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QLS2401 is a novel tri-specific T-cell engager (TCE) designed to target both Prostate-Specific Membrane Antigen (PSMA) and Six Transmembrane Epithelial Antigens of the Prostate 1 (STEAP1) on tumor cells, while simultaneously engaging CD3 on T cells. Developed by Qilu Pharmaceutical, it is intended for the treatment of metastatic castration-resistant prostate cancer (mCRPC). By dual-targeting PSMA and STEAP1, QLS2401 aims to enhance T cell-mediated cytotoxicity and mitigate potential resistance mechanisms associated with single-antigen loss. Preclinical studies have demonstrated that QLS2401 exhibits potent target-dependent cytotoxicity against prostate cancer cell lines and induces tumor regression in xenograft models. Furthermore, it has shown a superior therapeutic window and improved tolerability in cynomolgus monkey toxicity studies compared to xaluritamig analogs.
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