Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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) |
| Target(s) | BCMA, CD3 |
| Indications of clinical studies | Multiple myeloma |
| Primary therapeutic area | Cancer |
| 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 | 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/ |
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;
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |