Bispecific antibodies: formats, applications and products

Table of Contents

Products Introduction

Bispecific antibodies (BsAbs) are antibodies with two binding sites directed at two different antigens or two different epitopes on the same antigen. A bispecific antibody (bsAb) is designed and manufactured—through genetic recombination, chemical conjugation, or quadromas—to contain two target‐binding units in one antibody‐based molecule, whereby each unit independently recognizes its unique epitope. The clinical therapeutic effects of BsAbs are superior to those of monoclonal antibodies, with broad applications for tumor immunotherapy as well as for the treatment of other diseases. To meet the needs of BsAbs development, GeneMedi provides more than 500+ BsAbs products.

Case Study -- GeneMedi's GMP-Bios-ab-528 (Pre-Made Solitomab biosimilar) is validated to bind the Jurkat cells by Flow Cytometry (FACS Analysis)

GM R&D department tested the binding ability of GeneMedi’s GMP-Bios-ab-528 (Pre-Made Solitomab biosimilar) to the Jurkat cells by Flow Cytometry. Below is the conclusion:
1.Good binding of GM-528 to Jurkat cells.
2.High concentration (10ug/ml) of GM-528 should be used for CD3 detection.
3.The CD3 antibody is derived from L2K. The affinity of L2K is about 35 times lower than OKT3. (Therapeutic Window of MuS110, a Single-Chain Antibody Construct Bispecific for Murine EpCAM and Murine CD3. Cancer Res. 2008)

Figure 1. GeneMedi's GMP-Bios-ab-528 (Pre-Made Solitomab biosimilar) is validated to bind the Jurkat cells by Flow Cytometry (FACS Analysis).

Pipeline and MOA (mechanism of action) of bispecific antibodies (BsAbs)

Bridge of 2 cells (engagers)

By binding with 2 antigens from 2 different cells, the BsAbs can physically link them together, thus these kinds of BsAbs are named “engagers”. The redirecting of immune cells to tumor cells by the engagers makes the immune cell activated and then eliminate the target cells. The T cell engagers are the most popular BsAbs which account for nearly half of the clinical trials aimed evaluating the BsAbs. NK cell engagers are recently developed BsAbs for NK cell-dependent tumor cell elimination.

The engagers in research, clinical trials and market are listed below. Genemedi offers the high quality, premade benchmark BsAbs for researchers.

