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Nominee 2021

mRNA vaccines for humanity

mRNA vaccines for humanity – the first COVID-19 vaccine ushers in a new era in medicine

Prof. Dr. med. Uğur Şahin (Spokesperson) /
PD Dr. med. Özlem Türeci
Prof. Dr. med. Christoph Huber
Prof. Katalin Karikó, Ph.D.
BioNTech SE, Mainz

(f.l.t.r.) Prof. Dr. med. Uğur Şahin, PD Dr. med. Özlem Türeci,
Prof. Dr. med. Christoph Huber

Since the beginning of 2020, COVID-19 has kept the world in suspense. The disease caused by the novel coronavirus has in the meantime claimed the lives of more than 4.5 million people worldwide. Many of those affected continue to suffer from long-term health issues even months after their recovery. For a long time there was neither an effective drug nor a vaccine to fight the disease which quickly grew into a pandemic. It normally takes years to develop and test vaccines. A decisive question in the fight against COVID-19 was: is there a way to obtain an effective vaccine faster?

Prof. Dr. Uğur Şahin, Dr. Özlem Türeci and Prof. Dr. Christoph Huber as well as Prof. Dr. Katalin Karikó. have for several decades been working on the mRNA technology on which the COVID-19 vaccine from Pfizer/BioNTech is based. The nominees were the first to develop and get approval for a vaccine to prevent COVID-19 - in an unprecedented short period of time. They based the vaccine on the novel mRNA technology. This biomolecule, a ribonucleic acid, converts genetic information into proteins in cells, a process in medical speak known as encoding.

In developing a COVID-19 vaccine based on this technology, the team utilized their vast knowledge and decades of experience from their research into immunotherapies - specifically in the fight against cancer - based on mRNA. Uğur Şahin is Chief Executive Officer of BioNTech, Özlem Türeci is Chief Medical Officer. Christoph Huber is scientific advisor and a member of the Supervisory Board. He founded BioNTech in 2008 together with Uğur Şahin and Özlem Türeci. Katalin Karikó has worked for BioNTech since 2013 and has served as Senior Vice President since 2019.

In the late 1980's, Katalin Karikó recognized that diseases can be individually and specifically treated with artificially produced messenger RNA. She succeeded in changing a building block of synthetic RNA in such a way that the biomolecule can be used in medical applications. Working together, Uğur Şahin and Özlem Türeci adopted this approach and continued to develop the mRNA technology further - supported by oncologist and immunologist Christoph Huber who until 2009 was Director of the Medical Clinic at the Johannes-Gutenberg University Medical Center in Mainz. The BioNTech company was founded by Uğur Şahin , Özlem Türeci and Christoph Huber on the vision of establishing a new kind of therapeutic that relies on the body's own defenses and has the potential to use the human immune system to cure diseases.

The mRNA technology can also be used to develop vaccines. In the process, the mRNA delivers the necessary genetic information to cells in muscle tissue to produce antigens. In this way, the cells produce proteins following the building plan delivered by the messenger RNA which triggers a response of the immune system: the foundation of an immunization.

As the first signs of an imminent pandemic due COVID-19 appeared in early 2020, founders Uğur Şahin and Özlem Türeci used BioNTech's proprietary mRNA technology to fight the spread of the new disease. Based on their decades of research and development, they set themselves the proverbial goal with "Project Lightspeed" to develop a safe and effective COVID-19 vaccine at a record pace. To do so, they initially created a series of potential effective biomolecules and from them identified four of the most promising vaccine candidates. Together with pharmaceutical groups Pfizer in the USA and Fosun Pharma of China, the team at BioNTech started a series of clinical studies in several countries, including Germany, with these four substances in which a total of around 44,000 people participated.

This particularly efficient parallel approach led to the desired result in less than a year - much faster than the development of any other vaccine previously. The results of the studies demonstrate a 95 percent protection against infection with the virus for the best of the tested drug candidates. The vaccine which is known by its product name COMIRNATY® received emergency approval in Great Britain at the beginning of December 2020, followed by emergency approval in numerous other countries. It was the world's first approved vaccine against COVID-19 with a completed Phase 3 study and at the same time the first based on the mRNA technology. In the meantime, it has been proven that it is not only effective against the original SARS-CoV-2 variant, but to date also against all known newly occurring variants. If it should be necessary, the mRNA technology will allow the vaccine to be modified rapidly for virus mutations which are not covered by the current vaccine. It is also suitable for use in revaccination campaigns.

Around three billion doses of the COVID-19 vaccine will have shipped by the end of 2021. This also includes large quantities of the vaccine destined for low-income countries at cost. To best meet the global demand for the vaccine, the company from Mainz built up large production capacity very early on, including the takeover of a production facility in Marburg, Germany, where around 1 billion vaccine doses can be produced per year. BioNTech also worked very early with its partners to set up a global distribution network to be able to make the vaccine as fast as possible to as many people as possible.

