主要目的：评估注射用BG136在健康受试者中单次和多次静脉滴注给药的安全性和耐受性。次要目的：评估健康受试者单次和多次静脉滴注注射用BG136的药代动力学（PK）和药效动力学（PD）特征；评估注射用BG136在健康受试者体内安全有效的剂量范围，为Ⅱ期临床研究的给药方案提供依据；评估注射用BG136在健康受试者体内免疫原性。

开始日期2023-08-19

申办/合作机构

中国海洋大学

[+2]

NCT05984368 / Recruiting临床1期IIT

First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation and Multiple Dose Escalation Phase I Clinical Trial of BG136 for Injection in Healthy Subjects

This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion administration dose groups. Prior to the formal initiation of the dose-escalation trial, the safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)

开始日期2023-08-18

申办/合作机构

青岛大学附属医院

100 项与 BG-136 相关的临床结果

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100 项与 BG-136 相关的转化医学

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100 项与 BG-136 相关的专利（医药）

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项与 BG-136 相关的文献（医药）

2024-11-01·International Journal of Biological Macromolecules

A β-1,3/1,6-glucan enhances anti-tumor effects of PD1 antibody by reprogramming tumor microenvironment

Article

作者: Zhang, Minghui ; Lv, Youjing ; Zhao, Jun ; Liu, Shan ; Zhang, Xiaonan ; Zhou, Mingming ; Lu, Peizhe ; Song, Qiaoling ; Yu, Guangli ; Zhao, Chenyang ; Wu, Lijuan ; Xu, Xiaohan ; Yang, Jinbo ; Zhang, Xinxin ; Xu, Yuting ; Li, Quancai ; Hu, Ting

Checkpoint blockades have emerged as a frontline approach in cancer management, designed to enhance the adaptive immune response against tumors. However, its clinical efficacy is limited to a narrow range of tumor types, which necessitates the exploration of novel strategies that target another main branch of the immune system. One such potential strategy is the therapeutic modulation of pattern recognition receptors (PRRs) pathways in innate immune cells, which have shown promise in tumor eradication. Previously, a β-1,3/1,6-glucan with high purity from Durvillaea antarctica (BG136) was reported by our group to exhibit pan-antitumor effects. In the current study, we systemically studied the antitumor activity of BG136 in combination with anti-PD1 antibody in MC38 syngeneic tumor model in vivo. Integrated transcriptomic and metabolomic analyses suggested that BG136 enhanced the antitumor immunity of anti-PD1 antibody by reprogramming the tumor microenvironment to become more proinflammatory. In addition, an increase in innate and adaptive immune cell infiltration and activation, enhanced lipid metabolism, and a decrease in ascorbate and aldarate metabolism were also found. These findings provide mechanistic insights that support the potent antitumor efficacy of BG136 when combined with immune checkpoint inhibitor antibodies.

2019-10-01·Carbohydrate Polymers1区 · 化学

A β-1,3/1,6-glucan from Durvillaea Antarctica inhibits tumor progression in vivo as an immune stimulator

1区 · 化学

Article

作者: Guan, Huashi ; Zhao, Chenyang ; Song, Qiaoling ; Xu, Xiaohan ; Zhang, Chuanliang ; Li, Mengyuan ; Wu, Lijuan ; Yang, Jinbo ; Qu, Xianjun ; Yu, Guangli ; Yao, Dan ; Su, Fan

β-glucans trigger the proinflammatory responses of innate immune cells to enhance the host defense. A variety of β-glucans were identified as strong immune stimulator and exerted antitumor activities. Our previous work indicates that a β-1,3/1,6-glucan (BG136) derived from marina alga Durvillaea antarctica promotes the proinflammatory responses in macrophage cell line RAW264.7. In the present study, we further explored its antitumor effects in vivo as an immune stimulator. The data shows that BG136 alone decreases the tumor burdens in DLD1 xenograft and AOM-DSS induced tumor models. BG136 also augments the antitumor effects of PD-1 antibody in B16 syngeneic tumor model. BG136 increases macrophage phagocytosis, enhances cytokine/chemokine secretion and modulates the systemic and intratumoral immune cell composition. Collectively, these data suggest that BG136 might act as an immune stimulator to exert antitumor effects in vivo.

