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Several bsAb drugs have been approved by the US FDA / EMA and over 180 are currently in clinical trials. The first bispecific antibody to gain regulatory approval, blinatumomab, targets CD19 on B cells and CD3 on T cells, leading to the activation of T cells and the destruction of B cells. [31]
Bi-specific T-cell engager (BiTE) is a class of artificial bispecific monoclonal antibodies that are investigated for use as anti-cancer drugs. They direct a host's immune system, more specifically the T cells ' cytotoxic activity, against cancer cells.
Epcoritamab, sold under the brand name Epkinly, is a monoclonal antibody anticancer medication used for the treatment of diffuse large B-cell lymphoma. [4] [7] Epcoritamab is a bispecific CD20-directed CD3 T-cell engager. [4] [7] Epcoritamab was co-developed by AbbVie and Genmab. [8]
The bispecific antibodies have arrived in the clinic. In 2009, the bispecific antibody catumaxomab was approved in the European Union [40] [41] and was later withdrawn for commercial reasons. [42] Others include amivantamab, blinatumomab, teclistamab, and emicizumab. [43]
Emicizumab, sold under the brand name Hemlibra, is a humanized bispecific monoclonal antibody for the treatment of haemophilia A, developed by Genentech and Chugai (both organizations are subsidiaries of Hoffmann-La Roche). [4] A Phase I clinical trial found that it was well tolerated by healthy subjects. [5]
Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of large B-cell lymphoma. [10] It is a bispecific CD20-directed CD3 T-cell engager developed by Roche. [7] The most common side effects include cytokine release syndrome, muscle and bone pain, rash, and tiredness. [11]
Blinatumomab linking a T cell to a malignant B cell.. Blinatumomab is a bispecific T-cell engager (BiTE). [7] It enables a patient's T cells to recognize malignant B cells. A molecule of blinatumomab combines two binding sites: a CD3 site for T cells and a CD19 site for the target B cells.
Solitomab (INN; development code MT110) is an artificial bispecific monoclonal antibody that is being investigated as an anti-cancer drug.It is a fusion protein consisting of two single-chain variable fragments (scFvs) of different antibodies on a single peptide chain of about 55 kilodaltons.
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