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NI-1501 is a bispecific T-cell engager (BiTE) antibody candidate developed by Light Chain Bioscience (formerly NovImmune) using their proprietary κλ-body platform. This platform generates fully human IgG-like bispecific antibodies with a common light chain, which facilitates standard manufacturing processes while enabling dual targeting. NI-1501 is designed to treat Carcinoembryonic Antigen-Related Cell Adhesion Molecule 5 (CEACAM5)-expressing solid tumors, with a primary focus on colorectal cancer. The molecule simultaneously binds to CEACAM5 on the surface of tumor cells and the CD3 epsilon subunit of the T-cell receptor complex on T-lymphocytes. This dual binding recruits and activates cytotoxic T-cells in close proximity to the tumor, leading to the formation of an immunological synapse and subsequent tumor cell lysis. By redirecting the patient's own immune system to specifically attack CEACAM5-positive malignant cells, NI-1501 aims to provide a potent and targeted therapeutic option for patients with advanced solid tumors.
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