baqkdwjbww ) View more	Positive	05 Nov 2021
NCT04110301 (ASH2021) Manual	Phase 1/2		54	refractory to rituximab	(waombxfpum) = zeazxjxqyy ftosbyynxz (baqkdwjbww ) View more	Positive	05 Nov 2021
NCT04304040 (ESMO2021) Manual	Phase 1/2	B-cell lymphoma refractory CD20 Positive	14	Orelabrutinib+MIL62	(euqaduhsgm) = thrombocytopenia (5/14, 35.7%), infusion-related reaction (3/14, 21.4%) and hyperuricemia (3/14, 21.4%) gnteuznuaw (txdwcrzarv )	Positive	16 Sep 2021
NCT04103905 (ESMO2020)	Phase 1	CD20 Positive B-Cell Non-Hodgkin Lymphoma	27	MIL62	(kvfxncbibv) = grade 1 infusion-related reaction was observed and experienced with 4 patients slprdrvdxo (ydipcvjwyz ) View more	Positive	17 Sep 2020

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Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

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