Innovative immunotherapies have the potential to effectively support the human immune system in its fight against tumours. However, the transfer of knowledge obtained from basic research into clinical application takes a long time, is costly and has to overcome many regulatory hurdles. With the establishment of the Center for Translational Immunology (TransLimm), the University of Tübingen has initiated a network whose objective is to quickly and effectively transfer innovative therapies into clinical application. Patients suffering from acute leukaemia might soon benefit from therapies involving antibodies optimized by recombinant antibody technology.
Antibodies, natural killer cells, T-lymphocytes – the human immune system has a plethora of weapons at its disposal to combat infectious pathogens as well as abnormal body cells. However, cancer cells always find new molecular loopholes that enable them to escape destruction by the body’s immune cells. Innovative immunotherapies have been developed to effectively support the human immune system in its fight against tumours. Antibodies optimized by recombinant antibody technology that have been developed by Professor Dr. med. Gundram Jung from the Department of Immunology at the University of Tübingen are one such beacon of hope. “We are able to increase the efficiency of antibodies, which are big protein molecules, by applying some genetic engineering tricks. We can either exchange individual amino acids or we can construct double-duty antibodies that are not only able to recognize tumour cells, but which can also specifically activate immune cells,” said Gundram Jung explaining the principle of his work. Gundram Jung, who heads up the Section of Experimental Antibody Therapy at the Department of Immunology, has recently tested the effect of an antibody of this kind on leukaemia patients and has come up with promising results.
“We are hoping that this antibody will help us to reduce by around 50 per cent the relapse rate of tumours in patients who have undergone chemotherapy treatment,” explained the researcher. This would be a new milestone on the path to developing effective anti-tumour therapies, especially given that the modified antibodies have not led to any noteworthy effects in the patients treated so far. A larger clinical trial, to be carried out in cooperation with the University of Tübingen, is planned for early 2012.The fact that the researchers will be able to carry out a clinical trial as early as 2012 is also down to the Center for Translational Immunology (TransLimm) which was established on the initiative of Professor Dr. Hans-Georg Rammensee, Director of the Department of Immunology at the University of Tübingen. This network, which brings together basic researchers, clinicians and regional biotechnology companies, aims to make a significant contribution to applied medicine by turning research results into innovative drugs and novel vaccines for the treatment of cancer and immune diseases faster and more effectively than before. “This type of cooperation is unique in Europe,” said Jung who is aware of the advantages of being located in Tübingen. “Here in Tübingen, we benefit from excellent conditions in that outstanding basic research and innovative clinical research are carried out in close physical proximity to each other.”
The Center for Good Manufacturing Practice (“GMP Center”) at the University Hospital of Tübingen which was officially opened in summer 2010 is the core of the new network. The GMP Center can be used to produce in accordance with good manufacturing practice (GMP) the antibodies developed by Gundram Jung and his team, as well as patient-individual vaccines for cancer treatment that have been developed by a team of researchers led by Professor Rammensee and Professor Stefan Stevanovic at the Department of Immunology. Following the much stricter regulations that have been put in place, the new GMP facility became necessary. “These regulations have made it nearly impossible to carry out clinical trials at universities,” said Jung who makes no secret of the fact that he believes that many of the regulatory requirements are exaggerated. “There is no doubt that we need regulatory guidelines to ensure that drugs are produced in accordance with standards that safeguard people’s health. However, I believe that we should differentiate between vaccines that are used to vaccinate millions of healthy people and experimental drugs that are designed to treat only a few, severely sick patients for whom no satisfactory treatment is otherwise available,” said Jung pointing out that animal testing, including drug safety testing involving apes, is still a core element in pharmaceutical R&D. “I do not think that animal testing is appropriate in all cases. Many biological drugs that are designed to treat humans have completely different, or no effect in animals. This process delays drug development, as well as making it more costly,” said Jung pointing out that in contrast to Europe, the regulatory authorities in the USA have already realized that the two types of medicine should be treated in different ways and have consequently put rules in place that take this into account.
New drugs and therapies are desperately needed in the fight against cancer. “I do not think that the majority of cytostatic drugs that will be discovered in the future will be a great deal better than those we are using at the moment,” said Jung calling for innovative approaches. He also believes that academic institutions should increasingly focus on the development of innovative medicines, as any decision made by a pharmaceutical company needs to take economic aspects into account. “I believe that academic institutions should be able to provide the pharmaceutical industry with fully-shaped concepts for the development of marketable drugs,” said the renowned immunologist who was also a clinical physician for many years.Gundram Jung is hoping to achieve this goal with his innovative anti-tumour antibodies. He is supported in his efforts by the German Ministry of Education and Research’s (BMBF) GO-Bio programme, which enables successful participants to move into a second funding phase where they will receive funding to establish a new company. Jung’s group of researchers was granted funding to establish a company called Synimmune GmbH, which will now take the development of antibodies to the stage of clinical Phase II studies, in close cooperation with the University of Tübingen. Optimized antibodies with proven clinical efficiency will then be developed further in cooperation with the pharmaceutical industry. Gundram Jung: “Once we have reached this stage, we depend on the cooperation of the pharmaceutical industry. We will at some stage need to produce antibodies for as many as 100 patients or more, and the GMP Center in Tübingen is unfortunately not designed for the production of such large numbers of antibodies.”
Further information:Prof. Dr. Gundram JungUniversity of Tübingen Dept. of ImmunologySection of Experimental Antibody TherapyAuf der Morgenstelle 15D-72076 Tübingen