Protecting compromised immune systems - the life-saving innovation that fights dangerous viruses

(f.l.t.r.) Dr. rer. nat. Holger Zimmermann, Prof. Dr. rer. nat. Helga Rübsamen-Schaeff

Prof. Dr. rer. nat.
Helga Rübsamen-Schaeff (Spokesperson)
Dr. rer. nat. Holger Zimmermann

AiCuris Anti-infective Cures GmbH, Wuppertal

Many people carry a dangerous virus without ever being aware of it. It is usually kept at bay by the body's own defenses. Yet when the immune system is weakened, as it is following an organ transplant, the pathogens can gain the upper hand - and cause life-threatening conditions. Is there any way to prevent this often fatal risk?

Prof. Dr. rer. nat. Helga Rübsamen-Schaeff and Dr. rer. nat. Holger Zimmermann have succeeded for the first time in locating a novel mechanism of action that effectively protects humans from attacks by the human cytomegalovirus (CMV). In a newly founded company, the nominees developed a drug with the substance that will open up new prospects in transplant medicine. It has recently been approved for patients who need to undergo bone morrow transplants. Helga Rübsamen-Schaeff founded AiCuris Anti-Infective Cures GmbH in 2006 and served as Managing Director until 2015. She is currently a Chair of the Scientific Advisory Board. Holger Zimmermann is CEO of the Wuppertal-based company.

For many leukemia patients who have not been helped by other forms of treatment such as chemotherapy, a bone marrow transplant is often their last hope for recovery. Their own cells or the bone marrow of a suitable donor are transplanted. To ensure that the cancer cells are destroyed, doctors first destroy the recipient's own bone marrow. This effectively switches off the immune defenses for a certain amount of time. This then becomes the perfect environment for the human cytomegalovirus (CMV): the pathogen that belongs to the family of the herpes virus can be found in one of two people in industrial nations. They usually have no opportunity to cause trouble. Yet if the immune system is compromised, they may begin to wreak havoc. In transplant patients, this results in severe rejection reactions, organ damage, and in the worst case, even death. There are drugs to prevent an infection with the dangerous pathogens that are commonly administered after a bone marrow transplant. These, however, often have severe side effects and can thus not be used as a means of prevention.

The nominees, however, have discovered a way for the first time to prevent side effects and infection. They identified a completely new mechanism of action, letermovir, that belongs to a different chemical class than the substances previously used to combat CMV infections and whose mode of action is thus based on a completely different principle. It is thus not a further development, but - unlike conventional drugs - attacks a virus structure for which there is no equivalent in the human body. This prevents side effects and makes the drug well tolerated. Because the active ingredient attacks the human cytomegalovirus directly, it can prevent its spread throughout the body.

Originally, the nominees intended to develop a new drug at Bayer AG based on the novel substance. The pharmaceutical group, however, stopped its activities in infection research soon thereafter. The scientists working with Prof. Rübsamen-Schaeff overcame this challenge by founding the company AiCuris in 2006 together with several former Bayer employees and supported by investors. They continued working on the drug - until the decisive clinical test Phase III. For this last clinical test, the young pharmaceutical company concluded a strategic partnership with the American company Merck Sharp & Dohme (MSD). In the meantime, the final study has been completed and the drug has been put on the market under the name PrevymisTM. To date, it has been approved for use in the EU, Switzerland, the USA, Canada and Japan - to prevent possible infection with CMV for bone marrow transplant patients. For recipients of bone marrow donations, PrevymisTM is the only drug to prevent infections effectively; all competing developments were aborted during the clinical test phase.

The drug's potential is immense since the number of bone marrow transplants is steadily increasing worldwide. Over 60,000 bone marrow transplants take place per year of which around 40,000 are at risk due to the virus. Additional applications could follow in the future. The human cytomegalovirus is a threat to anyone who carries the pathogen and has an immunodeficiency, such as AIDS patients, newborns or recipients of donor organs. MSD further launched a study on the use of the drug during kidney transplants in 2018. If it proves successful, the drug could be approved for this application as of 2022.