Following the successful use of the technology in the fighting of the COVID-19 pandemic, Uğur Şahin and Özlem Türeci have from the beginning continued to pursue their declared objective to use the mRNA technology to develop innovative drugs and vaccines to fight a number of diseases. They have already made great progress in the area of cancer therapy. The team at BioNTech also has several novel immunotherapies in the clinical test phase. Over the next few years, the scientists who refer to themselves as "immune engineers" hope to take the first therapies to market maturity. Numerous patents based on the mRNA technology have been applied for or already granted. They are also working on developing immunotherapy drugs and vaccines to treat diseases such as HIV, tuberculosis, various inflammatory diseases and autoimmune diseases such as multiple sclerosis. The nominated teams hope that even allergies could be cured in future using drugs developed on the basis of the mRNA technology.

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Prof. Dr. Uğur Şahin

1984 – 1990
Medical School, University of Cologne
1987 – 1990
Doctoral Thesis, Department of Internal Medicine, University of Cologne
1990 – 1991
Internship, Department of Internal Medicine, University Cologne
1992
PhD (Summa cum laude), University of Cologne
1992 – 1999
Resident, Department of Internal Medicine, University Hospital of the Saarland (Homburg)
1999
Post-doctoral Lecturer Qualification (“Habilitation”), Molecular Medicine & Immunology at the University of Homburg/Saar
2000 – 2001
Visiting Scientist, Research group of Prof. Hans Hengartner and Prof. Rolf Zinkernagel, ETH and University Hospital, Zurich, Switzerland
2001 – 2016
Co-founder and Chairman of the Clinical Advisory Board, Ganymed Pharmaceuticals GmbH (is now an Astellas Pharma subsidiary)
2001 – 2008
Junior Research Group Leader, University Medical Center, Johannes Gutenberg University (Mainz)
Since 2001
Graduate Student Advisor, University Medical Center, Johannes Gutenberg University, Germany
2006 – 2013
Associate Professor (W2), Experimental & Translational Oncology, University Medical Center, Johannes Gutenberg University (Mainz)
Since 2009
Co-founder and CEO, BioNTech
2010 – 2019
Co-founder and Scientific Director, TRON – Translational Oncology at the University Medical Centre of the Johannes Gutenberg University gGmbH (Mainz)
Since 2013
Full Professor (W3), Translational Oncology & Immunology, University Medical Center, Johannes Gutenberg University (Mainz)
Since 2018
Chairman, Scientific Management Board, Helmholtz Institute for Translational Oncology (Mainz)

Other Activity and Honorary Posts

Since 1992
Referee, Nature, Science, Cell, Nature Medicine, Nature Biotechnology, Science Transl. Medicine, Nature Communications, Cancer Immunology Research, among others
Since 2001
Supervision of graduate students and postdoctoral fellows at the University Medical Center of Johannes Gutenberg University (Mainz)
Since 2004
Memberships of scientific societies, including American Society of Clinical Oncology, American Association for Cancer Research, Co-founder of CI3 Cluster of Individualized Immunointervention, Association for Cancer Immunotherapy, German Society for Immunology
Since 2005
Lecturer, Faculty of Medicine, Johannes Gutenberg University (Mainz)
Since 2013
Editorial Board Member, Cancer Immunology Research, American Association for Cancer Research
Since 2014
Organization of scientific meetings, including International “mRNA Health Conference” and “Keystone Symposium on Lymphocytes and their Roles in Cancer”

Patents

 
Dr. Ugur Sahin is co-Inventor in more than 500 filed patents applications and patents.

