A development project from Synimmune GmbH, founded in July 2010, made a big impression on the panel of assessors at the German Federal Ministry of Education and Research (BMBF). So much so, that the company was awarded EUR 2.5 million as part of the GO-Bio biotechnology start-up scheme.
This is more than 50 % of the sum the company will need in the next three years. The rest must be provided by external investors, some of which have already committed themselves to the project. The Tübingen-based biotech company develops genetically enhanced antibodies to fight cancer, produces these in a university-owned facility and also conducts early clinical trials in close cooperation with the University of Tübingen. The concept of working so closely with a university – covering all stages from developing the antibodies right up to initial clinical studies – is unique in Europe and aims to speed up the process of getting new cancer drugs from laboratory to hospital. Launched in 2005, GO-Bio supports research teams wishing to go into business in the field of life sciences with a view to “developing technically demanding ideas into commercially successful business start-ups”, according to the BMBF.
In order to find successful applications for the first-generation monoclonal mouse antibodies developed to treat cancer in the 1970s, biotechnological processes to humanise these antibodies have been in development since the 1990s. These second-generation antibodies are able to activate the body’s own immune cells to fight tumour cells. Such substances have led to significant progress in the treatment of cancer in recent years. However, therapeutic effectiveness is often limited as the immune system does not respond sufficiently to the antibodies. Synimmune GmbH, a biotech company established by researchers from the University of Tübingen, is therefore looking to develop a third generation of antitumour antibodies with heightened effectiveness. “We are using a genetic procedure which dramatically increases the ability of humanised antibodies to activate certain immune cells”, explains Dr. Ludger Grosse-Hovest, one of the founders and CEO of Synimmune. “Only two of the many hundreds of building blocks (amino acids) of the antibody molecule are altered in this process. The first antibody Synimmune optimised in this way is designed to combat certain forms of leukaemia.”Parallel to producing genetically enhanced monospecific antibodies, Synimmune is also working on producing so-called bispecific antibodies using complex genetic processes. Unlike “normal” antibodies, these have not just one but two binding specificities. “One binding arm targets the tumour cells as with normal cancer antibodies while the other ensures that immune cells such as T cells are activated to target tumour cells”, explains Prof. Gundram Jung, the “founding father” of the new company. “We believe that bispecific antibodies could revolutionise the antibody treatment of cancer. The downside is that they are much more difficult to produce than the monospecific antibodies currently in use.”A unit equipped to industrial quality standards has been set up to produce antibodies at the Tübingen Centre for Clinical Transfusion Medicine. This is the first time a university research group in Germany has successfully produced antibodies in line with international pharmaceutical standards, i.e. in a quantity and quality deemed suitable for human use. Until now, only big pharmaceutical companies have been able to produce antibodies under Good Manufacturing Practice (GMP) conditions. “Because everything happens under one roof here, our enhanced antibodies reach patients more quickly”, explains Dr. Grosse-Hovest. Instead of the development and approval time of around seven years usual in the pharmaceutical industry, Synimmune is hoping to develop new antitumour antibodies in just three years. The pharmaceutical-quality antibodies will then be tested in initial clinical trials at the University Hospital Tübingen.Dr. Steffen Aulwurm, the second CEO of Synimmune GmbH and the man in charge of antibody production, uses a new procedure for GMP production where the antibodies are fermented in cell cultures in a wave reactor. “Cells grow particularly well in this reactor thanks to its simulated wave movements and low mechanical loading”, explains Dr. Aulwurm. “We produced and purified a total of 25 grammes of antibodies in our initial production run using the 100-litre wave reactor. That is a relatively large amount, which could be used to treat more than 100 patients.”“The panel of assessors for the BMBF GO-Bio competition was impressed by the idea of a biotech company working in close conjunction with a university to carry out the entire development process for enhanced antitumour antibodies – from the actual development through production right up to phase I/II studies. Hence their decision to sponsor us”, says Prof. Jung, whose medical background ensures close ties with the University Hospital. “The perfect conditions and close proximity involved are key to our success.” Dr. Klaus Eichenberg, Managing Director of BioRegio STERN Management GmbH, is impressed: “If the concept of developing antibodies under independent GMP conditions in conjunction with a university is successful, it could provide inspiration for other universities and researchers looking to go into business. We are delighted to lend our support to this innovative company as part of our Science2Start programme.”Synimmune GmbH initially plans to employ ten staff. “We are not trying to establish ourselves as a large pharmaceutical company”, says Prof. Jung. “Our aim is to bring the antibodies through clinical phase I or phase II studies. After that, we are dependent on cooperation with the pharmaceutical industry.”