2018-07-01·Carbohydrate Polymers1区 · 化学

A β-glucan from Durvillaea Antarctica has immunomodulatory effects on RAW264.7 macrophages via toll-like receptor 4

1区 · 化学

Article

作者: Li, Jia ; Shan, Xindi ; Yang, Yi ; Wang, Ya ; Jiang, Hao ; Hao, Jiejie ; Yu, Guangli ; Ma, Wenbang ; Zhao, Xiaoliang

We studied the mechanisms underlying the immunostimulatory effects of aβ-1,3/1,6-glucan (BG136) from Durvillaea Antarctica. Our data showed that BG136 promoted the activation of MAPKs and NF-κB signaling pathways and cytokines production. BG136 did not increase MCP-1 or NO production or phosphorylation of NF-κB and MAPK in TLR4 siRNA knockdown cells, indicating that BG136 activates macrophages through TLR4. Flow cytometry analysis and confocal experiment showed that BG136 bound to TLR4 expressed on RAW264.7 macrophage cells surface. The affinity of BG136 for TLR4 was determined using Surface Plasmon Resonance (SPR) (KD: 4.51 × 10^-6M). Altogether, our results showed that BG136 activates RAW264.7 cells by binding to TLR4 and then triggering TLR4-mediated signaling pathways to promote cytokines secretion.

项与 BG-136 相关的新闻（医药）

2022-09-27

·医药笔记

4.6亿元：豪森药业引进骨关节炎药物，从金针菇纯化的壳聚糖

▎Armstrong2022年9月26日，翰森制药发布公告，从比利时生物技术公司KiOmed引进骨关节炎治疗药物KiOmedine one，翰森制药支付预付款、里程碑金额共计6600万欧元，约合4.6亿元人民币，以及一定比例的销售分成。KiOmedine one为一种来自金针菇的、高度纯化的多糖，用于治疗骨关节炎的单次注射剂。临床研究表明，单次注射KiOmedinevsOne后，2周内疼痛明显减轻，骨关节炎指数(WOMAC)疼痛评分降低了66%，响应率高达76%。骨关节炎症状的减轻至少可持续6个月。KiOmedinevsOne已获得CE认证，并于2021年在欧洲获批上市。总结KiOmed成立于2012年，是一家从事天然(非动物源)壳聚糖研发、生产和销售的公司企业。拥有超天然(非动物源)壳聚糖衍生物专利技术和创新技术平台，产品管道覆盖骨科、眼科、医美等领域。2022年8月，华东医药从KiOmed获得4项壳聚糖医疗美容产品的授权，支付400万欧元预付款，1000万欧元里程碑金额，以及一定比例的销售分成。国内方面，治疗阿尔茨海默症的971为来自褐藻的海洋多糖，971之后，，青岛海洋生物医药研究院在开发更多海洋寡糖药物。2020年12月16日，抗肿瘤药物BG136的临床试验申请获得NMPA受理。BG136为来自南极海茸（Durvillaea Antarctica）的β-1,3/1,6-葡聚糖。----------------------感兴趣的读者可以加入“医药笔记”知识星球。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

抗体抗体药物偶联物

100 项与 BG-136 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床1期	中国	青岛海洋生物医药研究院	2023-08-19
晚期恶性实体瘤	临床1期	中国	正大制药（青岛）有限公司	2023-08-19
晚期恶性实体瘤	临床1期	中国	中国海洋大学	2023-08-19
实体瘤	临床申请批准	中国	青岛利福特生物医学研究所	2022-09-19