YAbS







Etentamig Clinical Bispecific

Antibody Information

Entry ID 198
INN Etentamig
Status Clinical
Drug code(s) ABBV-383, TNB-383B
Brand name None
mAb sequence source mAb human
General Molecular Category Bispecific
Format, general category Fragment-Fc
Format details Fab-h-CH2-CH3 x VH-VH-h-CH2-CH3
Isotype (Fc) IgG4
Light chain isotype kappa
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology Transgenic rat (OmniFlic)

Therapeutic information

Target(s) BCMA, CD3
Indications of clinical studies Multiple myeloma
Primary therapeutic area Cancer

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) May 15, 2019
Start of Phase 2
Start of Phase 3 May 09, 2024
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 Amgen
Licensee/Partner AbbVie
Comments about company or candidate NCT06158841 Phase 3 in MM started in May 2024.
Dec 2022: Two Phase 1 studies started in 2022; NCT05650632 in MM started in March 2023
Amgen acquired Teneobio, Inc.
June 2021: Still listed in AbbVie pipeline.
Nov 2019: Teneobio announced that its bispecific antibody, TNB-383B, was granted orphan drug status as a potential therapy for multiple myeloma. NCT03933735 Phase 1 study started June 2019.
February 11, 2019 I AbbVie, Teneobio, Inc. and its affiliate TeneoOne, Inc. announced that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma. B-cell maturation antigen (BCMA) has emerged as an attractive target for multiple myeloma therapeutics. Teneobio is expected to begin the clinical program for TNB-383B in the first half of 2019. Combination of Teneobio’s anti-CD3 antibodies with other fixed light chain or heavy chain antibodies enables a “plug-and-play” approach to tailor the next generation of bi- and multi-specific antibodies for T-cell redirection on a target-specific basis, with reduced toxicity compared to conventional CD3 engaging bispecifics. http://drug-dev.com/Main/Back-Issues/ANTIBODY-THERAPEUTICS-Teneobios-Next-Generation-of-1421.aspx
Full address of company Thousand Oaks, California, United States
North America
United States of America
https://www.amgen.com/

Description/comment

TNB-383B is a bispecific antibody that simultaneously targets BCMA and CD3, utilizing Teneobio's unique anti-CD3 platform. Through this dual targeting mechanism, TNB-383B is designed to direct the body's own immune system to target and kill BCMA expressing tumor cells. TNB-383B is a next-generation fully human bispecific monoclonal IgG4 antibody. It consists of two heavy and one light chain(s) paired using knob-in-hole technology. Heavy chain 1 and the kappa light chain form the paratope that recognizes and binds with low affinity to human CD3, whereas heavy chain 2 is composed of two identical VH domains in sequence and targets BCMA with high affinity and avidity https://doi.org/10.1002/jha2.69
Immunoglobulin G4-kappa, anti-[Homo sapiens CD3E (CD3 epsilon)] and anti-[Homo sapiens TNFRSF17 (TNF receptor superfamily member 17, BCMA, TNFRSF13A, CD269)], Homo sapiens and humanized monoclonal antibody, bispecific, trivalent;

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None