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CEO Perspective: Prof. Dr. Dolores Schendel, Medigene AG

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Perspectives from Leaders in Immuno-Oncology

Professor_Dolores_SchendelMedigene AG is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative, complementary treatment platforms to target various types and stages of cancer with candidates in clinical and pre-clinical development.  Medigene concentrates on the development of personalized T cell-based immunotherapies.

In February Coulter:Pulse interviewed Prof. Dr. Dolores Schendel, CEO/CSO of Medigene AG.

Coulter:Pulse – What do you see as the defining moments in your own career that have led you to this exciting point, leading Medigene’s strategy in Immuno-Oncology?

Prof. Schendel: I started my career working within animal models and decided to translate this expertise to the field of human cellular immunology. I came to Germany to help set up a research group around bone marrow transplantation. This was really a defining moment for me, when I started to think about the combination of cellular therapies in that setting and the thread has continued right up to the present as CEO of Medigene, where our emphasis is on haematological malignancies. In this area immunotherapies can meet a real and unmet need.

Following a Professorship at Ludwig-Maximilians-University, Munich, I was appointed a director of the Institute of Molecular Immunology at the Helmholtz Centre – the German Research Centre for Environmental Health. Here our research was much more applied and our rationale revolved around the question:

“What are we doing in research that will lead to definitive patient benefit?”

More resources came with the role and allowed us to establish research around a core of technologies needed to move into immunotherapies and to tune our experiments in a practical dimension. We built a monitoring system to characterise immune responses and set up a pre-GMP development group to take what we did in the lab on a small scale, experimentally, and determine how it would be possible to translate this from the research arena into drug candidates for patients.

Over 13 years I was able to build a highly skilled team of scientists but as we weren’t a clinic it was difficult to get funding in Germany for clinical trials (In the US for instance this is much easier through the NIH). Here only a few exceptional trials find funding and one may only see 1 or 2 in one’s entire career. We were granted permission to take one programme – a dendritic vaccine – to academic trial.

This became another critical moment in my career.

Once we thought we could deliver in terms of a viable product for patients, I realised that to access the money and resources needed to take things further into clinical development, I would have to spin out, establish a business and attract investment. So Trianta Immunotherapies was founded on our academic research at the Helmholtz National Research institute.

To ensure the future of such a start up in immunotherapy I needed to decide how to structure and fund the programme. I was put in touch with the BioM Cluster, an organisation in Munich to connect academics, Pharma and Biotech. With a view to setting up clinical trials, I was introduced to Medigene, one of the oldest biotechs in Germany founded in 1994 on their research in gene therapy.

Not only was Medigene situated just down the road, they had a perfect infrastructure with 3 whole floors of fully equipped laboratories, requiring only minimal additional technology. Medigene then acquired Trianta and I was able to take my whole team along with me! This was a crowning moment for me to see all the young scientists, post-doctorates and technicians happily installed here. It meant that within months we were up and running as a fully functioning Biopharma company.

Everything was optimal. In addition to the Munich location, we now had expertise on hand in clinical development, GMP manufacturing, regulatory and medical affairs, and marketing; there was IP infrastructure, a lead team, R&D focus, financial knowhow and access to the stock market. Medigene benefited from a ready-made in-house development programme built on a strong R&D team led by me as CSO. Their longer term goal to reperfuse their existing drug pipeline with immunotherapy candidates could now be fulfilled.

My role was to transition the company and move away from their old model of bringing in single and sometimes unrelated products, by streamlining the licensing out or selling of such legacy products, in order to develop a new focus on Immuno-oncology. Following management structure changes last year, I was appointed CEO on 1st February 2016.

This was a remarkable transition for me.

Coulter:Pulse – That must have been a very special moment for you. Please can you tell us more about Medigene’s particular focus in the IO field and the opportunities here?

Prof. Schendel: Medigene’s core business is in immuno-oncology and cellular immunotherapies, with a particular emphasis on personalised T-cell based immunotherapies. There are many exciting opportunities and challenges in this area.

For a long time it was really academicians who had kept immune-oncology alive. Pharmaceutical companies were not interested because of the complexity. Working with cells from patients was anathema to them and there was no interest in individualised drugs. The impulse that subsequently helped to create more interest really came from regenerative medicine. Building organs such as knees and heart valves opened up the thinking about individualised cellular patient therapies. Therein lay a solution to many health problems and so a pathway needed to be found.

Immunotherapies started to show strong results.  People started to sit up and take notice. Consequently there was a paradigm shift. The focus in oncology moved away from radiation, chemotherapy and small molecules directed at the tumour to immunotherapies directed at modulating the immune system. Now there was more than one pathway to control cancer – interactive, complementary approaches which could be aligned in the future. The major challenge was to develop these economically and efficiently.