Publications

 
Liu Y, Liu J, Xia H, Zhang X, Zou J, Fontes-Garfias CR, Weaver SC, Swanson KA, Cai H, Sarkar R, Chen W, Cutler M, Cooper D, Muik A, Sahin U, Jansen KU, Xie X, Dormitzer PR, Shi PY. BNT162b2-Elicited Neutralization against New SARS-CoV-2 Spike Variants. N Engl J Med. 2021 Jul 29;385(5):472-474. doi: 10.1056/NEJMc2106083. Epub 2021 May 12.
Sahin, U., Muik, A., Vogler, I., Derhovanessian, E., Kranz, L. M., Vormehr, M., …., , Cooper, D., Kyratsous, C. A., Dormitzer, P. R., Jansen, K. U. & Türeci, Ö. BNT162b2 induces SARS-CoV-2-neutralising antibodies and T cells in humans. Nature (2021).
Krienke, C., Kolb, L., Diken, E., Streuber, M., Kirchhoff, S., Bukur, T., Akilli-Öztürk, Ö., Kranz, L. M., Berger, H., Petschenka, J., Diken, M., Kreiter, S., Yogev, N., Waisman, A., Karikó, K., Türeci, Ö. & Sahin, U. A noninflammatory mRNA vaccine for treatment of experimental autoimmune encephalomyelitis. Science 371, 145–153 (2021).
Vogel A, Kanevsky I, Che Y, Swanson KA, Muik A , Vormehr M , Kranz LM , Walzer K , Hein S, Güler A , Loschko J, Maddur M , Setlik A , Tompkins K , Cole J, .., Türeci Ö, Dormitzer PR, Jansen K , Sahin U. BNT162b vaccines protect non-human primates against SARS-CoV-2. Nature 2021.
Walsh, E. E., Frenck, R. W. J., Falsey, A. R., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Mulligan, M. J., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P.-Y., Türeci, Ö., Tompkins, K. R., Lyke, K. E., Raabe, V., Dormitzer, P. R., Jansen, K. U., Şahin, U. & Gruber, W. C. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. N. Engl. J. Med. (2020) doi:10.1056/NEJMoa2027906.
Beissert, T., Perkovic, M., Vogel, A., Erbar, S., Walzer, K. C., Hempel, T., Brill, S., Haefner, E., Becker, R., Türeci, Ö. & Sahin, U. A Trans-amplifying RNA Vaccine Strategy for Induction of Potent Protective Immunity. Mol. Ther. 28, 119–128 (2020).
Mulligan, M. J., Lyke, K. E., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Raabe, V., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P.-Y., Türeci, Ö., Tompkins, K. R., Walsh, E. E., Frenck, R., Falsey, A. R., Dormitzer, P. R., Gruber, W. C., Şahin, U. & Jansen, K. U. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature 586, 589–593 (2020).
Sahin, U., Muik, A., Derhovanessian, E., Vogler, I., Kranz, L. M., Vormehr, M., Baum, A., Pascal, K., Quandt, J., Maurus, D., Brachtendorf, S., Lörks, V., Sikorski, J., Hilker, R., Becker, D., Eller, A.-K., Grützner, J., Boesler, C., Rosenbaum, C., Kühnle, M.-C., Luxemburger, U., Kemmer-Brück, A., Langer, D., Bexon, M., Bolte, S., Karikó, K., Palanche, T., Fischer, B., Schultz, A., Shi, P.-Y., Fontes-Garfias, C., Perez, J. L., Swanson, K. A., Loschko, J., Scully, I. L., Cutler, M., Kalina, W., Kyratsous, C. A., Cooper, D., Dormitzer, P. R., Jansen, K. U. & Türeci, Ö. COVID-19 vaccine BNT162b1 elicits human antibody and T(H)1 T cell responses. Nature 586, 594–599 (2020).
Reinhard, K., Rengstl, B., Oehm, P., Michel, K., Billmeier, A., Hayduk, N., Klein, O., Kuna, K., Ouchan, Y., Wöll, S., Christ, E., Weber, D., Suchan, M., Bukur, T., Birtel, M., Jahndel, V., Mroz, K., Hobohm, K., Kranz, L., Diken, M., Kühlcke, K., Türeci, Ö. & Sahin, U. An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors. Science 367, 446–453 (2020).
Sahin, U., Oehm, P., Derhovanessian, E., Jabulowsky, R. A., Vormehr, M., Gold, M., Maurus, D., Schwarck-Kokarakis, D., Kuhn, A. N., Omokoko, T., Kranz, L. M., Diken, M., Kreiter, S., Haas, H., Attig, S., Rae, R., Cuk, K., Kemmer-Brück, A., Breitkreuz, A., Tolliver, C., Caspar, J., Quinkhardt, J., Hebich, L., Stein, M., Hohberger, A., Vogler, I., Liebig, I., Renken, S., Sikorski, J., Leierer, M., Müller, V., Mitzel-Rink, H., Miederer, M., Huber, C., Grabbe, S., Utikal, J., Pinter, A., Kaufmann, R., Hassel, J. C., Loquai, C. & Türeci, Ö. An RNA vaccine drives immunity in checkpoint-inhibitor-treated melanoma. Nature 585, 107–112 (2020).
Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Moreira, E. D., Zerbini, C., Bailey, R., Swanson, K. A., Roychoudhury, S., Koury, K., Li, P., Kalina, W. V, Cooper, D., Frenck, R. W. J., Hammitt, L. L., Türeci, Ö., Nell, H., Schaefer, A., Ünal, S., Tresnan, D. B., Mather, S., Dormitzer, P. R., Şahin, U., Jansen, K. U. & Gruber, W. C. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N. Engl. J. Med. 383, 2603–2615 (2020).
