预约演示
更新于：2026-10-28
Beijing Mabworks Biotech Co., Ltd.
更新于：2026-10-28
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肿瘤
免疫系统疾病
泌尿生殖系统疾病
单克隆抗体
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NCT07405970
A Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.
NCT07375758
A Phase I/II, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy
NCT06232096
A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed/Refractory Multiple Myeloma.
100 项与 北京天广实生物技术股份有限公司 相关的临床结果
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2026-10-01NATURE MEDICINE
Obinutuzumab β for aquaporin-4-positive neuromyelitis optica spectrum disorder: a phase 3 randomized controlled trial
Article
作者: Xiang, Feng ; Xu, Yuming ; Xiao, Lianchen ; Chen, Ting ; Wu, Lei ; Zhou, Hongyu ; Zhai, Feipeng ; Feng, Juan ; Deng, Bingmei ; Meng, Zhaoyou ; Wu, Zhe ; Li, Xiaofeng ; Fan, Weihao ; Meng, Qiang ; Zhu, Runxiu ; Meng, Li ; Li, Xiaoling ; Zhang, Qing ; Li, Feng ; Liu, Hong ; Chen, Junbin ; Wang, Zhe ; Liu, Sijun ; Zang, Weizhou ; Huang, Dehui ; Yang, Huan ; Li, Zunbo ; Qiu, Wei ; Liu, Xifang ; Wei, Min ; Meng, Huaxing ; Gu, Liangliang ; Qiu, Feng ; Zhang, Cun-Jin ; Gao, Feng ; Liang, Jinjin ; Dai, Tingjun ; Tian, Dai-Shi ; Li, Bin ; Duan, Ruisheng
Although CD20-directed B cell depletion has long been used in neuromyelitis optica spectrum disorder (NMOSD), high-quality, large-scale, randomized controlled trials remain limited. In this multicenter, randomized, double-blind phase 3 trial, we evaluated obinutuzumab β (MIL62), a novel glycoengineered type II anti-CD20 monoclonal antibody, in patients with NMOSD. Eligible participants aged 18-70 years with aquaporin-4-immunoglobulin G (AQP4-IgG)-seropositive NMOSD and an Expanded Disability Status Scale (EDSS) score of 7.0 or lower were randomly assigned (1:1) to receive intravenous obinutuzumab β 1,000 mg (n = 45) or placebo (n = 46). The primary outcome-time to first adjudicated relapse on or before week 52-was met: relapse occurred in two of 45 (4.4%) obinutuzumab β-treated participants and in 21 of 46 (45.7%) placebo-treated participants (hazard ratio = 0.069, 95% confidence interval: 0.016-0.296, P < 0.0001). The incidence of grade 3 or higher treatment-related adverse events was similar between the obinutuzumab β group (6.7%) and the placebo group (6.5%). These findings support obinutuzumab β as a glycoengineered type II anti-CD20 therapeutic option for patients with AQP4-IgG+ NMOSD. ClinicalTrials.gov identifier: NCT05314010 .
2025-11-01Journal for ImmunoTherapy of Cancer
Oncolytic virus-induced IL-1β
+
monocyte-IL-6
+
CAF axis suppresses dendritic cell-mediated antitumor immunity in pancreatic cancer
Article
作者: Wang, Jie ; Yu, Junfeng ; Liu, Shiyu ; Zhang, Hongkai ; Han, Minghui ; Li, Fan ; Zhao, Zhigang ; Deng, Li ; Wang, Yi ; Wan, Yajuan ; Chen, Jingru ; Li, Yuanke ; Wang, Wei ; Li, Jiangmei ; Yang, Yi ; Wang, Han ; Zhang, Zhaoyuan ; Cao, Youjia ; Xu, Song ; Zhou, Feilong ; Ma, Wenxuan ; Zhao, Zhen
Background:
Pancreatic ductal adenocarcinoma (PDAC) is characterized by a profoundly immunosuppressive tumor microenvironment, which features a dense desmoplastic stroma enriched with cancer-associated fibroblasts (CAFs) that collectively impede the efficacy of immunotherapies. Although oncolytic viruses (OVs) have demonstrated promising potential in eliciting antitumor immunity, the mechanisms by which stromal components modulate OV efficacy remain poorly understood.
