Structure of a BiTE. VH:
Heavy chain variable regions. VL:
Light chain variable regions. Different specificity is marked with different colours and shapes. The arrows point from
N- to
C-terminus.
Bi-specific T-cell engagers (BiTEs) are 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. BiTE is a registered
trademark of
Micromet AG (fully owned subsidiary of Amgen Inc).[1]
Like other bispecific antibodies, and unlike ordinary monoclonal antibodies, BiTEs form a link between T cells and tumor cells. This causes T cells to exert
cytotoxic activity on tumor cells by producing proteins like
perforin and
granzymes, independently of the presence of
MHC I or
co-stimulatory molecules. These proteins enter tumor cells and initiate the cell's
apoptosis.[2][4]
This action mimics physiological processes observed during T cell attacks against tumor cells.[4]
BiTEs in clinical assessment or with clinical approvals
Several BiTEs are currently in preclinical and clinical trials to assess their therapeutic efficacy and safety. [5]
Blinatumomab links T cells with CD19 receptors found on the surface of B cells. The Food and Drug Administration (US) and the European Medicines Agency approved this therapy for adults with Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia.[6]
It is a bispecific CD20-directed CD3 T-cell engager. It was approved for medical use in Canada in March 2023, in the United States in June 2023, and in the European Union in July 2023.
The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea.[18]
It was approved for medical use in the United States in May 2024.[18][19]
After clinical trials, in January 2022, the
US FDA approved tebentafusp (a BiTE targeting the
gp100 peptide) for HLA-A*02:01-positive adult patients with unresectable or metastatic
uveal melanoma.[20]
Another avenue for novel anti-cancer therapies is re-engineering some of the currently used conventional antibodies like
trastuzumab (targeting
HER2/neu),
cetuximab and
panitumumab (both targeting the
EGF receptor), using the BiTE approach.[22]
^
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^"Talvey EPAR". European Medicines Agency. 21 September 2023. Retrieved 6 October 2023.
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ab"Talquetamab". NCI Drug Dictionary. National Cancer Institute.
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^"Talvey Product information". Union Register of medicinal products. 22 August 2023.
Archived from the original on 25 August 2023. Retrieved 25 August 2023.