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Human Engineering™ (HE™) technology is a clinically-tested humanization method for reducing the immunogenicity of non-human antibodies, while still retaining the structural folding, antigen binding affinity, and functional potency of the parental antibody. XOMA’s HE™ technology is distinct from other antibody humanization techniques, is independent of CDR grafting, and is covered by multiple issued patents. HE™ technology is based on the conserved structure-function relationships among antibodies and defines which amino acid residues in a non-human antibody are candidates for substitution. Because no structural modeling or post-humanization adjustments are required, XOMA’s HE™ technology offers the dual advantages of speed and reliability relative to other humanization techniques. In a three-month timeframe, XOMA provides its partners with at least five milligrams each of four Human Engineered™ variants of the parental antibody, together with sequence and affinity characterization data for each antibody. Based on its 100% success rate in generating over 40 Human Engineered™ antibodies to more than 10 distinct targets to date, XOMA can state with confidence that the antigen binding affinity of the parental antibody will be retained within the range of measurement uncertainty for affinity characterization techniques. Human Engineered™ antibodies have been administered to humans in clinical trials, with no reported cases of an antibody response at or above the FDA-recommended level of assay sensitivity.
XOMA provides access to its HE™ technology, related expertise and know-how through service and partnership agreements. XOMA can provide its partners and licensees with a number of options and deliverables according to their program objectives. In addition to its HE™ technology, XOMA also offers a range of other fully integrated capabilities for accelerating its partners’ antibody development programs, including cell line development, process scale-up, and manufacturing of clinical material in a cGMP facility licensed for both the U.S. and Europe. |