Delving into the Latest Updates on Recombinant anti-EGFR chimeric monoclonal antibody(Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.) with Synapse

初步评价 CPGJ602 两种给药方案与爱必妥®分别联合 mFOLFOX6 治疗KRAS/NRAS/BRAF 野生型转移性结直肠癌患者的有效性，安全性和耐受性，包括免疫原性。并评价CPGJ602 两种给药方案的群体药代动力学特征及暴露效应关系分析及考察循环肿瘤 DNA动态变化对于CPGJ602 和爱必妥®的疗效是否存在影响。

[Translation]

The aim is to preliminarily evaluate the efficacy, safety and tolerability, including immunogenicity, of two dosing regimens of CPGJ602 and Erbitux® in combination with mFOLFOX6 in the treatment of patients with KRAS/NRAS/BRAF wild-type metastatic colorectal cancer. The aim is to evaluate the population pharmacokinetic characteristics and exposure-effect relationship analysis of the two dosing regimens of CPGJ602 and investigate whether the dynamic changes of circulating tumor DNA affect the efficacy of CPGJ602 and Erbitux®.

Start Date07 Dec 2020

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

CTR20190958 / CompletedPhase 1

重组抗EGFR人鼠嵌合单克隆抗体注射液与爱必妥？在健康男性志愿者中药代动力学特性、免疫原性和安全性比对研究

[Translation] Comparative study on the pharmacokinetic properties, immunogenicity and safety of recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection and Erbitux in healthy male volunteers

主要目的：比较重组抗EGFR人鼠嵌合单克隆抗体注射液（以下简称CPGJ602）与爱必妥®在健康男性志愿者中的PK特征次要目的：比较CPGJ602与爱必妥®在健康男性志愿者中的安全性和免疫原性

[Translation]

Primary objective: To compare the PK characteristics of recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection (hereinafter referred to as CPGJ602) and Erbitux® in healthy male volunteers Secondary objective: To compare the safety and immunogenicity of CPGJ602 and Erbitux® in healthy male volunteers

Start Date23 Jul 2019

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

100 Clinical Results associated with Recombinant anti-EGFR chimeric monoclonal antibody(Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.)

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100 Translational Medicine associated with Recombinant anti-EGFR chimeric monoclonal antibody(Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.)

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100 Patents (Medical) associated with Recombinant anti-EGFR chimeric monoclonal antibody(Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.)

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Literatures (Medical) associated with Recombinant anti-EGFR chimeric monoclonal antibody(Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.)

01 Jul 2024·Genes to Cells

DNMT1 can induce primary germ layer differentiation through de novo DNA methylation

Article

Author: Surani, M. Azim ; Kubiura‐Ichimaru, Musashi ; Ito, Takashi ; Ito, Takamasa ; Yamaguchi, Shinpei ; Tada, Masako ; Miura, Fumihito ; Tajima, Shoji

AbstractDNA methyltransferases and Ten‐Eleven Translocation (TET) proteins regulate the DNA methylation and demethylation cycles during mouse embryonic development. Although DNMT1 mainly plays a role in the maintenance of DNA methylation after DNA replication, it is also reported to possess de novo methyltransferase capacity. However, its physiological significance remains unclear. Here, we demonstrate that full‐length DNMT1 (FL) and a mutant lacking the N‐terminus necessary for its maintenance activity (602) confer the differentiation potential of mouse Dnmt1, Dnmt3a, and Dnmt3b (Dnmts‐TKO) embryonic stem cells (ESCs). Both FL and 602 inhibit the spontaneous differentiation of Dnmts‐TKO ESCs in the undifferentiated state. Dnmts‐TKO ESCs showed loss of DNA methylation and de‐repression of primitive endoderm‐related genes, but these defects were partially restored in Dnmts‐TKO + FL and Dnmts‐TKO + 602 ESCs. Upon differentiation, Dnmts‐TKO + FL ESCs show increased 5mC and 5hmC levels across chromosomes, including pericentromeric regions. In contrast, Dnmts‐TKO + 602 ESCs didn't accumulate 5mC, and sister chromatids showed 5hmC asynchronously. Furthermore, in comparison with DNMT1_602, DNMT1_FL effectively promoted commitment to the epiblast‐like cells and beyond, driving cell‐autonomous mesendodermal and germline differentiation through embryoid body‐based methods. With precise target selectivity achieved by its N‐terminal region, DNMT1 may play a role in gene regulation leading to germline development.

