YAbS







Verenafusp alfa Clinical Immunoconjugate

Antibody Information

Entry ID 2854
INN Verenafusp alfa
Status Clinical
Drug code(s) GNR-055
Brand name None
mAb sequence source mAb chimeric
General Molecular Category Immunoconjugate
Format, general category Fragment fusion
Format details None
Isotype (Fc) None
Light chain isotype kappa
Linker None
Ave. DAR None
Conjugated/fused moiety IDS
Discovery method/technology None

Therapeutic information

Target(s) Insulin receptor
Indications of clinical studies Mucopolysaccharidosis Type II
Primary therapeutic area Metabolic disorders

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 2/3
Status Active
Start of clinical phase (IND filing or first Phase 1) January 15, 2020
Start of Phase 2
Start of Phase 3 November 30, 2021
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 AO GENERIUM
Licensee/Partner None
Comments about company or candidate NCT05208281 Phase 2/3 started in Nov 2021
NCT04539340 Phase 1 started in Feb 2020
Full address of company 123112 Moscow, Testovskaya str., 10, entrance 2
Europe
Russia
https://www.generium.ru/en/contacts/

Description/comment

chimeric immunoglobulin G1-kappa antigen-binding fragment (Fab) anti-[human insulin receptor (INSR)] fused at the C-terminus of the heavy chain via peptide linker 221LSS223 to human iduronate-2- sulfatase fragment, glycoform alfa;

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None