Delving into the Latest Updates on Silevimig with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

Target

RABV-G

Mechanism

RABV-G inhibitors(RABV-G inhibitors)

Therapeutic Areas

Infectious DiseasesOther Diseases

Active Indication

Rabies

Inactive Indication-

Originator Organization

Chongqing Genrix Biopharmaceutical Co., Ltd.

Active Organization

Chongqing Genrix Biopharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 708764380

Source: *****

Sequence Code 523912507

Source: *****

Sequence Code 523912505

Source: *****

The goal of this clinical trial is to compare the efficacy and safety of GR1801 injection with Human Rabies Immunoglobulin(HRIG) in patients with WHO Category 3 rabies exposure.
Patients will receive GR1801 injection or HRIG. Each group will receive rabies vaccine as the WHO Essen regime after Study Drug.

Start Date21 Oct 2022

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

CTR20222502 / Active, not recruitingPhase 3

GR1801注射液联合人用狂犬病疫苗在疑似狂犬病病毒III级暴露者中的有效性和安全性的III期临床试验

[Translation] Phase III clinical trial of the efficacy and safety of GR1801 injection combined with human rabies vaccine in subjects with suspected level III exposure to rabies virus

评价GR1801注射液联合人用狂犬病疫苗在疑似狂犬病病毒III级暴露者中的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of GR1801 injection combined with human rabies vaccine in subjects suspected of level III exposure to rabies virus.

Start Date21 Oct 2022

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

CTR20212115 / CompletedPhase 2

GR1801注射液与人用狂犬病疫苗联用在健康志愿者中的有效性和安全性剂量探索，以及药物相互作用研究

[Translation] Efficacy and safety dose exploration of GR1801 injection combined with human rabies vaccine in healthy volunteers, as well as drug interaction study

评价GR1801注射液与人用狂犬病疫苗在中国健康成年志愿者中联用的安全性、有效性及探索相互作用

[Translation]

To evaluate the safety and efficacy of GR1801 injection combined with human rabies vaccine in healthy adult volunteers in China and explore their interactions

Start Date13 Oct 2021

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Silevimig

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100 Translational Medicine associated with Silevimig

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100 Patents (Medical) associated with Silevimig

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1

Literatures (Medical) associated with Silevimig

01 Aug 2023·Journal of Medical Virology

Development of a novel bispecific antibody GR1801 for rabies

Article

Author: Wang, Lan ; Hao, Xiaobo ; Sun, Sheng ; Liu, Zhigang ; Long, Caifeng ; Bian, Lin ; Yu, Chuanfei ; Feng, Ye ; Wang, Wenbo ; Tu, Changchun

AbstractRabies is a zoonotic viral disease characterized by an almost 100% fatality rate once symptoms appear. However, it can be prevented through timely postexposure prophylaxis (PEP). Currently, there is a growing trend to replace polyclonal rabies immune globulin (RIG) with monoclonal antibodies (mAbs) in rabies PEP. In this study, we developed a human bispecific antibody, GR1801, by combining two mAbs, A2 and B353, which target distinct epitopes. GR1801 is an asymmetric immunoglobulin G1 molecule, with one arm (A2 targeting epitope III) in fragment antigen‐binding (Fab) form and the other arm (B353 targeting epitope I) in single‐chain variable fragment (scFv) form, constructed using Knobs‐into‐Holes technology. GR1801 demonstrated the ability to neutralize 90 naturally occurring rabies virus (RABV) glycoprotein antigenic variants, 21 pseudotyped, and 18 live street RABVs, exhibiting broad‐spectrum neutralizing activity. In vivo, GR1801 provided protection equivalent to that of human RIG in golden hamsters challenged with lethal RABV. In conclusion, these findings demonstrate the neutralization potency and breadth of GR1801, which can be a promising candidate drug for rabies PEP, and a comprehensive testing against a broad spectrum of Chinese prevalent RABVs will be investigated in great detail in the future for the in vitro and in vivo studies.

100 Deals associated with Silevimig

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