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Pre-Made Acapatamab biosimilar, Bispecific scFv, Anti-FOLH1/GCPII;CD3E Antibody: Anti-FGCP/GCP2/NAALAD1/PSM/PSMA/mGCP;T3E/TCRE/IMD18 therapeutic antibody
Acapatamab
FOLH1/GCPII,CD3E
Pre-Made Alnuctamab biosimilar, Bispecific mAb with Domain Crossover, Anti-TNFRSF17;CD3E Antibody: Anti-BCM/BCMA/CD269/TNFRSF13A;T3E/TCRE/IMD18 therapeutic antibody
Alnuctamab
TNFRSF17,CD3E
Pre-Made Blinatumomab biosimilar, Bispecific T-Cell Engager, Anti-CD19;CD3E Antibody: Anti-B4/CVID3;T3E/TCRE/IMD18 therapeutic antibody
Blinatumomab
CD19,CD3E
Pre-Made Cevostamab biosimilar, Bispecific mAb: Anti-FCRL5;CD3 therapeutic antibody
Cevostamab
FCRL5,CD3
Pre-Made Cibisatamab biosimilar, Bispecific mAb with Domain Crossover: Anti-CEACAM5;CD3E therapeutic antibody
Cibisatamab
CEACAM5,CD3E
Pre-Made Duvortuxizumab biosimilar, Bispecific scFv with Crossover, Anti-CD19;CD3E antibody: Anti-B4/CVID3;T3E/TCRE/IMD18 therapeutic antibody
Duvortuxizumab
CD19,CD3E
Pre-Made Eluvixtamab biosimilar, Bispecific scFv, Anti-CD33;CD3E Antibody: Anti-p67/SIGLEC3/SIGLEC-3;T3E/TCRE/IMD18 therapeutic antibody
Eluvixtamab
CD33,CD3E
Pre-Made Emerfetamab biosimilar, Bispecific scFv, Anti-CD33;CD3E Antibody: Anti-p67/SIGLEC3/SIGLEC-3;T3E/TCRE/IMD18 therapeutic antibody
Emerfetamab
CD33,CD3E
Pre-Made Envafolimab biosimilar, Single Domain Variable Fragment;H, Anti-CD274/PD-L1 Antibody: Anti-B7-H, B7H1, PD-L1, PDCD1L1, PDCD1LG1, PDL1, hPD-L1 therapeutic antibody
Epcoritamab
CD3E,MS4A1
Pre-Made Etevritamab biosimilar, Bispecific scFv, Anti-EGFR;CD3E Antibody: Anti-ERBB/ERRP/HER1/mENA/ERBB1/PIG61/NISBD2;T3E/TCRE/IMD18 therapeutic antibody
Etevritamab
EGFR,CD3E
Pre-Made Flotetuzumab biosimilar, Bispecific scFv with Crossover, Anti-IL3RA;CD3E Antibody: Anti-CD123/IL3RX/IL3RY/IL3RAY/hIL-3Ra;T3E/TCRE/IMD18 therapeutic antibody
Flotetuzumab
IL3RA,CD3E
Pre-Made Glofitamab biosimilar, Bispecific mAb with Domain Crossover, Anti-CD3E;MS4A1/CD20 antibody: Anti-T3E/TCRE/IMD18/CD3epsilon;B1/Bp35/CVID5/FMC7/LEU-16/S7therapeutic antibody
Glofitamab
CD3E,MS4A1
Pre-Made Mosunetuzumab biosimilar, Bispecific mAb, Anti-CD3E;MS4A1/CD20 Antibody: Anti-T3E/TCRE/IMD18/CD3epsilon;B1/Bp35/CVID5/FMC7/LEU-16/S7 therapeutic antibody
