Delving into the Latest Updates on Recombinant human anti-VEGFR2 monoclonal antibody(Shandong Buchang) with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

BC 001, BC-001, BC001

Target

VEGFR2

Mechanism

VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Gastroesophageal junction adenocarcinomaAdvanced Malignant Solid NeoplasmHER2 negative Gastroesophageal Junction Adenocarcinoma+ [2]

Inactive Indication-

Originator Organization

Shandong Buchang Pharmaceuticals Co., Ltd.

Active Organization

Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.Shandong Shenzhou Pharmaceutical Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationSpecial Review Project (CN)

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1、主要目的：评价BC001联合紫杉醇对比安慰剂联合紫杉醇在一线标准治疗失败的胃或胃食管结合部腺癌患者的总生存期（OS）。 2、次要目的（1）评价 BC001 联合紫杉醇对比安慰剂联合紫杉醇在一线标准治疗失败的胃或胃食管结合部腺癌患者的无进展生存期（PFS）、客观缓解率（ORR）、缓解持续时间（DOR）、疾病控制率（DCR）、至治疗失败时间（TTF）、患者自我报告结局（PRO）；（2）评价 BC001 联合紫杉醇对比安慰剂联合紫杉醇在一线标准治疗失败的胃或胃食管结合部腺癌患者的安全性特征；（3）评价 BC001 联合紫杉醇对比安慰剂联合紫杉醇在一线标准治疗失败的胃或胃食管结合部腺癌患者的免疫原性特征。（4）基于群体药代动力学（PopPK）分析方法，评价 BC001 的 PK特征。（5）探索 BC001 的暴露与效应之间的关系。

[Translation]

1. Primary objective: To evaluate the overall survival (OS) of BC001 combined with paclitaxel versus placebo combined with paclitaxel in patients with gastric or GEJ adenocarcinoma who have failed first-line standard treatment. 2. Secondary objectives (1) To evaluate the progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to treatment failure (TTF), and patient-reported outcomes (PRO) of BC001 combined with paclitaxel versus placebo combined with paclitaxel in patients with gastric or GEJ adenocarcinoma who have failed first-line standard treatment; (2) To evaluate the safety characteristics of BC001 combined with paclitaxel versus placebo combined with paclitaxel in patients with gastric or GEJ adenocarcinoma who have failed first-line standard treatment; (3) To evaluate the immunogenicity characteristics of BC001 combined with paclitaxel versus placebo combined with paclitaxel in patients with gastric or GEJ adenocarcinoma who have failed first-line standard treatment. (4) To evaluate the PK characteristics of BC001 based on the population pharmacokinetic (PopPK) analysis method. (5) Explore the relationship between exposure and effect of BC001.

Start Date24 Aug 2023

Sponsor / Collaborator

Shandong Shenzhou Pharmaceutical Co. Ltd.

CTR20181073 / CompletedPhase 1

在中国晚期实体瘤受试者中展开的BC001 I期临床研究

[Translation] Phase I clinical study of BC001 in Chinese subjects with advanced solid tumors

在晚期实体瘤受试者中，评估BC001单独和联合紫杉醇静脉输注给药的安全性和耐受性，确定最大耐受剂量（MTD）和/或扩展阶段推荐剂量（RDE），为后续临床试验给药方案和剂量提供依据。

[Translation]

In subjects with advanced solid tumors, the safety and tolerability of BC001 administered by intravenous infusion alone or in combination with paclitaxel will be evaluated to determine the maximum tolerated dose (MTD) and/or recommended dose (RDE) for the expansion phase, providing a basis for the dosing regimen and dose of subsequent clinical trials.

Start Date18 Mar 2019

Sponsor / Collaborator

Shandong Shenzhou Pharmaceutical Co. Ltd.

100 Clinical Results associated with Recombinant human anti-VEGFR2 monoclonal antibody(Shandong Buchang)

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100 Translational Medicine associated with Recombinant human anti-VEGFR2 monoclonal antibody(Shandong Buchang)

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100 Patents (Medical) associated with Recombinant human anti-VEGFR2 monoclonal antibody(Shandong Buchang)

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26

Literatures (Medical) associated with Recombinant human anti-VEGFR2 monoclonal antibody(Shandong Buchang)

01 Dec 2023·International journal of oncology

[Corrigendum] Fully human VEGFR2 monoclonal antibody BC001 attenuates tumor angiogenesis and inhibits tumor growth.