Orlandini von Niessen, A. G., Poleganov, M. A., Rechner, C., Plaschke, A., Kranz, L. M., Fesser, S., Diken, M., Löwer, M., Vallazza, B., Beissert, T., Bukur, V., Kuhn, A. N., Türeci, Ö. & Sahin, U. Improving mRNA-Based Therapeutic Gene Delivery by Expression-Augmenting 3’ UTRs Identified by Cellular Library Screening. Mol. Ther. 27, 824–836 (2019).
Sahin, U. & Türeci, Ö. Personalized vaccines for cancer immunotherapy. Science 359, 1355–1360 (2018).
Sahin, U., Derhovanessian, E., Miller, M., Kloke, B.-P., Simon, P., Löwer, M., Bukur, V., Tadmor, A. D., Luxemburger, U., Schrörs, B., Omokoko, T., Vormehr, M., Albrecht, C., Paruzynski, A., Kuhn, A. N., Buck, J., Heesch, S., Schreeb, K. H., Müller, F., Ortseifer, I., Vogler, I., Godehardt, E., Attig, S., Rae, R., Breitkreuz, A., Tolliver, C., Suchan, M., Martic, G., Hohberger, A., Sorn, P., Diekmann, J., Ciesla, J., Waksmann, O., Brück, A.-K., Witt, M., Zillgen, M., Rothermel, A., Kasemann, B., Langer, D., Bolte, S., Diken, M., Kreiter, S., Nemecek, R., Gebhardt, C., Grabbe, S., Höller, C., Utikal, J., Huber, C., Loquai, C. & Türeci, Ö. Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer. Nature 547, 222–226 (2017).
Kranz, L. M., Diken, M., Haas, H., Kreiter, S., Loquai, C., Reuter, K. C., Meng, M., Fritz, D., Vascotto, F., Hefesha, H., Grunwitz, C., Vormehr, M., Hüsemann, Y., Selmi, A., Kuhn, A. N., Buck, J., Derhovanessian, E., Rae, R., Attig, S., Diekmann, J., Jabulowsky, R. A., Heesch, S., Hassel, J., Langguth, P., Grabbe, S., Huber, C., Türeci, Ö. & Sahin, U. Systemic RNA delivery to dendritic cells exploits antiviral defence for cancer immunotherapy. Nature 534, 396–401 (2016).
Kreiter, S., Vormehr, M., van de Roemer, N., Diken, M., Löwer, M., Diekmann, J., Boegel, S., Schrörs, B., Vascotto, F., Castle, J. C., Tadmor, A. D., Schoenberger, S. P., Huber, C., Türeci, Ö. & Sahin, U. Mutant MHC class II epitopes drive therapeutic immune responses to cancer. Nature 520, 692–696 (2015).
Sahin, U., Karikó, K. & Türeci, Ö. mRNA-based therapeutics--developing a new class of drugs. Nat. Rev. Drug Discov. 13, 759–780 (2014).
Kreiter, S., Diken, M., Selmi, A., Diekmann, J., Attig, S., Hüsemann, Y., Koslowski, M., Huber, C., Türeci, Ö. & Sahin, U. FLT3 ligand enhances the cancer therapeutic potency of naked RNA vaccines. Cancer Res. 71, 6132–6142 (2011).
Türeci, O., Koslowski, M., Helftenbein, G., Castle, J., Rohde, C., Dhaene, K., Seitz, G. & Sahin, U. Claudin-18 gene structure, regulation, and expression is evolutionary conserved in mammals. Gene 481, 83–92 (2011).
Diken, M., Kreiter, S., Selmi, A., Britten, C. M., Huber, C., Türeci, Ö. & Sahin, U. Selective uptake of naked vaccine RNA by dendritic cells is driven by macropinocytosis and abrogated upon DC maturation. Gene Ther. 18, 702–708 (2011).
Koslowski, M., Luxemburger, U., Türeci, O. & Sahin, U. Tumor-associated CpG demethylation augments hypoxia-induced effects by positive autoregulation of HIF-1α. Oncogene 30, 876–882 (2011).
Kuhn, A. N., Diken, M., Kreiter, S., Selmi, A., Kowalska, J., Jemielity, J., Darzynkiewicz, E., Huber, C., Türeci, O. & Sahin, U. Phosphorothioate cap analogs increase stability and translational efficiency of RNA vaccines in immature dendritic cells and induce superior immune responses in vivo. Gene Ther. 17, 961–971 (2010).
Kreiter, S., Selmi, A., Diken, M., Koslowski, M., Britten, C. M., Huber, C., Türeci, O. & Sahin, U. Intranodal vaccination with naked antigen-encoding RNA elicits potent prophylactic and therapeutic antitumoral immunity. Cancer Res. 70, 9031–9040 (2010).
Holtkamp, S., Kreiter, S., Selmi, A., Simon, P., Koslowski, M., Huber, C., Türeci, O. & Sahin, U. Modification of antigen-encoding RNA increases stability, translational efficacy, and T-cell stimulatory capacity of dendritic cells. Blood 108, 4009–4017 (2006).
Sahin, U., Türeci, O., Schmitt, H., Cochlovius, B., Johannes, T., Schmits, R., Stenner, F., Luo, G., Schobert, I. & Pfreundschuh, M. Human neoplasms elicit multiple specific immune responses in the autologous host. Proc. Natl. Acad. Sci. U. S. A. 92, 11810–11813 (1995).