01 Feb 2024·Carbohydrate Research

Rhamnose modified antibodies show improved immune killing towards EGFR-positive solid tumor cells

Article

Author: Hong, Haofei ; Li, Yanchun ; Wu, Zhimeng ; Zhao, Jie ; Zhou, Kun ; Li, Dan

Therapeutic monoclonal antibodies (mAbs) against the epidermal growth factor receptor (EGFR) have shown clinical efficacy in colorectal cancer and other solid cancers. Enhancing the effector functions of these anti-EGFR mAbs is believed to be a valuable approach to achieve improved efficacy in clinical setting. Here, we report the development of an effector function-enhanced antibody by rhamnose (Rha) functionalization. Cetuximab, a human/mouse chimeric anti-EGFR mAb, was selected and site-specifically conjugated with Rha haptens. The obtained cetuximab-Rha conjugate was shown to be able to selectively redirect amounts of endogenous anti-Rha antibodies onto EGFR-positive solid tumor cells and thereby provide more Fc domains to achieve enhancement of effector functions including complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated phagocytosis (ADCP). Particularly, CDC, one powerful cell killing mechanism which is inactive in cetuximab, was dramatically improved. This study demonstrates the potential of rhamnose-modified antibody for EGFR-positive solid tumor immunotherapy.

02 Nov 2015·Molecular PharmaceuticsQ2 · MEDICINE

A Chimeric Cetuximab-Functionalized Corona as a Potent Delivery System for Microtubule-Destabilizing Nanocomplexes to Hepatocellular Carcinoma Cells: A Focus on EGFR and Tubulin Intracellular Dynamics

Q2 · MEDICINE

Article

Author: Panda, Dulal ; Kini, Sudarshan ; Srivastava, Rohit ; Poojari, Radhika

In this study, we have developed microtubule destabilizing agents combretastatin A4 (CA4) or 2-methoxyestradiol (2ME) encapsulated poly(d,l-lactide-co-glycolide)-b-poly(ethylene glycol) (PLGA-b-PEG) nanocomplexes for targeted delivery to human hepatocellular carcinoma (HCC) cells. An epidermal growth factor receptor (EGFR) is known to be overexpressed in HCC cells. Therefore, the targeting moiety cetuximab (Cet), an anti-EGFR chimeric monoclonal antibody, is functionalized on the surface of these diblock copolymeric coronas. Cetuximab is associated with the extracellular domain of the EGFR; therefore, the uptake of the cetuximab conjugated nanocomplexes occurred efficiently in EGFR overexpressing HCC cells indicating potent internalization of the complex. The cetuximab targeted-PLGA-b-PEG nanocomplexes encapsulating CA4 or 2ME strongly inhibited phospho-EGFR expression, depolymerized microtubules, produced spindle abnormalities, stalled mitosis, and induced apoptosis in Huh7 cells compared to the free drugs, CA4 or 2ME. Further, the combinatorial strategy of targeted nanocomplexes, Cet-PLGA-b-PEG-CA4 NP and Cet-PLGA-b-PEG-2ME NP, significantly reduced the migration of Huh7 cells, and markedly enhanced the anticancer effects of the microtubule-targeted drugs in Huh7 cells compared to the free drugs, CA4 or 2ME. The results indicated that EGFR receptor-mediated internalization via cetuximab facilitated enhanced uptake of the nanocomplexes leading to potent anticancer efficacy in Huh7 cells. Cetuximab-functionalized PLGA-b-PEG nanocomplexes possess a strong potential for the targeted delivery of CA4 or 2ME in EGFR overexpressed HCC cells, and the strategy may be useful for selectively targeting microtubules in these cells.

100 Deals associated with Recombinant anti-EGFR chimeric monoclonal antibody(Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 2	CN	3SBio, Inc.	30 Jan 2022
RAS/BRAF Wild Type HER2 Positive Colorectal Cancer	Phase 2	CN	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	29 Sep 2021
Metastatic Colorectal Carcinoma	Phase 2	CN	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	07 Dec 2020
RAS/BRAF Wild Type Colorectal Cancer	Phase 1	CN	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	07 Dec 2020
RAS Wild Type Colorectal Cancer	Phase 1	CN	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	06 Nov 2017

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04466254 (ASCO2022) Manual	Phase 2	RAS/BRAF Wild Type Colorectal Cancer First line KRAS Wild-type \| NRAS Wild-type \| BRAF Wild-type	76	mFOLFOX6+CPGJ602 (biweekly group)	(uooxnkbqto) = qzvnpddqlf txjvphozcb (vczinqpxox, 60.3 - 92.0) View more	Positive	02 Jun 2022
				mFOLFOX6+CPGJ602 (weekly group)	(uooxnkbqto) = fikczvtwiu txjvphozcb (vczinqpxox, 62.5 - 92.5) View more