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更新于：2026-04-25
Biosion, Inc.
更新于：2026-04-25
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NCT07086768
A Phase Ia/Ib, 2-Part, Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
NCT05932654
A Phase 2a, Multicenter, Proof-of-Concept Clinical Trial to Evaluate Efficacy and Safety of BSI-045B mAb Injection in Patients With Moderate to Severe Atopic Dermatitis
NCT05114889
A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate Safety and Tolerability of BSI-045B mAb Injection in Healthy Adult Subjects and Patients With Atopic Dermatitis
100 项与 博奥信生物技术（南京）有限公司 相关的临床结果
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2026-02-26JOURNAL OF MEDICINAL CHEMISTRY
Modulation of Tumor Microenvironment via Antibody Mediated Precision Delivery of CpG to Myeloid Cell
Article
作者: Ma, Zemeng ; Ji, Liezhou ; Yu, Xiang ; Yang, Zhen ; Chen, Mingjiu ; Hao, Xiaoyao ; Ma, Zhigang ; Li, Hongyan ; Baigude, Huricha ; Wang, Jialong
CpG oligodeoxynucleotides (CpG ODNs) are short, synthetically produced DNA molecules that serve as classic agonists of Toll-like receptor 9 (TLR9). They are known for their ability to combat infection, alleviate allergic responses, and inhibit tumor growth. However, free CpG is rapidly degraded by nucleases, distributes poorly, and accumulates minimally in tumors. To overcome these limitations, CpG was tethered to tumor-associated antigens or antibodies that engage Fcγ receptors on immune cells in previous studies. Here we redirected CpG toward myeloid cells via SIRPα, an innate immune checkpoint expressed in dendritic cells and macrophages that transmits "don't-eat-me" signals upon binding tumor-expressed CD47. The conjugate potently matured bone marrow-derived dendritic cells in vitro and, after simple intraperitoneal delivery, safely suppressed tumor growth in vivo. This myeloid-targeted CpG platform broadens the design space for TLR9 agonists and offers an off-the-shelf strategy for integrating innate and adaptive immunity against cancer.
2024-07-01Current Analytical Chemistry
A Novel Electrochemiluminescence (ECL) Immunoassay for the Quantitation
of Monoclonal Antibody (mAb) PYX-106 in Human Serum
作者: Wang, Jianxin ; Balogh, Gabriela A. ; Simon, Teri ; Squicciarini, Mariana ; Yin, Feng ; Pinkas, Jan ; Adhikari, Diana ; Harriman, Shawn ; Yang, Wensheng ; Liu, Xiaodong F. ; Dyszel, Mike ; Ke, Yan ; Bruce, Lisa ; Lei, Wenji
Background:::
PYX-106 is a novel monoclonal antibody (mAb), targeting the sialic acidbinding
immunoglobulin-like lectin 15 (Siglec-15) in the Tumor Microenvironment (TME). Precise
measurement of PYX-106 is essential for the thorough assessment of PYX-106 pharmacokinetics
in clinical investigations.
Methods:::
A novel Electrochemiluminescence (ECL) immunoassay for the quantitation of PYX-
106 in human serum was developed and validated. Biotinylated anti-PYX-106 antibody Bio-A1A1
was employed as the capture antibody, and ruthenylated anti-PYX-106 antibody Ru-A3G10 was
utilized as the detection antibody in the ECL immunoassay on Meso Scale Discovery (MSD) platform.
Results:::
This assay was fully validated in terms of selectivity, accuracy, precision, hook effect,
stability, etc., with a dynamic range from 50.0 to 2,500 ng/mL in human serum under the 2018
U.S. Food and Drug Administration (FDA) guidance and the 2022 U.S. FDA ICH M10 guidance.
Conclusion:::
PYX-106 bioanalytical assay validation was reported for the first time in a biological
matrix, and this assay has been successfully applied to support a clinical trial PYX-106-101.
2020-10-01EBioMedicine1区 · 医学
A novel HER2-targeting antibody 5G9 identified by large-scale trastuzumab-based screening exhibits potent synergistic antitumor activity
1区 · 医学
ArticleOA
作者: Chen, Mingjiu ; Gu, Wanjian ; Luo, Lan ; Ding, Xiaoyu ; Xia, Shukai ; Hao, Xiaoyao ; Zhang, Chunni ; Zhong, Yujie ; Liu, Jinyu
BACKGROUND:
Pertuzumab is currently used in combination with trastuzumab as the first-line treatment for HER2-positive metastatic breast cancer. However, pertuzumab was originally developed independently from trastuzumab and was later incidentally found to have synergistic efficacy when combined with trastuzumab, it remains to be seen whether a more potent synergistic efficacy partner exists for trastuzumab.
METHODS:
A trastuzumab-based functional assay was used to screen anti-HER2 antibodies harboring trastuzumab-synergistic antitumor activity. The lead candidate 5G9, in combination with trastuzumab, was further characterized for its bioactivities in cell proliferation, cell apoptosis, antigen-antibody endocytosis and HER2-mediated cell signaling pathway blocking. Finally, animal models were used to evaluate the in vivo synergistic antitumor efficacy of 5G9 in combination with trastuzumab.
FINDINGS:
Compared to pertuzumab, 5G9 demonstrated more potent synergistic cell growth inhibitory activity when combined with trastuzumab (85% vs. 55%, P<0.001). In addition, 5G9 exhibited a higher internalization rate than pertuzumab (20% vs. 9%, P<0.05), and was able to further synergize with trastuzumab to promote antigen-antibody endocytosis. The internalization rate of the combination of 5G9 and trastuzumab was higher than that of pertuzumab and trastuzumab (35% vs. 14%, P<0.001). In vivo animal studies demonstrated that 5G9 in combination with trastuzumab showed more potent synergistic antitumor efficacy than the combination of pertuzumab and trastuzumab.
INTERPRETATION:
5G9, together with trastuzumab, may provide a potential opportunity for more efficacious treatment of HER2-positive cancers.
FUNDING:
National Natural Science Foundation of China; State Key Laboratory of Analytical Chemistry for Life Science.
100 项与 博奥信生物技术（南京）有限公司 相关的药物交易
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100 项与 博奥信生物技术（南京）有限公司 相关的转化医学
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