Honors and Awards (Selection)

2012
German Federal Ministry of Education and Research Peak Cluster (BMBF Spitzencluster) Award – member of CI3 Cluster for Individualized Immune Intervention
2018
ERC Advanced Grant “SUMMIT” Improving Individualized Cancer Vaccines
2019
Mustafa Prize
2019
German Cancer Award
2021
Axel Springer Award
2021
Federal Cross of Merit
2021
Hall of Fame German Science
2021
Empress Theophano Prize
2021
Precision Medicine World Conference (PMWC) Luminary Award
2021
Election as a Member of European Molecular Biology Organization (EMBO)
2021
Princess of Asturias Award in the category “Scientific Research”

Dr. Özlem Türeci

1986 – 1992
Medical studies, Saarland University Faculty of Medicine (Homburg)
1989 – 1991
Doctoral thesis, Institute of Human Genetics, Saarland University Faculty of Medicine (Homburg)
1992 – 1994
Junior residency, 1st Department of Internal Medicine, Saarland University Medical Center (Homburg)
1993 – 1996
Postdoctoral research, Saarland University Medical Center (Homburg)
1996 – 2000
Research Group Leader, Saarland University Medical Center (Homburg)
2000 – 2010
Research Group Leader, University Medical Center, Johannes Gutenberg University (Mainz)
2001 – 2004
Scientific Technical Manager, European Cancer Immunome Program (EUCIP)
2001 - 2016
Co-founder and CSO (2001 – 2008), CEO/CMO (2008 – 2016), Ganymed Pharmaceuticals AG (since 2016 an Astellas Pharma subsidiary)
2002
Habilitation in “Molecular Medicine”, University Medical Center, Johannes Gutenberg University (Mainz)
Since 2002
Associate Professor/Lecturer (“Privatdozent”), University Medical Center, Johannes Gutenberg University (Mainz)
2003 – 2008
Head of High-Density-Microarray Core Facility, University Medical Center, Johannes Gutenberg University (Mainz)
2009 – 2018
Co-founder and Chair (Clinical and Scientific Advisory Board), BioNTech SE
Since 2011
Co-founder and Chair, Cluster of Individualized Immune Intervention Ci3 (Mainz)
2013 – 2016
Postgraduate MSc studies, Regulatory Affairs for Biopharmaceutical Products program, EUCRAF/University of Strasbourg
Since 2018
Co-Founder and Chief Medical Officer, BioNTech SE
Since 2019
President, Association for Cancer Immunotherapy CIMT, Mainz

Other Activity and Honorary Posts

1992 – 2001
Various lectures and seminars on immunology and biotechnology, Saarland University Faculty of Medicine (Homburg)
2004 – 2012
Various lectures and seminars at the University Medical Center, Johannes Gutenberg University (Mainz)
Member in various scientific societies (incl. American Society of Clinical Oncology, American Association for Cancer Research, Association for Cancer Immunotherapy, Cluster of Individualized Immune Intervention, German Society for Immunology)
Commissions of trust/reviewer for various organizations (e.g. German Cancer Aid, Federal Ministry of Education and Research) and Journals (e.g. Journal of Immunology, Science)

Patents

 
Dr. Özlem Türeci is co-Inventor in more than 500 filed international patent applications and patents.

