Patent ID: 8470542
Filing Date: 2013-06-25
Classification: A61P,C07K,C12Q,G01N

Abstract:
1. A method for determining whether a subject with a Her-2 positive cancer is likely to respond to treatment with a Her-2 pathway targeted therapy, comprising the steps of: (a) measuring the amount of a p95Her-2 protein fragment having a first amino acid corresponding to methionine 611 of Her-2 protein in a biological sample of the subject's cancer using a p95Her-2-specific antibody raised against a peptide having a sequence as set forth in SEQ ID NO:5 and produced by a hybridoma cell line selected from the group consisting of hybridoma cell lines having ATCC accession number PTA-9738 (p95.D3.4), PTA-9739 (p95.D8.2), and PTA-9740 (p95.D9.1); (b) determining whether the amount of p95Her-2 in the subject's sample is below a p95Her-2 cutoff, wherein the p95Her-2 cutoff comprises at least one of (i) a level of p95Her-2 expression at least two-fold greater than control cancer cells lines having basal levels of p95Her-2 expression or (ii) a level of p95Her-2 expression corresponding to at least a top 30 (c) indicating that the subject is more likely to respond to a Her-2 pathway targeted therapy targeted to the extracellular domain of Her-2 if the amount of p95Her-2 in the biological sample is below the p95Her-2 cutoff as compared to if the p95Her-2 in the biological sample is above the p95Her-2 cutoff.