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

The goal of this clinical trial is to learn the efficaty and safety of BC001 in combination with Sintilimab and XELOX in treating patients with advanced or metastatic GC/GEJ.
Participants will:
Be administered with BC001, Sintilimab and Oxaliplatin once every three weeks for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.
Take Capecitabine once daily in the first two weeks of each three-week treatment cycle for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.

Start Date28 Feb 2025

Sponsor / Collaborator

Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.

CTR20231207

/ RecruitingPhase 3

BC001 联合紫杉醇对比安慰剂联合紫杉醇治疗经一线标准治疗失败的晚期胃或胃食管结合部腺癌的随机、双盲、平行对照Ⅲ期研究

[Translation] A randomized, double-blind, parallel-controlled phase III study of BC001 combined with paclitaxel versus placebo combined with paclitaxel in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma that has failed first-line standard treatment

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.

ChiCTR2300071906

/ Not yet recruitingPhase 3IIT

BC001 combined with paclitaxel versus placebo combined with paclitaxel in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma that has failed first-line standard therapy: a randomized, double-blind, parallel-controlled Phase III study

Start Date01 Mar 2023

Sponsor / Collaborator

Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.

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

01 Nov 2024·Cancer Medicine

Phase I study of BC001, a novel fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor‐2, in advanced solid tumors

Article

Author: Cha Wang ; Dan Liu ; Muling Liu ; Huan Zhou ; Chenwei Shang ; Jifang Gong ; Yanqiao Zhang ; Jian Yang ; Lin Shen ; Xinlei Guo ; Shumei Wang

Abstract:

Background:

BC001 is a novel fully human immunoglobulin G1 monoclonal antibody blocking VEGFR2. This phase I study aimed to assess BC001 alone and plus chemotherapy in solid tumors.

Methods:

In dose escalation part, BC001 was assessed at dose levels of 2, 4, 8, 12, 16 mg/kg on day 1,15, every 28 days, followed an accelerated titration and “3 + 3” design. BC001 plus paclitaxel was assessed at dose level of 8, 10 mg/kg. The primary endpoints included the DLT, MTD and RDE of BC001. In dose expansion part, it aimed to assess the anti‐tumor activity of BC001 alone and plus chemotherapy in gastric cancer as 2nd line treatment.

Results:

Overall, 53 patients were finally enrolled in this study (phase Ia, n = 28; phase Ib, n = 25). In phase Ia part, 1 DLT (grade 4 neutropenia lasting 4 days) was observed in BC001(8 mg/kg) plus paclitaxel cohort. MTD was not reached. All patients experienced TEAEs of any grade. Twenty‐four of them suffered ≥ grade 3 TEAEs. leukopenia (n = 33, 62.3%), hemoglobin decreased (n = 32, 60.4%), neutropenia (n = 29, 54.7%) were commonly observed hematological toxicities. The half‐life of 140‐240 h. And the PK parameters were not largely influenced by combination with paclitaxel. The serum sVEGFR‐1, VEGF‐A, sVEGFR‐2 could not predict the efficacy. Based on the safety, PK and efficacy data, BC001 of 8 mg/kg was determined as RED. Among the GC patients(n = 21) who receiving BC001 plus paclitaxel as 2nd‐line treatment in phase 1b part, 6 patients achieved PR and 10 patients experienced SD. The ORR was 28.6% (95% CI 11.3%, 52.2%) and the DCR was 76.2% (95% CI 52.8%, 91.8%), with the median PFS of 5.4 months (95% CI 1.9, 7.0) and OS of 9.4 months (95% CI 5.4, NA). The median DoR was 5.1 months (95% CI 2.6, NA).

Conclusions:

BC001 showed acceptable safety profile and preliminary response in both single‐agent and combination with chemotherapy cohorts, especially in GC.

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 ; Li, Xiao-Wen ; Yuan, Ye

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 Dec 2015·Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and TherapeuticsQ4 · MEDICINE

Vascular Endothelial Growth Factor Receptor 2 Antibody, BC001, Attenuates Laser-Induced Choroidal Neovascularization in Rhesus Monkeys ( Macaca mulatta )

Q4 · MEDICINE

Article

Author: Li, Hongxia ; Zhang, Jie ; Huang, Jingjing ; Wang, Xin ; Zhang, Yanyan ; Xiao, Kai ; Zhao, Tao ; Zhong, Zhihui ; Yuan, Ye ; Zhang, Ming ; Zhang, Yingqian

PURPOSE:

A study was conducted to evaluate the inhibitory effects of vascular endothelial growth factor receptor 2 (VEGFR2) monoclonal antibody, BC001, against laser-induced choroidal neovascularization (CNV).

METHODS:

We induced the experimental CNV in rhesus monkey eyes using laser photocoagulation. Monkeys were randomly assigned to 4 groups that received a single intravitreal administration of BC001 at 0 (vehicle-treated group), 0.05, 0.2, and 0.5 mg/eye. Fundus fluorescein angiography, optical coherence tomography, and histological studies were used for evaluations. The ocular recovery was determined by comparing changes of fluorescein leaking area and thickness of disrupted retina around the laser burn spot before and after drug administration. Choroidal blood vessels were stained and quantified by lectin staining. Hematoxylin and eosin staining was performed to determine the general histological complications.

RESULTS:

An intravitreal injection of BC001 at 0.05, 0.2, and 0.5 mg per eye at 20 days after laser burn significantly reduced the CNV-induced fluorescein leakage, retina pathology, and aberrant choroidal vessel growth and did not change intraocular pressure or induce any immune response.

CONCLUSION:

BC001 confers significant inhibitory effects against laser-induced CNV in rhesus monkeys, thereby suggesting that prevention of VEGFR2 activation may be promising as an alternative therapeutic target for exudative age-related macular degeneration.

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

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	Phase 3	China	Shandong Shenzhou Pharmaceutical Co. Ltd.	24 Aug 2023
HER2 positive Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Shandong Shenzhou Pharmaceutical Co. Ltd.	24 Aug 2023
Metastatic Gastric Carcinoma	Phase 1	China	Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.	28 Feb 2025
HER2 negative Gastroesophageal Junction Adenocarcinoma	Phase 1	China	Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.	25 Feb 2025
stomach adenocarcinoma	Phase 1	China	Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.	25 Feb 2025
Advanced Malignant Solid Neoplasm	Phase 1	China	Shandong Shenzhou Pharmaceutical Co. Ltd.	18 Mar 2019
Melanoma	Phase 1	China	Shandong Shenzhou Pharmaceutical Co. Ltd.	18 Mar 2019
Metastatic Colorectal Carcinoma	Phase 1	China	Shandong Shenzhou Pharmaceutical Co. Ltd.	18 Mar 2019
Non-Small Cell Lung Cancer	Phase 1	China	Shandong Shenzhou Pharmaceutical Co. Ltd.	18 Mar 2019
Renal Cell Carcinoma	Phase 1	China	Shandong Shenzhou Pharmaceutical Co. Ltd.	18 Mar 2019

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