The drug which heralds a paradigm shift in transplant medicine is marketed by Merck Sharp & Dohme. AiCuris shares in the sales which continue to increase in the few months since the product's launch and already amounts to almost € 5m per month. AiCuris also receives milestone payments. The company has already received € 260m and holds an option for the joint marketing of the drug with MSD in several European countries. Revenue already accounts for the positive company balance sheet and is to be used to develop additional promising potential drug candidates. Additional new jobs have already been created at the Wuppertal location. The success is also a definite signal to the German biopharmaceutical industry that innovative medial developments from Germany once again have good prospects internationally.

The right to nominate outstanding achievements for the Deutscher Zukunftspreis is incumbent on leading German institutions in science and industry as well as foundations.
The project "Protecting compromised immune systems - the life-saving innovation that fights dangerous viruses" was submitted by “Bundesverband der Deutschen Industrie e.V. (BDI)” and “Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V.”.

German President Frank-Walter Steinmeier will award the 22st Deutscher Zukunftspreis for the year 2018 to one of the three nominated teams on November 28, 2018.

Resume

Prof. Dr. rer. nat. Helga Rübsamen-Schaeff

Born in Münchberg, Upper Franconia, grew up in Dusseldorf
1967 – 1973
Study of Chemistry and PhD (Dr. rer. nat.), University of Münster
1973 – 1979
Postdoctoral Fellow at the Universities of Cornell Ithaca, NY, USA and Gießen (research in biochemistry and virology). Start of own research group at the University of Cologne
1982 – 1987
Head of the Department of Immunotherapy at the Chemotherapeutical Research Insitute, Georg-Speyer-Haus, Frankfurt
1983
Habilitation, University of Frankfurt (venia legendi for Biochemistry)
1983 and 1985
Sabbatical at Harvard University, Cambridge, MA, USA (Molecular cloning of a human tumor virus, HTLV 1)
1987 – 1993
Scientific and Managing Director of the Chemotherapeutical Research Institute, Georg-Speyer-Haus, Frankfurt (Research on development of tumor cells (oncogenes) and HIV/ AIDS)
since 1998
Professor for Biochemistry at the University of Frankfurt
1994 – 2000
Vice President, worldwide Head of Antiviral Research, Bayer AG, continuation of professorship in Frankfurt
2001 – 2006
Senior Vice President, worldwide Head of Anti-Infectives Research Bayer Healthcare, continuation of professorship in Frankfurt
1.3.2006
Foundation of AiCuris GmbH & Co KG
2006 – 2015
CEO of the Biopharma Company AiCuris GmbH & Co. KG, Wuppertal
since 3/2015
Chair of the Advisory Board of AiCuris Anti-Infective Cures GmbH
December 2017
Market introduction of the first antiviral drug of AiCuris, PrevymisTM, in the US, followed by Germany and Japan in February and May 2018, respectively

Other activities

since 1972
Member of the German Chemical Society GdCh (1996-2003 in the Executive Board, 2000 and 2001: Vice President)
since 1976
Member of the Society for Virology
since 1990
Member of the German AIDS- Society
2001 – 2007
Member of the European Research Advisory Board, EURAB
2002 – 2011
Member in the Jury of „Deutscher Zukunftspreis“: Price by the President of State for Technology and Innovation
2003
Chair of the EU-Expert Commission: "Women in Industrial Research“
since 2003
Member in the Competence-Network Stem Cell Research in NRW
2003 – 2009
Member in the Senate of the Fraunhofer Society
2003 – 2013
Member of the University Council of the University of Vienna (Deputy Chair)
2006 – 2009
Member of the „ Research Union“ of the German Ministery for Research and Education
since 2014
Member in the Scientific Panel of Health of the EU Commission
since 2014
Member in the Board of Partners and Supervisory Board of E. Merck KG and Merck KGaA, respectively, Chair of the Research Committee of E. Merck KG
since 2015
Member in the Supervisory Board of 4SC
since 2015
Member in the Supervisory Board of the University Clinics of Bonn

