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This investigational biologic is a monovalent, long-acting antibody fragment (Fab) targeting the CD40 receptor, developed by a research consortium led by XL-protein in collaboration with Wacker Chemie and Ludwig-Maximilians-Universität München (LMU). The drug is designed to block the CD40–CD40L costimulatory signaling pathway, which is a critical driver of immune-mediated organ rejection. It utilizes XL-protein's proprietary PASylation technology, which involves the genetic fusion of a conformationally disordered polypeptide composed of proline, alanine, and serine (PAS) to the antibody fragment. This modification increases the drug's hydrodynamic volume, thereby extending its plasma half-life and potentially improving patient safety compared to traditional PEGylation. The primary indication under investigation is immunosuppression for cardiac xenotransplantation (pig-to-human heart transplants), with potential broader applications in conventional organ transplantation and autoimmune diseases. Manufacturing is supported by Wacker's ESETEC secretion technology.
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