Publikationen

 
Sahin, U., Muik, A., Vogler, I., Derhovanessian, E., Kranz, L. M., Vormehr, M., …., , Cooper, D., Kyratsous, C. A., Dormitzer, P. R., Jansen, K. U. & Türeci, Ö. BNT162b2 induces SARS-CoV-2-neutralising antibodies and T cells in humans. Nature (2021).
Krienke, C., Kolb, L., Diken, E., Streuber, M., Kirchhoff, S., Bukur, T., Akilli-Öztürk, Ö., Kranz, L. M., Berger, H., Petschenka, J., Diken, M., Kreiter, S., Yogev, N., Waisman, A., Karikó, K., Türeci, Ö. & Sahin, U. A noninflammatory mRNA vaccine for treatment of experimental autoimmune encephalomyelitis. Science 371, 145–153 (2021).
Vogel A, Kanevsky I, Che Y, Swanson KA, Muik A , Vormehr M , Kranz LM , Walzer K , Hein S, Güler A , Loschko J, Maddur M , Setlik A , Tompkins K , Cole J, .., Türeci Ö, Dormitzer PR, Jansen K , Sahin U. BNT162b vaccines protect non-human primates against SARS-CoV-2. Nature 2021.
Alexander Muik, Ann-Kathrin Wallisch, Bianca Sänger, Kena A. Swanson, Julia Mühl, Wei Chen, Hui Cai, Ritu Sarkar, Özlem Türeci, Philip R. Dormitzer, U. S. Neutralization of SARS-CoV-2 lineage B.1.1.7 pseudovirus by BNT162b2 vaccine-elicited human sera. Science (2021).
Walsh, E. E., Frenck, R. W. J., Falsey, A. R., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Mulligan, M. J., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P.-Y., Türeci, Ö., Tompkins, K. R., Lyke, K. E., Raabe, V., Dormitzer, P. R., Jansen, K. U., Şahin, U. & Gruber, W. C. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. N. Engl. J. Med. (2020) doi:10.1056/NEJMoa2027906.
Beissert, T., Perkovic, M., Vogel, A., Erbar, S., Walzer, K. C., Hempel, T., Brill, S., Haefner, E., Becker, R., Türeci, Ö. & Sahin, U. A Trans-amplifying RNA Vaccine Strategy for Induction of Potent Protective Immunity. Mol. Ther. 28, 119–128 (2020).
Mulligan, M. J., Lyke, K. E., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Raabe, V., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P.-Y., Türeci, Ö., Tompkins, K. R., Walsh, E. E., Frenck, R., Falsey, A. R., Dormitzer, P. R., Gruber, W. C., Şahin, U. & Jansen, K. U. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature 586, 589–593 (2020).
Sahin, U., Muik, A., Derhovanessian, E., Vogler, I., Kranz, L. M., Vormehr, M., Baum, A., Pascal, K., Quandt, J., Maurus, D., Brachtendorf, S., Lörks, V., Sikorski, J., Hilker, R., Becker, D., Eller, A.-K., Grützner, J., Boesler, C., Rosenbaum, C., Kühnle, M.-C., Luxemburger, U., Kemmer-Brück, A., Langer, D., Bexon, M., Bolte, S., Karikó, K., Palanche, T., Fischer, B., Schultz, A., Shi, P.-Y., Fontes-Garfias, C., Perez, J. L., Swanson, K. A., Loschko, J., Scully, I. L., Cutler, M., Kalina, W., Kyratsous, C. A., Cooper, D., Dormitzer, P. R., Jansen, K. U. & Türeci, Ö. COVID-19 vaccine BNT162b1 elicits human antibody and T(H)1 T cell responses. Nature 586, 594–599 (2020).
Reinhard, K., Rengstl, B., Oehm, P., Michel, K., Billmeier, A., Hayduk, N., Klein, O., Kuna, K., Ouchan, Y., Wöll, S., Christ, E., Weber, D., Suchan, M., Bukur, T., Birtel, M., Jahndel, V., Mroz, K., Hobohm, K., Kranz, L., Diken, M., Kühlcke, K., Türeci, Ö. & Sahin, U. An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors. Science 367, 446–453 (2020).
Sahin, U., Oehm, P., Derhovanessian, E., Jabulowsky, R. A., Vormehr, M., Gold, M., Maurus, D., Schwarck-Kokarakis, D., Kuhn, A. N., Omokoko, T., Kranz, L. M., Diken, M., Kreiter, S., Haas, H., Attig, S., Rae, R., Cuk, K., Kemmer-Brück, A., Breitkreuz, A., Tolliver, C., Caspar, J., Quinkhardt, J., Hebich, L., Stein, M., Hohberger, A., Vogler, I., Liebig, I., Renken, S., Sikorski, J., Leierer, M., Müller, V., Mitzel-Rink, H., Miederer, M., Huber, C., Grabbe, S., Utikal, J., Pinter, A., Kaufmann, R., Hassel, J. C., Loquai, C. & Türeci, Ö. An RNA vaccine drives immunity in checkpoint-inhibitor-treated melanoma. Nature 585, 107–112 (2020).
Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Moreira, E. D., Zerbini, C., Bailey, R., Swanson, K. A., Roychoudhury, S., Koury, K., Li, P., Kalina, W. V, Cooper, D., Frenck, R. W. J., Hammitt, L. L., Türeci, Ö., Nell, H., Schaefer, A., Ünal, S., Tresnan, D. B., Mather, S., Dormitzer, P. R., Şahin, U., Jansen, K. U. & Gruber, W. C. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N. Engl. J. Med. 383, 2603–2615 (2020).
Orlandini von Niessen, A. G., Poleganov, M. A., Rechner, C., Plaschke, A., Kranz, L. M., Fesser, S., Diken, M., Löwer, M., Vallazza, B., Beissert, T., Bukur, V., Kuhn, A. N., Türeci, Ö. & Sahin, U. Improving mRNA-Based Therapeutic Gene Delivery by Expression-Augmenting 3’ UTRs Identified by Cellular Library Screening. Mol. Ther. 27, 824–836 (2019).
Sahin, U. & Türeci, Ö. Personalized vaccines for cancer immunotherapy. Science 359, 1355–1360 (2018).
Sahin, U., Derhovanessian, E., Miller, M., Kloke, B.-P., Simon, P., Löwer, M., Bukur, V., Tadmor, A. D., Luxemburger, U., Schrörs, B., Omokoko, T., Vormehr, M., Albrecht, C., Paruzynski, A., Kuhn, A. N., Buck, J., Heesch, S., Schreeb, K. H., Müller, F., Ortseifer, I., Vogler, I., Godehardt, E., Attig, S., Rae, R., Breitkreuz, A., Tolliver, C., Suchan, M., Martic, G., Hohberger, A., Sorn, P., Diekmann, J., Ciesla, J., Waksmann, O., Brück, A.-K., Witt, M., Zillgen, M., Rothermel, A., Kasemann, B., Langer, D., Bolte, S., Diken, M., Kreiter, S., Nemecek, R., Gebhardt, C., Grabbe, S., Höller, C., Utikal, J., Huber, C., Loquai, C. & Türeci, Ö. Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer. Nature 547, 222–226 (2017).
Kranz, L. M., Diken, M., Haas, H., Kreiter, S., Loquai, C., Reuter, K. C., Meng, M., Fritz, D., Vascotto, F., Hefesha, H., Grunwitz, C., Vormehr, M., Hüsemann, Y., Selmi, A., Kuhn, A. N., Buck, J., Derhovanessian, E., Rae, R., Attig, S., Diekmann, J., Jabulowsky, R. A., Heesch, S., Hassel, J., Langguth, P., Grabbe, S., Huber, C., Türeci, Ö. & Sahin, U. Systemic RNA delivery to dendritic cells exploits antiviral defence for cancer immunotherapy. Nature 534, 396–401 (2016).
Kreiter, S., Vormehr, M., van de Roemer, N., Diken, M., Löwer, M., Diekmann, J., Boegel, S., Schrörs, B., Vascotto, F., Castle, J. C., Tadmor, A. D., Schoenberger, S. P., Huber, C., Türeci, Ö. & Sahin, U. Mutant MHC class II epitopes drive therapeutic immune responses to cancer. Nature 520, 692–696 (2015).
Sahin, U., Karikó, K. & Türeci, Ö. mRNA-based therapeutics--developing a new class of drugs. Nat. Rev. Drug Discov. 13, 759–780 (2014).
Kreiter, S., Diken, M., Selmi, A., Diekmann, J., Attig, S., Hüsemann, Y., Koslowski, M., Huber, C., Türeci, Ö. & Sahin, U. FLT3 ligand enhances the cancer therapeutic potency of naked RNA vaccines. Cancer Res. 71, 6132–6142 (2011).
Türeci, O., Koslowski, M., Helftenbein, G., Castle, J., Rohde, C., Dhaene, K., Seitz, G. & Sahin, U. Claudin-18 gene structure, regulation, and expression is evolutionary conserved in mammals. Gene 481, 83–92 (2011).
Diken, M., Kreiter, S., Selmi, A., Britten, C. M., Huber, C., Türeci, Ö. & Sahin, U. Selective uptake of naked vaccine RNA by dendritic cells is driven by  macropinocytosis and abrogated upon DC maturation. Gene Ther. 18, 702–708 (2011).
Koslowski, M., Luxemburger, U., Türeci, O. & Sahin, U. Tumor-associated CpG demethylation augments hypoxia-induced effects by positive  autoregulation of HIF-1α. Oncogene 30, 876–882 (2011).
Kuhn, A. N., Diken, M., Kreiter, S., Selmi, A., Kowalska, J., Jemielity, J., Darzynkiewicz, E., Huber, C., Türeci, O. & Sahin, U. Phosphorothioate cap analogs increase stability and translational efficiency of RNA vaccines in immature dendritic cells and induce superior immune responses in vivo. Gene Ther. 17, 961–971 (2010).
Kreiter, S., Selmi, A., Diken, M., Koslowski, M., Britten, C. M., Huber, C., Türeci, O. & Sahin, U. Intranodal vaccination with naked antigen-encoding RNA elicits potent prophylactic and therapeutic antitumoral immunity. Cancer Res. 70, 9031–9040 (2010).
Holtkamp, S., Kreiter, S., Selmi, A., Simon, P., Koslowski, M., Huber, C., Türeci, O. & Sahin, U. Modification of antigen-encoding RNA increases stability, translational efficacy, and T-cell stimulatory capacity of dendritic cells. Blood 108, 4009–4017 (2006).
Sahin, U., Türeci, O., Schmitt, H., Cochlovius, B., Johannes, T., Schmits, R., Stenner, F., Luo, G., Schobert, I. & Pfreundschuh, M. Human neoplasms elicit multiple specific immune responses in the autologous host. Proc. Natl. Acad. Sci. U. S. A. 92, 11810–11813 (1995).