Mosunetuzumab
CD3E,MS4A1
Pre-Made Nivatrotamab biosimilar, Bispecific Mixed mAb and scFv, Anti-GD2;CD3E Antibody: Anti-T3E/TCRE/IMD18/CD3epsilon therapeutic antibody
Nivatrotamab
GD2,CD3E
Pre-Made Obrindatamab biosimilar, Bispecific scFv with Domain Crossover, Anti-CD276;CD3E Antibody: Anti-4Ig-B7-H3/B7-H3/B7H3/B7RP-2;T3E/TCRE/IMD18 therapeutic antibody
Obrindatamab
CD276,CD3E
Pre-Made Odronextamab biosimilar, Bispecific mAb, Anti-MS4A1/CD20;CD3E Antibody: Anti-B1/Bp35/CVID5/FMC7/LEU-16/S7;T3E/TCRE/IMD18 therapeutic antibody
Odronextamab
MS4A1,CD3E
Pre-Made Pacanalotamab biosimilar, Bispecific scFv, Anti-TNFRSF17;CD3E Antibody: Anti-BCM/BCMA/CD269/TNFRSF13A;T3E/TCRE/IMD18 therapeutic antibody
Pacanalotamab
TNFRSF17,CD3E
Pre-Made Pasotuxizumab biosimilar, Bispecific scFv, Anti-FOLH1/GCPII;CD3E Antibody: Anti-FGCP/GCP2/NAALAD1/PSM/PSMA/mGCP;T3E/TCRE/IMD18 therapeutic antibody
Pasotuxizumab
FOLH1,CD3E
Pre-Made Pavurutamab biosimilar, Bispecific scFv, Anti-TNFRSF17;CD3E Antibody: Anti-BCM/BCMA/CD269/TNFRSF13A;T3E/TCRE/IMD18 therapeutic antibody
Pavurutamab
TNFRSF17,CD3E
Pre-Made Plamotamab biosimilar, Bispecific Mixed mAb and scFv, Anti-MS4A1/CD20;CD3E Antibody: Anti-B1/Bp35/CVID5/FMC7/LEU-16/S7;T3E/TCRE/IMD18 therapeutic antibody
Plamotamab
MS4A1,CD3E
Pre-Made Runimotamab biosimilar, Bispecific mAb, Anti-ERBB2/HER2;CD3E Antibody: Anti-CD340/MLN 19/NEU/NGL/TKR1/VSCN2;T3E/TCRE/IMD18 therapeutic antibody
Runimotamab
ERBB2,CD3E
Pre-Made Solitomab biosimilar, Bispecific scFv, Anti-EPCAM;CD3E Antibody: Anti-Ber-Ep4/BerEp4/DIAR5/EGP-2/EGP314/EGP40/ESA/HNPCC8/KS1/4/KSA/M4S1/MIC18/MK-1/MOC-31/TACSTD1/TROP1;T3E/TCRE/IMD18 therape
Solitomab
EPCAM,CD3E
Pre-Made Talquetamab biosimilar, Bispecific mAb, Anti-GPRC5D;CD3E Antibody: Anti-T3E/TCRE/IMD18/CD3epsilon therapeutic antibody
Talquetamab
GPRC5D,CD3E
Pre-Made Tarlatamab biosimilar, Bispecific scFv, Anti-DLL3;CD3E Antibody: Anti-SCDO1;T3E/TCRE/IMD18 therapeutic antibody
Tarlatamab
DLL3,CD3E
Pre-Made Teclistamab biosimilar, Bispecific mAb, Anti-TNFRSF17;CD3E Antibody: Anti-BCM/BCMA/CD269/TNFRSF13A;T3E/TCRE/IMD18 therapeutic antibody
Teclistamab
TNFRSF17,CD3E