Author: Yang, De-Xuan ; Xuan, Zi-Xue ; Yuan, Shou-Jun ; Wang, Shan-Shan ; Xu, Cheng-Wang ; Li, Lin-Na ; Zhang, Qi ; An, Ying-Hong ; Yuan, Ye ; Li, Xiao-Wen

Subsequently to the publication of the above paper, an interested reader drew to the authors' attention that, for the scratch wound assay experiments shown in Fig. 1 on p. 2413, the panels showing the '0 h' experiments for the respective incubations with VEGF or BC001 were apparently identical. The authors were able to re‑examine their original data files, and realized that this figure had been inadverently assembled incorrectly. The revised version of Fig. 1, containing the correct data for the '0 h / BC001' panel, is shown below. Note that the revisions made to this figure do not affect the overall conclusions reported in the paper. The authors are grateful to the Editor of International Journal of Oncology for allowing them the opportunity to publish this Corrigendum, and apologize to the readership for any inconvenience caused. [International Journal of Oncology 45: 2411‑2420, 2014; DOI: 10.3892/ijo.2014.2690].

01 Feb 2023·Cardiovascular engineering and technology

Spiral Laminar Flow is Associated with a Reduction in Disturbed Shear in Patient-Specific Models of an Arteriovenous Fistula

Article

Author: Houston, J Graeme ; Walsh, Michael T ; Moran, Daniel T ; Ross, Rose A ; Broderick, Stephen P ; Cunnane, Connor V

PURPOSE:

Areas of disturbed shear that arise following arteriovenous fistula (AVF) creation are believed to contribute to the development of intimal hyperplasia (IH). The presence of helical flow can suppress areas of disturbed shear, which may protect the vasculature from IH. Therefore, the aim of this study is to determine if helical flow, specifically spiral laminar flow (SLF), is present in patient-specific AVF models and is associated with a reduction in exposure to disturbed shear.

METHODS:

Four AVF were imaged using MRI within the first two weeks following fistula creation. Patient-specific boundary conditions were obtained using phase-contrast MRI and applied at the inlet and outlets of each model. Computational fluid dynamics was used to analyse the hemodynamics in each model and compare the helical content of the flow to the distribution of disturbed shear.

RESULTS:

BC-1 and RC-2 are characterised by the presence of SLF, which coincides with the lowest distribution of disturbed shear. Contrastingly, SLF is absent from BC-2 and RC-1 and experience the largest amount of disturbed shear. Interestingly, BC-2 and RC-1 developed an anastomosis stenosis, while BC-1 and RC-2 remained stenosis free.

CONCLUSION:

These findings are in agreement with previous clinical studies and further highlight the clinical potential of SLF as a prognostic marker for a healthy AVF, as its presence correlates with an overall reduction in exposure to disturbed shear and a decrease in the incidence of AVF dysfunction, albeit in a small sample size.

01 May 2022·BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONSQ3 · BIOLOGY

Anti-VEGFR2 monoclonal antibody(MSB0254) inhibits angiogenesis and tumor growth by blocking the signaling pathway mediated by VEGFR2 in glioblastoma

Q3 · BIOLOGY

Article

Author: Chen, Sansong ; Zhou, Youxin ; Wang, Hao ; Li, Xuetao ; Chen, Guangliang

Angiogenesis is a key physiological process that plays a key role in glioblastoma (GBM) progression and displays therapeutic resistance to antiangiogenic therapies. In this study, we aimed to identify whether vascular endothelial growth factor receptor 2(VEGFR2)monoclonal antibodies(mab)could inhibit tumorigenicity and the formation of vascular mimicry (VM) in GBM. The bioinformatic analysis from TCGA, CGGA, and TCPA databases and Immunohistochemistry (IHC) revealed that VEGFR2 is highly expressed in glioma tissues and results in a poor prognosis and is positively associated with VM markers (CD34 and PAS). The anti-VEGFR2 monoclonal antibodies(MSB0254)could inhibit the invasion, migration, and VM formation of U251 and primary glioma cells in vitro. In vivo, MSB0254 (m) could not only inhibit the growth of transplanted tumors of U251 and GL261 cells, but also significantly inhibit the expression of CD34, VEGFR2, Ki67, MMP2, MMP9 and reduce the expression of CD34/PAS and inhibit VM formation. The VEGFR2 monoclonal antibody could inhibit the angiogenesis and tumor growth of GBM by blocking the signaling pathway mediated by VEGFR2. It may become a new supplementary treatment for GBM.

100 Deals associated with Recombinant human anti-VEGFR2 monoclonal antibody(Shandong Buchang)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	Phase 3	CN	Shandong Shenzhou Pharmaceutical Co. Ltd.	24 Aug 2023
Advanced Malignant Solid Neoplasm	Phase 1	CN	Shandong Shenzhou Pharmaceutical Co. Ltd.	18 Mar 2019
HER2 negative Gastroesophageal Junction Adenocarcinoma	IND Approval	CN	Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.	26 Feb 2024
Metastatic gastric adenocarcinoma	IND Approval	CN	Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.	26 Feb 2024
Metastatic Colorectal Carcinoma	IND Approval	CN	Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.	06 Nov 2023