EMEA recommends OD status for GPC Biotech monoclonal antibody

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 Hodgkin's lymphoma.

The orphan drug status becomes effective when the EC has approved this recommendation. 1D09C3 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 EMEA's orphan drug programme 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.

About 1D09C3

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 tumour 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. A Phase I clinical study evaluating 1D09C3 in patients with relapsed or refractory B-cell lymphomas, such as Hodgkin's and non-Hodgkin's lymphomas, who have failed prior standard therapy is currently underway