Pre-Made Tepoditamab biosimilar, Bispecific mAb, Anti-CLEC12A/CD371;CD3E Antibody: Anti-CLL-1/CLL1/DCAL-2/MICL;T3E/TCRE/IMD18 therapeutic antibody
Tepoditamab
CLEC12A,CD3E
Pre-Made Tidutamab biosimilar, Bispecific Mixed mAb and scFv, Anti-SSTR2;CD3E Antibody: Anti-T3E/TCRE/IMD18/CD3epsilon therapeutic antibody
Tidutamab
SSTR2,CD3E
Pre-Made Vibecotamab biosimilar, Bispecific Mixed mAb and scFv, Anti-IL3RA;CD3E Antibody: Anti-CD123/IL3RX/IL3RY/IL3RAY/hIL-3Ra;T3E/TCRE/IMD18 therapeutic antibody
Vibecotamab
IL3RA,CD3E
Pre-Made Vixtimotamab biosimilar, Bispecific Homodimer (VK-VH-VL'-VH', Tandem diabody)), Anti-CD3E;CD33 Antibody: Anti-T3E/TCRE/IMD18;p67/SIGLEC3/SIGLEC-3 therapeutic antibody
Vixtimotamab
CD3E,CD33
Pre-Made Elranatamab biosimilar, Whole mAb, Anti-TNFRSF17;CD3E Antibody: Anti-BCM/BCMA/CD269/TNFRSF13A;T3E/TCRE/IMD18 therapeutic antibody
Elranatamab
TNFRSF17,CD3E
Pre-Made Gresonitamab biosimilar, Whole mAb, Anti-CLDN18;CD3E Antibody: Anti-SFTA5/SFTPJ;T3E/TCRE/IMD18 therapeutic antibody
Gresonitamab
CLDN18,CD3E
Pre-Made Ivicentamab biosimilar, Whole mAb, Anti-CD37;CD37 Antibody: Anti-GP52-40/TSPAN26;GP52-40/TSPAN26 therapeutic antibody
Ivicentamab
CD37,CD37
Pre-Made Ubamatamab biosimilar, Whole mAb, Anti-MUC16;CD3E Antibody: Anti-CA125;T3E/TCRE/IMD18 therapeutic antibody
Ubamatamab
MUC16,CD3E
Pre-Made Vepsitamab biosimilar, Whole mAb, Anti-MUC17;CD3E Antibody: Anti-MUC-17/MUC-3/MUC3;T3E/TCRE/IMD18 therapeutic antibody
Vepsitamab
MUC17,CD3E
Pre-Made Voxalatamab biosimilar, Whole mAb, Anti-FOLH1/GCPII;CD3E Antibody: Anti-FGCP/GCP2/NAALAD1/PSM/PSMA/mGCP;T3E/TCRE/IMD18 therapeutic antibody
Voxalatamab
FOLH1,CD3E
Pre-Made Catumaxomab Biosimilar, Bispecific, Anti-Cd3E; Epcam Antibody: Anti-T3E/TCRE/IMD18/CD3epsilon;Ber-Ep4/BerEp4/DIAR5/EGP-2/EGP314/EGP40/ESA/HNPCC8/KS1/4/KSA/M4S1/MIC18/MK-1/MOC-31/TACSTD1/TROP
catumaxomab
CD3E,EPCAM
Pre-Made Cinrebafusp Alfa P Alfaiosimilar, Bispecific, Anti-ERBB2/HER2;TNFRSF9 Antibody: Anti-CD340/MLN 19/NEU/NGL/TKR1/VSCN2;ILA/4-1BB/CDw137 therapeutic antibody
cinrebafusp alfa
ERBB2,TNFRSF9
Pre-Made Ertumaxomab Biosimilar, Bispecific, Anti-Cd3E;Erbb2 Antibody: Anti-T3E/TCRE/IMD18/CD3epsilon;CD340/neu/MLN 19/NEU/NGL/TKR1/VSCN2 therapeutic antibody
ertumaxomab
CD3E,ERBB2

