The Heidelberg-based biotech company Affimed Therapeutics AG announced on 15th November 2010 that the first Hodgkin’s lymphoma patients have been treated with the AFM13 TandAb® antibody in a Phase I clinical study. Thus, the “first-in-man” tetravalent, bispecific antibody based on the company’s proprietary RECRUIT-TandAb® antibody technology has entered the clinic.
The Phase I repeat dose escalation study will enrol around 40 Hodgkin’s lymphoma patients at two centres in Europe and the USA. The first patients have already been treated with AFM13, Affimed’s lead product. These patients will receive a total of four doses at weekly intervals. The antibody was well tolerated in the initial dosing. Results from the trial will be available by Q4 2011.AFM13 is an innovative tetravalent, bispecific antibody based on Affimed’s proprietary RECRUIT-TandAb® technology. It binds the CD30 target molecule on the surface of Reed-Sternberg tumour cells and simultaneously activates natural killer cells (NK cells). Preclinical data suggest that RECRUIT-TandAbs® are able to identify and selectively destroy tumour cells in the human body. AFM13 has been granted Orphan Drug designation in Europe and the USA.The European and US Phase I study will primarily assess safety, tolerability and the pharmacokinetics of AFM13 and first indications of biological activity. The principal investigator in Europe is Prof. Dr. Andreas Engert, Chairman of the German Hodgkin Study Group and professor of internal medicine, haematology and oncology at the University Hospital of Cologne. The principal investigator in the US is Professor Dr. Anas Younes (Director, Clinical and Translational Research Program, Department of Lymphoma/Myeloma, Division of Cancer Medicine, M. D. Anderson Cancer Center, Houston).“With the clinical testing of the first TandAb® antibody, Affimed has achieved a very important milestone towards the clinical validation of our TandAb® platform”, said Dr. Rolf Günther, CEO of Affimed. “We are very happy that both the FDA and the Paul Ehrlich Institute supported our IND and CTA applications and look forward to advancing the treatment of Hodgkin’s lymphoma and other cancers by exploiting the unique advantages of our technology.”Professor Dr. Melvyn Little, CSO of Affimed added: “The application of tetravalent, bispecific antibodies to treat cancer is a first in humans and has the potential to create new and exciting treatment options for a wide range of diseases. TandAbs® are expected to have major advantages over first generation antibodies. Advanced Hodgkin’s lymphoma is a severe disease and there are only few treatment options available or in development.”