Affimed Therapeutics AG announced today that the US Food and Drug Administration (FDA) has granted orphan drug designation to the human recombinant antibody AFM13 for the treatment of Hodgkin lymphoma. The designation entitles Affimed to seven-year market exclusivity in the US upon approval of this drug candidate. AFM13 is a novel, bispecific antibody based on Affimed's proprietary TandAb technology.
TandAbs are tetravalent antibodies characterized by their ability to identify and selectively destroy tumour cells in the human body by binding target molecules on the surface of tumour cells and activating T-cells or natural killer cells (NK cells) simultaneously. Preclinical data has shown promising evidence for the efficacy of AFM13 in Hodgkin lymphoma. The initiation of the first clinical studies is expected to start in the first quarter of 2010.Dr. Rolf Günther, CEO of Affimed, commented: "Our promising preclinical data with AFM 13 convinced the FDA experts of the strong potential of our TandAb technology for the treatment of relapsed or refractory Hodgkin lymphoma where only limited treatment options exist. The positive decision on the part of the regulatory authority confirms the great, unmet medical need for new therapeutic approaches in this indication. Up to 10.000 people could benefit from those new therapies in the US approximately per year. Given the planned initiation of the first clinical trials with AFM 13 in the beginning of 2010, the orphan drug designation is a very important signal for the further successful global development of our lead product."