Lectures

 
Dr. Özlem Türeci has given more than 80 lectures at international and national scientific conferences and symposia (e.g. Science Asia, AACR, CICON, ESMO IO).

Honors and Awards (Selection)

2004
Heisenberg Scholarship, German Research Foundation (DFG)
2005
Georges Köhler Award, German Society for Immunology (DGFI)
2020
German Sustainability Award
2021
Axel Springer Award
2021
Federal Cross of Merit
2021
Hall of Fame German Science
2021
Empress Theophano Prize
2021
Precision Medicine World Conference Luminary Award
2021
Election as a Member of European Molecular Biology Organization (EMBO)
2021
Princess of Asturias Award in the category “Scientific Research”

Prof. Dr. med. Christoph Huber

1962 – 1968
Medical studies and PhD, University of Innsbruck, Austria
1968 – 1974
Specialist training for internal medicine, University of Innsbruck
1974 – 1975
Research stays, e.g. at the Wallenberg Laboratory, Uppsala University, Sweden
1976
Post-doctoral lecturer qualification (“Habilitation”) for internal medicine, focus on hematology-oncology and applied immunology, University of Innsbruck
1981
Training in clinical bone marrow transplantation, Hutchinson Cancer Research Center, Seattle, USA
1983
Founder and Head, Bone Marrow Transplantation Unit, University Hospital for Internal Medicine, Innsbruck
1986 – 2009
Professor of Clinical Immunobiology and Head of the Department, University of Innsbruck
1990 – 2009
Full Professor of Internal Medicine and Head of the Medical Clinic and Polyclinic III, University Medicine of the Johannes Gutenberg University, Mainz
2001 – 2016
Co-Founder, Supervisory Board and scientific advisor, Ganymed Pharmaceuticals AG, Mainz
Since 2008
Co-Founder, Supervisory Board and scientific advisor, BioNTech SE, Mainz
Since 2009
Co-founder and scientific advisor, TRON – Translational Oncology at the University Medical Center of the Johannes Gutenberg University Mainz; now advisor to the Management and Supervisory Board

