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news.GPC Biotech AG has initiated a phase I human clinical study with its anticancer monoclonal antibody, 1D09C3, which will be the company's first internal R&D anticancer program to enter human clinical testing.
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The study is an open label, phase I study that is evaluating 1D09C3 in patients with relapsed or refractory B-cell lymphomas who have failed prior standard therapy. The goal of the study is to determine the safety and tolerance of the antibody in patients and to recommend a dose and schedule for subsequent phase II studies.
The phase I study program will involve major academic centers in Switzerland, Germany and Italy. The Swiss site, where the study has now been initiated, is the Oncology Institute of Southern Switzerland (IOSI), a world-renowned oncology center that has been involved in numerous previous phase I studies.
“We are excited about the novel mechanism of action of 1D09C3, which is distinct from the mechanisms of action of the products currently used for the treatment of lymphoid tumors,” commented Dr Marcel Rozencweig, senior vice president of drug development at GPC Biotech.
The 1D09C3 antibody was isolated in collaboration with MorphoSys from its HuCAL library of human antibodies. It has been shown to induce programmed cell death and does not require a functioning immune system for its cell-killing effect.