Targeting multiple receptors

Bridging receptors is an obligate mechanism in which the binding of BsAbs to 2 receptors causes the activation or inhibition of each receptor. The co-activation or inhibition synergistically enhanced the biological effect of single antibody.

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Pre-Made Acasunlimab biosimilar, Bispecific mAb, Anti-B7-H/B7H1/PDCD1L1/PDCD1LG1/PDL1/hPD-L1;ILA/4-1BB/CDw137 Antibod: Anti-CD274/PD-L1;TNFRSF9/CD137 therapeutic antibody
Acasunlimab
CD274/PD-L1,TNFRSF9/CD137
Pre-Made Amivantamab biosimilar, Bispecific mAb, Anti-EGFR;MET Antibody: Anti-ERBB/ERRP/HER1/mENA/ERBB1/PIG61/NISBD2;AUTS9/DFNB97/HGFR/RCCP2/c-Met therapeutic antibody
Amivantamab
EGFR,MET
Pre-Made Cadonilimab biosimilar, Bispecific Mixed mAb and scFv, Anti-PDCD1/PD-1;CTLA4/CTLA-4 antibody: Anti-CD279/PD1/SLEB2/hPD-1/hPD-l/hSLE1;CD/GSE/GRD4/ALPS5/CD152/IDDM12/CELIAC3 therapeutic antibo
Cadonilimab
PDCD1/PD-1,CTLA4/CTLA-4
Pre-Made Erfonrilimab biosimilar, Bispecific Single Domains (VH-VH'-CH), Anti-CD274/PD-L1;CTLA4/CTLA-4 Antibody: Anti-B7-H/B7H1/PDCD1L1/PDCD1LG1;CD/GSE/GRD4/ALPS5/CD152/IDDM12/CELIAC3 therapeutic ant
Erfonrilimab
CD274,CTLA4
Pre-Made Izuralimab biosimilar, Bispecific Mixed mAb and scFv, Anti-ICOS;PDCD1/PD-1 antibody: Anti-AILIM/CD278/CVID1;CD279/SLEB2/hPD-1/hPD-l/hSLE1 therapeutic antibody
Izuralimab
ICOS,PDCD1
Pre-Made Pavunalimab biosimilar, Bispecific Mixed mAb and scFv, Anti-LAG3;CTLA4/CTLA-4 Antibody: Anti-CD223;CD/GSE/GRD4/ALPS5/CD152/IDDM12/CELIAC3 therapeutic antibody
Pavunalimab
LAG3,CTLA4
Pre-Made Petosemtamab biosimilar, Bispecific mAb, Anti-EGFR;LGR5 Antibody: Anti-ERBB/ERRP/HER1/mENA/ERBB1/PIG61/NISBD2;FEX/GPR49/GPR67/GRP49/HG38 therapeutic antibody
Petosemtamab
EGFR,LGR5
Pre-Made Tebotelimab biosimilar, Bispecific scFv with Crossover, Anti-PDCD1/PD-1;LAG3 Antibody: Anti-CD279/PD1/SLEB2/hPD-1/hPD-l/hSLE1;CD223 therapeutic antibody
Tebotelimab
PDCD1,LAG3
Pre-Made Vudalimab biosimilar, Bispecific Mixed mAb and scFv, Anti-CTLA4/CTLA-4;PDCD1/PD-1 Antibody: Anti-CD/GSE/GRD4/ALPS5/CD152/IDDM12/CELIAC3;CD279/SLEB2/hPD-1/hPD-l/hSLE1 therapeutic antibody
Vudalimab
CTLA4,PDCD1
Pre-Made Zenocutuzumab biosimilar, Bispecific mAb, Anti-ERBB3/Erbb-3;ERBB2/HER2 Antibody: Anti-FERLK/HER3/LCCS2/MDA-BF-1/VSCN1/c-erbB3/erbB3-S/p180-ErbB3/p45-sErbB3/p85-sErbB3;CD340/neu/MLN 19/NEU/NG
Zenocutuzumab
ERBB3,ERBB2
Pre-Made Bafisontamab biosimilar, Whole mAb, Anti-EGFR;MET Antibody: Anti-ERBB/ERRP/HER1/mENA/ERBB1/PIG61/NISBD2;AUTS9/DFNB97/HGFR/RCCP2/c-Met therapeutic antibody
Bafisontamab
EGFR,MET
Pre-Made Fidasimtamab biosimilar, Whole mAb, Anti-PDCD1/PD-1;ERBB2/HER2 Antibody: Anti-CD279/PD1/SLEB2/hSLE1;CD340/neu/MLN 19/NEU/NGL/TKR1/VSCN2 therapeutic antibody
Fidasimtamab
PDCD1,ERBB2
Pre-Made Lorigerlimab biosimilar, Whole mAb, Anti-PDCD1/PD-1;CTLA4/CTLA-4 Antibody: Anti-CD279/PD1/SLEB2/hPD-1/hPD-l/hSLE1;CD/GSE/GRD4/ALPS5/CD152/IDDM12/CELIAC3 therapeutic antibody
Lorigerlimab
PDCD1,CTLA4
Pre-Made Simridarlimab biosimilar, Whole mAb, Anti-CD47;CD274/PD-L1 Antibody: Anti-IAP/OA3/MER6;B7-H/B7H1/PD-L1/PDCD1L1/PDCD1LG1/PDL1/hPD-L1 therapeutic antibody
Simridarlimab
CD47,CD274
Pre-Made Tecaginlimab biosimilar, Whole mAb, Anti-CD40;TNFRSF9/CD137 Antibody: Anti-p50/Bp50/CDW40/TNFRSF5;ILA/4-1BB/CDw137 therapeutic antibody
Tecaginlimab
CD40,TNFRSF9
Pre-Made Ensomafusp Alfa Alfaiosimilar, Bispecific, Anti-Cd19; Tnfrsf9 Antibody: Anti-B4/CVID3;ILA/4-1BB/CDw137 therapeutic antibody
ensomafusp alfa
CD19,TNFRSF9
Pre-Made Rovelizumab Biosimilar, Bispecific, Anti-Itgal;Itgb2 Antibody: Anti-CD11A/LFA-1/LFA1A;CD18/LAD/LCAMB/LFA-1/MAC-1/MF17/MFI7 therapeutic antibody
rovelizumab
ITGAL,ITGB2

ligand redundancy

In addition to bind to the receptors, targeting redundancy for cytokines or angiogenesis factors represents an area of interest for BsAbs.

