Orphan drug designation is awarded to potential treatments for rare and very serious conditions. The designation confers certain benefits such as market exclusivity for up to ten years in the given indication and help with the regulatory process.
1D09C3 is currently in a phase I 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 (CLL), 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 surface of cells and selectively kills activated, proliferating tumor cells, which include B-cell and T-cell lymphomas.
In 2004, it was estimated that more than 54,000 people in the US and about 64,000 people in the European Union were diagnosed with non-Hodgkin’s lymphoma, the most common form of lymphoma.