Because of the strong translational orientation of the Section it is active in all three areas of the translational process for therapeutic antibodies: (A) Development and preclinical characterization (B) GMP-compliant production and (C) Evaluation of therapeutic activity in informative clinical pilot trials.
Recombinant antibody technology is of paramount importance for the development of innovative therapeutic antibodies Thus, an identically named research group headed by Ludger Große-Hovest has been established within the Section.
Currently, we focus our research activities on four different lines of antibody development
1) monospecific antitumor antibodies with improved Fc function
2) bispecific antibodies mediating selective T cell activation
3) improved antibodies directed against tumor vasculature
4) bispecific antibodies that selectively stimulate death receptors
In general, universities are well equipped for the development of innovative biologicals and have direct patient access. However, GMP compliant production remains a formidable challenge and a bottleneck for a university driven translational process. The production group within the Section, headed by Steffen Aulwurm, is now located within a newly constructed GMP building at the Institute for Transfusion Medicine. The group has managed within two years to establish the GMP compliant production of an optimized FLT3 antibody for the treatment of patients with acute myeloid leukaemia.
It is part of our translational concept to design studies which allow a rapid evaluation of the therapeutic activity of a newly developed antibody. Currently, we perform compassionate need applications of the FLT3 antibody mentioned above in cooperation with the Department of Internal Medicine II (Helmut Salih, Lothar Kanz). A Phase I study is planned to start in the second half of 2011.
View from the Department of Immunology to the Center of Clinical Transfusion Medicine and the Department of Medical Oncology where production and clinical evaluation of optimized antitumor antibodies are performed. Initial antibody development at academic institutions will help to improve the quality and speed of this process.
Tumor cells coated with bispecific antibodies are attacked and killed by activated T-cells (Photo. J.Chiu, G.Jung).