GPC Biotech's 1D09C3 receives orphan drug status for chronic lymphocytic leukemia in Europe

By E. Janene Geiss

Philadelphia, Jan. 27 - GPC Biotech AG announced Friday that the European Commission has granted orphan drug designation for the anticancer monoclonal antibody 1D09C3 for the treatment of chronic lymphocytic leukemia. 1D09C3 is in a phase 1 clinical trial that is evaluating the antibody in patients with relapsed or refractory B-cell lymphomas, such as Hodgkin's and non-Hodgkin's lymphomas including chronic lymphocytic leukemia, who have failed prior standard therapy, according to a company news release.

The orphan drug program of the European Medicines Agency is designed to promote the development of drugs to treat rare, life-threatening or very serious conditions that affect no more than five in every 10,000 people in the European Union, officials said.

The designation provides E.U. market exclusivity for up to 10 years in the given indication. Other potential benefits include a reduction in fees associated with various aspects of the regulatory process, including the application for marketing approval and guidance in preparing a dossier for marketing approval, officials said.

1D09C3 is an anti-MHC (major histocompatibility complex) class II monoclonal antibody. It binds to MHC class II molecules on the cell surface and selectively kills 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 major cancer centers in Europe.

1D09C3 has also been granted orphan medicinal product designation for the treatment of Hodgkin's lymphoma.

GPC Biotech is a Munich, Germany, biopharmaceutical company discovering and developing new anticancer drugs.

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