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Pre-Made Dilpacimab biosimilar, Bispecific mAb, Anti-DLL4;VEGFA Antibody: Anti-AOS6/delta4/hdelta2;VPF/VEGF/MVCD1 therapeutic antibody
Dilpacimab
DLL4,VEGFA
Pre-Made Faricimab biosimilar, Bispecific mAb, Anti-VEGFA;ANGPT2 Antibody: Anti-VPF/VEGF/MVCD1;AGPT2/ANG2/LMPHM10 therapeutic antibody
Faricimab
VEGFA,ANGPT2
Pre-Made Istiratumab biosimilar, Bispecific Mixed mAb and scFv, Anti-IGF1R;ERBB3/Erbb-3 Antibody: Anti-IGFR/CD221/IGFIR/JTK13;FERLK/HER3/LCCS2/MDA-BF-1/VSCN1/c-c-erbB3/p180-ErbB3/p45-sErbB3/p85-sErbB
Istiratumab
IGF1R,ERBB3
Pre-Made Lutikizumab biosimilar, Bispecific Dual Variable Domain IG, Anti-IL1A;IL1B Antibody: Anti-IL1/IL-1A/IL1F1/IL1-ALPHA/IL-1 alpha;IL-1/IL1-BETA/IL1F2/IL1beta therapeutic antibody
Lutikizumab
IL1A,IL1B
Pre-Made Navicixizumab biosimilar, Bispecific mAb, Anti-DLL4;VEGFA Antibody: Anti-AOS6/delta4/hdelta2;VPF/VEGF/MVCD1 therapeutic antibody
Navicixizumab
DLL4,VEGFA
Pre-Made Remtolumab biosimilar, Bispecific Dual Variable Domain IG: Anti-IL17A/IL17;TNFA/TNF therapeutic antibody
Remtolumab
IL17A,TNFA
Pre-Made Romilkimab biosimilar, Bispecific Dual Variable Domain IG, Anti-IL13;IL4 Antibody: Anti-IL-13/P600;BCGF-1/BCGF1/BSF-1/BSF1/IL-4 therapeutic antibody
Romilkimab
IL13,IL4
Pre-Made Vanucizumab biosimilar, Bispecific mAb, Anti-ANGPT2;VEGFA Antibody: Anti-AGPT2/ANG2/LMPHM10;VPF/VEGF/MVCD1 therapeutic antibody
Vanucizumab
ANGPT2,VEGFA
Pre-Made Dalutrafusp Alfa P Alfaiosimilar, Bispecific, Anti-NT5E/CD73;TGFB1;TGFB3 Antibody: Anti-eN/NTE/eNT/CALJA;CED/DPD1/IBDIMDE/LAP/TGF-beta1/TGFbeta;ARVD/ARVD1/LDS5/RNHF therapeutic antibody
dalutrafusp alfa
NT5E,TGFB1,TGFB3

Biparatopic bsAbs

Instead of targeting two different proteins, bsAbs may be designed to simultaneously bind to two non-overlapping epitopes on the same target. Biparatopic targeting builds on increasing binding strength through antigen crosslinking and aggregation, thereby mimicking effects observed for antibody mixtures and polyclonal antibodies. Biparatopic bsAbs are therefore essentially a combinatorial concept

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Pre-Made Anbenitamab biosimilar, Bispecific mAb: Anti-ERBB2 (Domain II);ERBB2 (Domain IV) therapeutic antibody
Anbenitamab
ERBB2 (Domain II),ERBB2 (Domain IV)
Pre-Made Zanidatamab biosimilar, Bispecific mAb, Anti-ERBB2/HER2;ERBB2/HER2 Antibody: Anti-CD340/HER-2/MLN 19/NEU/NGL/TKR1/VSCN2;CD340/neu/MLN 19/NEU/NGL/TKR1/VSCN2 therapeutic antibody
Zanidatamab
ERBB2,ERBB2
Pre-Made Zanidatamab Zovodotin B Zovodotiniosimilar, Bispecific/Biparatopic, Anti-ERBB2/HER2;ERBB2/HER2 Therapeutic/Biparatopic Antibody Antibody: Anti-CD340/MLN 19/NEU/NGL/TKR1/VSCN2;CD340/neu/MLN 1
zanidatamab zovodotin
ERBB2,ERBB2
Pre-Made Efdamrofusp Alfa P Alfaiosimilar, Bispecific, Anti-C3/CO3;C4B;VEGFA Antibody: Anti-AHUS5/ARMD9/ASP/CPAMD1/HEL-S-62p;CH/C4F/CO4/C4BD/C4B12/CPAMD3;VPF/MVCD1 therapeutic antibody
efdamrofusp alfa
C3,C4B,VEGFA

Cofactor mimetics

BsAbs can also be designed as a scaffold or cofactor linking enzyme and substrate together. One of the applications is the BsAbs used as a substitution of a critical clotting factor in the treatment of hemophilia.

