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NI-3301 is a bispecific antibody (Kλ body) designed to provide a costimulatory signal to T cells by co-engaging carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5, CEA) on tumor cells and CD28 on T cells. Developed by Light Chain Bioscience, the molecule features monovalent CD28 engagement that is strictly dependent on the presence of CEA, thereby localizing T cell activation to the tumor microenvironment and reducing systemic toxicity. The Fc-domain of NI-3301 has been engineered to eliminate FcγR-binding while preserving neonatal Fc receptor (FcRn) engagement to maintain a favorable half-life. It is intended for use in CEA-positive solid tumors, potentially in combination with T cell retargeting bispecific antibodies or PD-1/PD-L1 checkpoint inhibitors to enhance anti-tumor efficacy.
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