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The EGFR-specific BiTE antibody is a bispecific T-cell engager designed to treat EGFR-expressing solid tumors, such as colorectal cancer. Developed by Micromet (now Amgen), this therapeutic candidate belongs to a next-generation BiTE platform featuring a human anti-CD3 single-chain antibody fragment that is cross-reactive with non-human primates, specifically Cynomolgus monkeys, facilitating comprehensive preclinical safety and toxicity assessments. The molecule functions by transiently connecting T cells to EGFR-positive tumor cells, inducing the formation of an immunological synapse and subsequent T-cell-mediated apoptosis of the target cell. Preclinical studies in monkeys established a maximum tolerated dose (MTD) of 150 µg/m²/kg, with toxicity primarily driven by target-dependent binding rather than non-specific T-cell activation.
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