GPC Biotech product recommended for orphan drug status

The Committee for Orphan Medicinal Products (COMP) at the European Agency recommended orphan status for the anticancer monoclonal antibody 1D09C3. The orphan drug status would become effective following approval by the European Commission.

The drug is currently in a phase I clinical trial 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.

The European Medicines Agency’s orphan drug program 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 (EU). The designation provides EU market exclusivity for up to ten 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 EMEA guidance in preparing protocols concerning studies relevant for approval.

1D09C3 is an anti-MHC (major histocompatibility complex) class II monoclonal antibody. 1D09C3 binds to certain cell surface receptors, selectively killing activated, proliferating MHC class II-positive tumor cells, which include those in B-cell and T-cell lymphomas. 1D09C3 has been shown to induce programmed cell death and does not require a functioning immune system for its cell-killing effect.