YAbS







Silevimig Clinical Bispecific

Antibody Information

Entry ID 674
INN Silevimig
Status Clinical
Drug code(s) GR1801
Brand name None
mAb sequence source mAb human
General Molecular Category Bispecific
Format, general category Fragment-Fc
Format details scFv-Fc-Fab
Isotype (Fc) IgG1
Light chain isotype TBD
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology Phage library

Therapeutic information

Target(s) Rabies virus (glycoprotein)
Indications of clinical studies Post exposure prophylaxis
Primary therapeutic area Infectious diseases

Development stage information

Phase lengths*
*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).
Most advanced stage of development (global) Phase 3
Status Active
Start of clinical phase (IND filing or first Phase 1) November 01, 2020
Start of Phase 2 October 17, 2021
Start of Phase 3 October 24, 2022
Date BLA/NDA submitted to FDA
Year of first approval (global) None
Date of first US approval
INN, US product name None
US or EU approved indications None

Company information

Company Genrix (Shanghai) Biopharmaceutical Co. Ltd.
Licensee/Partner None
Comments about company or candidate Listed as Phase 3 in company pipeline dated Aug 2024 (http://www.genrixbio.com/#/science?classId=class3)
NCT05846568 / CTR20222502 Phase 3 started in Oct 2022.
CTR20212115 Phase 2 started in Oct 2021.
CTR20202023 Phase 1 started in Nov 2020.
Full address of company Shanghai, China
Asia
China
https://synapse.patsnap.com/organization/575cf201cc223eac2f65ac65cddb2931

Description/comment

GR1801 is a human bispecific antibody, which simultaneously recognizes antigenic sites I and III of the RABV G protein. Antigen-binding fragments targeting epitope I and III of the RABV G protein were designed as a scFv and a Fab form, respectively, to construct human IgG1 heterodimers based on the Knob-Into-Hole (KIH) technology. Specifically, the A2 antigen-binding fragment in Fab form was fused to the N-terminus of an Fc segment containing the Knob mutation, while the B353 antigen-binding fragment in scFv form was fused to the N-terminus of an Fc segment containing the Hole mutation. This process resulted in the construction of the bispecific antibody GR1801, targeting the RABV G protein. Three constructed vectors expressing B353-scFv-FcH, A2VH-IgG1K, and A2VK-VK were cotransfected into HEK293F cells using liposomes. The bispecific antibodies GR1801 present in the culture supernatant were purified using a Protein A/G affinity chromatography. https://doi.org/10.1002/jmv.29016

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None