Soluble engineered monomeric fc
AssigneeThe United States of America, as represented by the Secretary, Department of Health and Human Serv
InventorsDimiter S. Dimitrov, Tianlei Ying
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Abstract
Fc domains and CH3 domains are disclosed that bind the neonatal Fc (FcRn) receptor and are at least 99% monomeric. Monomeric Fc domain molecules and CH3 domain molecules are disclosed herein that include a monomeric Fc domain or a monomeric CH3 domain and an effector molecule. In some embodiments, the monomeric Fc or monomeric CH3 domain include amino acid substitutions and/or CDR insertions in the beta strands such that they specifically bind an antigen. Methods for using these monomeric Fc domains, monomeric CH3 domains, monomeric Fc domain molecules and CH3 domain molecules are also provided.
Claims23
A monomeric Fc domain comprising a CH2 domain and a CH3 domain, wherein the monomeric Fc domain specifically binds an antigen;
- wherein (i) the CH2 domain and the CH3 domain both comprise beta strands, and at least one of the beta strands of the CH2 or CH3 domain is mutated;
- and/or wherein (ii) at least a portion of the CH2 domain or a portion of the CH3 domain is replaced by a complementarity determining region (CDR), or a specificity determining region (SDR), from a heterologous immunoglobulin variable domain that specifically binds the antigen;
- or (iii) both (i) and (ii);
- wherein the polypeptide has a molecular weight of less than about 30 kD;
- and
- wherein the monomeric Fc domain binds the neonatal Fc receptor.
Dependencies are inferred from the claim text.