Affimed's lead product for Hodgkin's Disease is a bispecific TandAb: AFM13. AFM13 binds specifically to CD30, a protein which is mainly expressed on Hodgkin tumor cells (e.g. Reed-Sternberg cells) in cases of Hodgkin's Disease, and to CD16 surface receptors on Natural Killer (NK) cells in order to induce cell lysis. In this way, AFM13 causes selective destruction of the Hodgkin's tumor cells through antibody dependent cell mediated cytotoxicity (ADCC).
Hodgkin's Disease
Hodgkin's Disease is a cancer of the lymph nodes with disease progression characterized by orderly spread from one lymph node group to another ultimately resulting in the development of systemic symptoms. As distinct from Non-Hodgkin's Lymphoma, the disease is characterized by the presence of Reed-Sternberg cells. Fortunately, this disease can be successfully treated in the majority of cases with chemotherapy combined, where necessary, with radiotherapy. Approximately 84% of the patients respond to the therapeutic regimens, and 48% show a long term remission of up to 15 years. However, due to the many side effects in conventional chemotherapy and radiation, there is a high unmet medical need for medications which significantly improve treatment and which have a more selective mechanism of action in order to prolong a patient's lifetime and the quality of life. In addition, a significant number of patients treated with chemotherapy and radiation experience a remission of the disease. About 52% experience a relapse after initial treatment. The majority of relapses occur within 2 years if initial treatment with a maximum between 12-18 months.
Preclinical results
In vivo studies have indicated that AFM13 effects a significant regression of a human Hodgkin's tumor. AFM13 also displayed significantly more in vitro activity than a precursor Diabody, which in spite of its relatively small size, caused a significant tumor regression in a SCID mouse xenograft.
Clinical trials
On completion of preclinical studies, Affimed intends to take this product in to the clinic.