Honors & Awards

Price of the University of Münster (for PhD thesis)
Stipend by Max Kade Foundation for postdoctoral Research at Cornell University
Winnacker Stipend
German Federal Cross of Merit, Class I
Mestemacher Price: Manager of the Year 2004
For AiCuris: Deloitte Allicence Breakthrough Alliance Award 2013
For AiCuris: Step Award 2013 by FAZ
IUPAC: Distinguished Woman in Chemistry or Chemical Engineering Award in 2015
German Chemical Society: Honorary Membership 2017
Member of the German National Academy of Sciences, Leopoldina, 2018

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Dr. rer. nat. Holger Zimmermann

Dec. 4,1968
Born in Gummersbach, NRW, Germany
1976 – 1980
Primary school in Gummersbach-Bernberg
1980 – 1988
Grammar school, Gymnasium Moltkestraße in Gummersbach
1988 – 1989
Military service, Fallschirmjägerbataillon Iserlohn
1989 – 1994
Study of Biology at the University of Cologne,
Diploma thesis at the Institute of Virology (Head: Prof. H.J. Eggers): Characterisation of a Rhodanine-resistant Echovirus 12 strain
1994 – 1996
PhD thesis at the Institute of Virology, University of Cologne
Awardee of the Deutschen Vereinigung zur Bekämpfung der Viruskrankheiten e.V.
Thesis: Molecular characterisation of Echovirus 9 variants
1997 – 2000
Post-doctoral fellow at the Institute for Molecular and Cell Biology / National University of Singapore
Research Project: Interactions of the viral oncoprotein E6 of high-risk papillomaviruses
1999
Thames Business School Singapore (Advanced Diploma in Business Administration)
Laboratory Head Virology, BayerHealthCare AG, Co-Inventor of Letermovir
Strategic Project Leader for Cytomegalovirus, BayerHealthCare AG
2000 – 2006
Head of Virology, AiCuris Anti-infective Cures GmbH
2003 – 2006
Chief Scientific Officer, AiCuris Anti-infective Cures GmbH
2006 – 2008
Member of the executive board, AiCuris Anti-infective Cures GmbH
2009 – 2015
Chief Executive Officer, AiCuris Anti-infective Cures GmbH
since 2013
Study of Biology at the University of Cologne,
Diploma thesis at the Institute of Virology (Head: Prof. H.J. Eggers): Characterisation of a Rhodanine-resistant Echovirus 12 strain
since 2015
PhD thesis at the Institute of Virology, University of Cologne
Awardee of the Deutschen Vereinigung zur Bekämpfung der Viruskrankheiten e.V.
Thesis: Molecular characterisation of Echovirus 9 variants

Other activities

Member of the Membership Committee of the International Society for Antiviral Research
Member of the committee Antivirale Therapie der Deutschen Vereinigung zur Bekämpfung der Viruskrankheiten e.V. and Gesellschaft für Virologie e.V.br />
Member of the board of BioDeutschland e.V.

 

Publications and Patents

Named inventor in more than 25 patent applications

Honors & Awards

For AiCuris: Deloitte Allicence Breakthrough Alliance Award 2013
For AiCuris: Step Award 2013 by FAZ

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Contact

Spokesperson

Prof. Dr. Helga Rübsamen-Schaeff
AiCuris Anti-infective Cures GmbH
Friedrich-Ebert-Str. 475 / Geb. 302
42117 Wuppertal
Phone: +49 (0) 202 / 31 76 31 176
E-Mail: helga.ruebsamen-schaeff@science-life.de

Press

Katja Woestenhemke
AiCuris Anti-infective Cures GmbHv Friedrich-Ebert-Str. 475 / Geb. 302
42117 Wuppertal
Phone: +49 (0) 202 / 31 76 31 176
Fax: +49 (0) 202 / 31 76 31 177
Mobile: +49 (0) 170 / 45 43 938
E-Mail: katja.woestenhemke@aicuris.com
www.aicuris.com

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