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Pre-Made Emicizumab biosimilar, Bispecific mAb, Anti-F9;F10 Antibody: Anti-FIX/HEMB/P19/PTC/THPH8;FX/FXA therapeutic antibody
Emicizumab
F9,F10

Piggyback approaches

Exploit the first binding specificity of a BsAb as a transport modality for the second specificity are named the “piggyback” approaches. To cross the blood-brain barrier, one binding arm of the BsAbs are designed to target the transferrin receptor (TfR). The human serum albumin (HSA) targeting domain are used to extent the half-life of BsAbs, especially to BsAbs without Fc, for example the tandem ScFvs or VHHs. In addition, the piggyback approaches are also been used in promoting the degradation of pathogens.

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Pre-Made Gontivimab biosimilar, Bispecific Single Domains (VH-VH'-VH¡¯): Anti-RSV gpF therapeutic antibody
Gontivimab
RSV gpF
Pre-Made Gremubamab biosimilar, Bispecific mAb: Anti-PcrV type III secretion system; Polysaccharide synthesis locus (Pseudomonas) therapeutic antibody
Gremubamab
PcrV type III secretion system,Polysaccharide synthesis locus (Pseudomonas)
Pre-Made Isecarosmab biosimilar, Bispecific Single Domains (VH-VH'), Anti-ADAMTSL5;ALB Antibody: Anti-THSD6;FDAHT/HSA/PRO0883/PRO0903/PRO1341 therapeutic antibody
Isecarosmab
ADAMTSL5,ALB
Pre-Made Ozoralizumab biosimilar, Bispecific Single Domains (VH-VH'-VH), Anti-TNFA/TNF;ALB Antibody: Anti-DIF/TNF-alpha/TNFSF2/TNLG1F;FDAHT/HSA/PRO0883/PRO0903/PRO1341 therapeutic antibody
Ozoralizumab
TNFA,ALB
Pre-Made Vobarilizumab biosimilar, Bispecific Single Domains (VH-VH'), Anti-IL6R;ALB Antibody: Anti-CD126/HIES5/IL-1Ra/IL-6R/IL-6R-1/IL-6RA/IL6Q/IL6QTL/IL6RA/IL6RQ/gp80;FDAHT/HSA/PRO0883/PRO0903/PRO1
Vobarilizumab
IL6R,ALB
Pre-Made Tifalibep Biosimilar, Bispecific, Anti-Alb;Fcgrt Antibody: Anti-FDAHT/HSA/PRO0883/PRO0903/PRO1341;FCRN/FcgammaRn/alpha-chain therapeutic antibody
tifalibep
ALB,FCGRT
Pre-Made Izokibep Biosimilar, Bispecific, Anti-ALB;IL17A/IL17 Antibody: Anti-FDAHT/HSA/PRO0883/PRO0903/PRO1341;CTLA-8/CTLA8A therapeutic antibody
izokibep
ALB,IL17A
Pre-Made Sonelokimab Biosimilar, Bispecific, Anti-ALB;IL17A/IL17;IL17F Antibody: Anti-FDAHT/HSA/PRO0883/PRO0903/PRO1341;CTLA-8/CTLA8/IL-17A/ILA17;CANDF6/ML-1/ML1 therapeutic antibody
sonelokimab
ALB,IL17A,IL17F

Introduction about bispecific antibodies (BsAbs)

Bispecific antibodies (BsAbs) are designed to bind two different epitopes or antigens, which leads to multiple mechanistic functions with synergistic effects. The attractive feature is their potential for novel functionalities, which do not exist in mixtures of the parental or reference antibodies. Till now, more than 200 BsAb-based clinical trails have been registered on clinicaltrails.org and 4 BsAbs (with one withdraw) have been granted FDA approval. The promising future makes BsAbs attracting more attentions.

