European Regulatory Committee Recommends Orphan Drug Status for GPC Biotech's Anticancer Monoclonal Antibody
GPC Biotech AG announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) has recommended the granting of orphan medicinal product designation for the anticancer monoclonal antibody 1D09C3 for the treatment of multiple myeloma. The orphan drug status becomes effective when the European Commission has approved this recommendation. 1D09C3 is currently in a Phase 1 clinical program that is evaluating the antibody in patients with relapsed or refractory B-cell lymphomas, including Hodgkin's and non-Hodgkin's lymphomas, who have failed prior standard therapy.
1D09C3 is an anti-MHC (major histocompatibility complex) class II monoclonal antibody. 1D09C3 binds to MHC class II molecules on the cell surface and in preclinical studies appears to selectively kill activated, proliferating tumor cells, which include B-cell and T-cell lymphomas. In preclinical studies, 1D09C3 has been shown to induce programmed cell death and does not require a functioning immune system for its cell-killing effect. A Phase 1 clinical program evaluating 1D09C3 in patients with relapsed or refractory B-cell lymphomas who have failed prior standard therapy, is currently underway at several major cancer centers in Europe. 1D09C3 has been granted orphan medicinal product designation for the treatment of Hodgkin's lymphoma and chronic lymphocytic leukemia.
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