The overall rationale now for cancer patients is to extend life not just by 6 weeks or 4 months, but by 1, 2, 4 or maybe more years. Early patients with haematological malignancies are now able to envision eradicating the disease completely. As with successful transplant patients, a lifetime free from the recurrence of leukaemia or lymphoma is now feasible. And there is now increased hope for those unsuitable for bone marrow transplantation.

Now that some of these immunotherapies are likely to become a real part of patient care there is an opportunity for Medical Device companies to get involved. There is a significant business opportunity for them to help automate/robotise production in this field and get on board the development of cellular therapies. They can bring co-development into play to help identify the technology to use and reduce costs. Once the biotechs have shown strong clinical benefit, the next challenge is how to produce and market to a large number of patients. Clinical trials are smaller for these therapies on the whole. Faster trials and results will drive FDA and European regulators to fast track regulatory developments in a shorter time frame.

Coulter:Pulse  – Please can you tell us about Medigene’s particular approach and how it is  differentiated from that of other players in IO?

lab_sceneProf. Schendel: With Medigene’s most advanced platform we develop new generation antigen-tailored dendritic cell (DC) vaccines.  Dendritic cells can take up antigens efficiently, process them and present them on their surface in a form that can induce antigen-specific T cells to proliferate and mature.  This way T cells can recognise and eliminate antigen-bearing tumour cells.  Dendritic cells can also induce natural killer cells (NK cells) to become active and attack tumour cells.  Our team has developed new, fast and efficient methods for generating autologous (patient-specific) mature dendritic cells which have relevant characteristics to activate both T cells and NK cells.  The dendritic cells can be loaded with various tumour antigens to treat different types of cancer.

Medigene’s DC vaccines are in development for the treatment of minimal residual disease or use in combination therapies.

Medigene’s technology for T cell receptor modified T cells is the company’s other main immunotherapy platform. It is a highly innovative and complementary for adoptive T cell therapy and is suited for the treatment of advanced cancer.  This second platform aims to arm the patient’s own T cells with tumour-specific T cell receptors.  The receptor-modified T cells are then able to detect and efficiently kill tumour cells.  This form of immunotherapy aims to overcome the patient’s tolerance to cancer cells, and the tumour-induced immunosuppression in the patient, by activating and modifying the patient’s T cells outside the body (ex vivo).  In this case, a large number of specific T cells to fight the tumour can be made available to patients within a short period of time.

In the case of rampant tumours with a high burden, one cannot vaccinate to get an immune response. So T-cells can be made outside the body and given a preselected T-cell receptor. This Adoptive T-cell therapy can eradicate tumour loads as heavy as 1 kilo. Our third product platform serves to generate monoclonal antibodies which are able to recognise different T cells (TABs = T cell-specific AntiBodies). These TABs are intended to remove unwanted T cells from the body in order to treat T cell-induced diseases such as various T-cell leukaemias. This platform is used to produce and characterise monoclonal antibodies which are able to distinguish between different T cells. Proof of technology was established in preclinical experiments.

Another opportunity we have is to use human genomes and mutations that occur, in order to identify changes in precursor lesions that could indicate the potential future development of leukaemia. A prophylactic vaccine could then be produced to try to eliminate precursor cells before they become a leukaemia.

Coulter: Pulse – How important is the “human element” – i.e. the right talent – in driving your programme forward?

Prof. Schendel: While of course scientists – so cellular immunologists – are required to drive this sort of programme, people who understand regulatory and medical affairs are also vital to its success; and those with expertise around clinical trials, because this is not just a single drug sitting on a shelf. A production process that is robust and GMP compliant is required and the sophisticated expertise to gather and move samples safely around, for instance. A strong track record in developing these sorts of therapies is highly sought after and in short supply. Clinical results are driving this field and as long as these reflect the sorts of enormous clinical benefit we are seeing, then new talent will be attracted into this area.

To help us achieve our goal to become a leading player in the highly-competitive and fast-moving immunotherapy area, we recently worked with Coulter Partners to appoint an SVP Research & Pre-Clinical Development.  Coulter Partners conducted a global search, focusing on the identification of outstanding scientific leaders with experience in the discovery and early phase development of oncology products, with a focus on cancer immunology.  The appointed candidate, Dr. Markus Dangl took up his new position as Senior Vice President Research & Pre-Clinical Development at Medigene AG on 1 March 2016. He brings deep knowledge in successfully leading multidisciplinary oncology research and translational medicine teams as well as managing external collaborations. Dr. Dangl held leading positions at Roche in the past 14 years, including the establishment of the Roche Translational Medicine Hub in Singapore where he was responsible for all research and translational medicine activities.

We were delighted to attract such a high calibre international player in the pharma and life science sector to join us at Medigene and I would like to thank everyone on the search team at Coulter Partners for their highly professional service. Dr. Dangl brings a unique set of skills and a wealth of experience to foster our next phase of clinical and commercial development. To guide the move from deep science to complicated drug delivery will take not only plenty of wisdom but also a good deal of entrepreneurial spirit.

 
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