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 |
Target(s) | Rabies virus (glycoprotein) |
Indications of clinical studies | Post exposure prophylaxis |
Primary therapeutic area | Infectious diseases |
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 | 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 |
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
Anticipated events | None |
Factor(s) contributing to discontinuation | None |