The role of Core D (Analytical and Animal Core) is to provide support to Projects 5, 6, 2, and 1 in three areas: 1) To perform in vitro assays for pre-clinical evaluation of antibody constructs and immunofusions developed in Project 2. These include: a) anti-CEA, anti-PSCA and anti-HER2 assays to assess immunoreactivity, b) IL-2 and gamma-interferon bioassays and elisa assays to characterize and assess functional activity of the immunofusions, and c) CEA immunohistochemistry of animal tumor samples. 2) To perform animal (murine) studies for pre-clinical evaluation of novel antibody bioengineered constructs, chelates, and peptide linkers developed in Projects 2 and 1. These include: a) biodistribution/imaging studies evaluating intermediate molecular weight constructs labeled with 131I, 111In, 124I and 64Cu; b) biodistribution studies evaluating novel chelates conjugated to anti-CEA antibody constructs labeled with 111In or 64Cu; c) studies evaluating biodistribution and functional activity of engineered immunofusion constructs (minibody-IL-2 and scFv-gamma-interferon immunofusions); d) studies evaluating the therapeutic effects of 90Y labeled constructs; and e) biodistribution studies of all clinical vialed lots of antibody prior to planned clinical trials. 3) to perform core studies on clinical samples obtained from patients entered on imaging and therapy trials in Projects 5 and 6. These studies include: a) 111In, 90Y and 123I, 124I and 64Cu counting of blood, urine, and tissue biopsy samples, b) 111In and 90Y counting of bone marrow samples, c) human anti-antibody and anti-idiotype assays on blood samples, and d) HPLC analysis of blood and urine samples.
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