The connecting of two specificities within one BsAb can be exploited for novel therapeutic concepts. The mostly applications of BsAbs are recruiting effector cells to the target cells, which are regarded as the immune cell engagers. The redirection of the cytotoxic effector cells (T and NK cells) to the targeting cancer cells by BsAbs physically link them together and activate the effector cells to eliminate the target ones. In addition, the BsAbs can also be used to link two molecules together to make the therapeutic effects such as the dual inhibition of immune checkpoints, the conditionally activate a growth factor receptor for diabetes treatment and the replacement of natural bridge molecules such as the coagulation factor VIII. More innovative designs of BsAbs can be achieved in the future.

To accelerate the development of BsAbs, Genemedi offers the high quality, premade benchmark BsAbs for researchers. The biosimilars are expressed by mammalian cell line and used for biological drug discovery items including cell culture, assay development, animal model development, PK/PD model development (Pharmacokinetics & Pharmacodynamic) and mechanism of action (MOA) research.

Formats of bispecific antibodies (BsAbs)

Many formats have been developed for BsAb generation as listed in the following table.

FormatSchematic structureDescriptionExample BsAbTrademark Company
tandem VHHTandem VHH fragment-based BsAbN/A
tandem scFvPicture loading failed.Tandem ScFv fragment-based BsAbAMG330BiTETMAmgen
Dual-affinity re-targeting antibodyPicture loading failed.Tandem domain-exchanged Fv (can also be used to fuse with Fc domain to create whole Abs)FlotetuzumabDARTTMMacrogenics
DiabodyPicture loading failed.dimer of single-chain Fv (scFv) fragmentvixtimotamabReSTORETMAmphivena Therapeutics
(scFv)2-FabPicture loading failed.a Fab domain and two scFv domains bindA-337ITabTMGeneron/EVIVE Biotech
Rat–mouse hybrid IgGPicture loading failed.Full-size IgG-like half antibodies from two different speciesCatumaxomabTriomabTMTrion Pharma
Hetero heavy chain, Common light chainPicture loading failed.Hetero heavy chain, Common light chainEmicizumabART-IgTMGenentech/ Chugai/Roche
Controlled Fab arm exchangePicture loading failed.Recombin the parental half antibodies JNJ-64007957DuobodyTMGenmab/ Janssen
Hetero H, forced HL IgG1Picture loading failed.KIH technology for heterodimerization of 2 distinct H chains, replacing the native disulfide bond in one of the CH1-CL interfaces with an engineered disulfide bond to enhance the cognate of H and L paringMEDI5752DuetMabTMMedImmune/ AstraZeneca
cH IgG1Picture loading failed.Identical heavy chains; 2 different light chains: one kappa (κ) and one lambda (λ)NI-1701κλ bodyTMNovimmune SA
Hetero H, CrossMabPicture loading failed.KIH technology; domain crossover of immunoglobulin domains in the Fab regionVanucizumabCrossMabTMRoche
scFv-Fab IgGPicture loading failed.Fab-Fc; ScFv-FcVibecotamab;
M802
XmabTM (the engineered Fc to enhance the generation of heterodimeric Fc);
YBODYTM
Xencor/Amgen; YZYBio
VH1-VH2-CH1-Fc1(G1) x VL2-VL1-CL-Fc2(G1)Picture loading failed.2 binding motif in one half antibodySAR440234CODV-IgTMSanofi
VL1-CL1-VH2-CH2-Fc x VH1-CH1 x VL2-CL2Picture loading failed.2 binding motif in one half antibodyEMB-01FIT-IgTMEPIMAB BIOTHERAPEUTICS
VH-1-TCR Cα x VL-1-TCR Cβ; VH-2-CH-2-Fc x VL-2-CL-2Picture loading failed.KIH technology; TCR Cα/Cβ is used to substitute the CH1 and CL domain in one armWuXibodyTMWuXi Biologics
C-terminal linker of FcPicture loading failed.Link the other molecules at the C-terminal of FcAPVO442ADAPTIR-FLEXTMAptevo Therapeutics
Fc antigen binding sitePicture loading failed.2 natural binding sites; 2 additional binding sites in the Fc loopFS118mAb2F-star Therapeutics

Bispecific Antibody Development Programs Guidance for Industry by FDA

FDA set up the guidance for the development of BsAbs. The link and PDF files are listed below.

Bispecific Antibody Development Programs Guidance for Industry
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