Methods:
To investigate the interplay between immune and stromal components in PDAC following OV treatment, we employed murine and patient-derived tumor models. We characterized immune cell populations using single-cell RNA sequencing and flow cytometry. Functional studies included the engineering of a next-generation oncolytic herpes simplex virus expressing FLT3 ligand, OX40 ligand, and interleukin-12 (IL-12), combined with CD40 agonist antibodies to restore dendritic cell (DC) function and enhance T-cell responses.
Results:
We identified a novel immunosuppressive circuit wherein monocytes, sensing damage-associated molecular patterns and pathogen-associated molecular patterns from OV-infected tumor cells, secrete interleukin-1β. This, in turn, triggers IL-6 production by CAFs, creating an IL-6-rich milieu that impairs DC maturation and co-stimulatory signaling, thereby attenuating T cell-mediated antitumor immunity and restricting OV therapeutic efficacy. Importantly, combination therapy with the engineered OV and CD40 agonist antibodies restored DC functionality and elicited robust tumor-specific T-cell responses in both murine and patient-derived models.
Conclusion:
Our findings reveal a previously unrecognized monocyte-CAF-DC axis that mediates resistance to OV therapy through IL-1β and IL-6-driven suppression of DC function in PDAC. This study provides a mechanistically informed and translationally promising approach to overcome stromal immune suppression, restore effective antitumor immunity, and improve therapeutic outcomes for patients with PDAC.
2018-08-18mAbs2区 · 医学
Structural and functional characterization of MBS301, an afucosylated bispecific anti-HER2 antibody
2区 · 医学
Article
作者: Feng, Jiannan ; Shen, Beifen ; Zhang, Boyan ; Jin, Chunyang ; Fan, Xiaochuan ; Liu, Huifang ; Huang, Sijia ; Yuan, Xinqiu ; Li, Feng ; Ye, Pei ; Chen, Jin ; Wu, Zhidan
MBS301, a glyco-engineered bispecific anti-human epidermal growth factor receptor 2 (HER2) antibody with a typical IgG1 monoclonal antibody structure, was developed through dual-cell expression and in vitro assembling process. MBS301 consists of two half antibodies engineered from trastuzumab and pertuzumab, respectively. Integrity and purity profiles of MB301 indicated that the heterodimerization of the two half antibodies was successful. The high and similar melting temperatures (Tm1,72.0°C and Tm2, 84.8°C) of MBS301 compared with those of its parental monoclonal antibodies trastuzumab and pertuzumab (in-house made T-mab and P-mab, respectively) revealed its structural compactness. With computer-modeling experiments and Biacore binding and competition kinetics studies, the binding stoichiometry between MBS301 and HER2-ECD was determined to be 1:1 and the two arms of MBS301 were shown to bind to domains II and IV of HER2-ECD antigen simultaneously. MBS301 displayed synergistic bioactivities as the combination of T-mab and P-mab in vitro in multiple cancer cell lines and in vivo in xenograft mouse model studies, and showed more effective activity than T-mab or P-mab used individually. Moreover, fucose-knockout dramatically increased MBS301's binding affinity to low affinity FcγRIIIa allotype 158F (KD = 2.35 × 10-7M) to near the high affinity level of allotype V158 (KD = 1.17 × 10-7M). This resulted in far more effective ADCC activity of MBS301 than the combination of T-mab and P-mab in killing HER2-positive cancer cells. Hence, a novel fully afucosylated anti-HER2 bispecific antibody with improved antitumor activities was generated and shown to have the potential to be used for treating HER2-positive but trastuzumab-resistant solid tumors.
100 项与 北京天广实生物技术股份有限公司 相关的药物交易
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100 项与 北京天广实生物技术股份有限公司 相关的转化医学
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