Other Activities and Honorary Posts

1990 – 1998
Chairman of the Tumor Center Rhineland-Palatinate
1996 – 2008
Speaker of the Collaborative Research Center 432 “Mechanisms of Tumor Defense and their Therapeutic Influence”
1997 – 2008
Chairman of the Clinical Committee of the University Hospital Mainz
Since 1997
Member of the Austrian Academy of Sciences
2002 – 2019
Founding President, since 2019 board member of the Association for Cancer Immunotherapy (CIMT)
2005 – 2009
Chairman, Immunology Centre of Excellence Rhineland-Palatinate
2007 – 2011
Chairman, commission for somatic gene therapy of the German Medical Council
Since 2012
Chairman, Cluster of Individualized Immune Intervention Ci3 (Mainz)
Since 2019
Founding president, European Network Cancer Immunotherapy (ENCI)
Prominent roles on research funding bodies of the DFG, the EU, German Cancer Aid, Cancer Research UK, the Swiss National Science Foundation and other organizations.

Honors and Awards (Selection)

2004
Rhineland-Palatinate State Medal of Merit
2007
Honorary Doctor, Medical University of Innsbruck
2015
Honorary Medal of the Province of Tyrol
2015
Federal Cross of Merit of the Federal Republic of Germany
2020
Austrian Cross of Merit for Science and Art 1st Class
2021
Honorary Doctor of the University Medicine Mainz
2021
Honorary Member of the Austrian Academy of Sciences

Katalin Karikó, PhD

1973 – 1978
Study of Biology, University of Szeged (Hungary)
1978 - 1982
PhD in Biochemistry, University of Szeged (Hungary)
1982 – 1985
Postdoctoral fellow, Biological Research Center, Hungarian Academy of Sciences (Szeged, Hungary)
1985 – 1988
Postdoctoral fellow, Department of Biochemistry, Temple University (Philadelphia, USA)
1988 – 1989
Postdoctoral fellow, Department of Pathology, USUHS (Bethesda, USA)
1989 – 1995
Research Assistant Professor, Department of Medicine, University of Pennsylvania (Philadelphia, USA)
1995 – 2009
Senior Research Investigator, Department of Neurosurgery, University of Pennsylvania (Philadelphia, USA)
2006 – 2013
Founder and CEO of RNARx, a company established to develop nucleoside-modified mRNA for therapy
2009 – 2021
Adjunct Associate Professor, Department of Neurosurgery, University of Pennsylvania (Philadelphia, USA)
2013 – 2019
Vice President, BioNTech
Since 2019
Senior Vice President, BioNTech
Since 2021
Adjunct Professor, Department of Neurosurgery, University of Pennsylvania (Philadelphia, USA)

Other Activity and Honorary Posts (Selection)

Since 1992
Member of the AAAS (American Association for the Advancement of Science)
Since 2020
Elected member of Academia Europaea
Since 2013
Organization of scientific meetings, including International “mRNA Health Conference” and “Keystone Symposium on Progress in Vaccine Development for Infectious Diseases”
Since 2019
Guest editor for Molecular Therapy 2019 (special issue on mRNA Therapy), for MDPI 2021 (Special Issue on mRNA Therapeutics: A Themed Issue in Honor of Professor Katalin Karikó)

Patents

 
She is co-inventor in more 14 awarded international patents.

Publikationen

 
Selected from 92 publications as they are the most relevant for mRNA drug development
Karikó, K., Kuo, A., Barnathan, E. S., and Langer, D. J: Phosphate-enhanced transfection of cationic lipid-complexed mRNA and plasmid DNA. Biochimica et biophysica acta 1369, 320, 1998.
Karikó, K., Kuo, A., and Barnathan, E: Overexpression of urokinase receptor in mammalian cells following administration of the in vitro transcribed encoding mRNA. Gene Ther 6, 1092, 1999.
Weissman, D., Ni, H., Scales, D., Dude, A., Capodici, J., McGibney, K., Abdool, A., Isaacs, S. N., Cannon, G., and Karikó, K: HIV gag mRNA transfection of dendritic cells (DC) delivers encoded antigen to MHC class I and II molecules, causes DC maturation, and induces a potent human in vitro primary immune response. J Immunol 165, 4710, 2000.
Karikó, K., Ni, H., Capodici, J., Lamphier, M., and Weissman, D: mRNA is an endogenous ligand for Toll-like receptor 3. J Biol Chem 279, 12542, 2004.
Koski, G. K., Karikó, K., Xu, S., Weissman, D., Cohen, P. A., and Czerniecki, B. J: Cutting Edge: Innate immune system discriminates between RNA containing bacterial versus eukaryotic structural features that prime for high-level IL-12 secretion by dendritic cells. J Immunol 172, 3989, 2004.
Karikó, K., Buckstein, M., Ni, H., and Weissman, D: Suppression of RNA recognition by Toll-like receptors: the impact of nucleoside modification and the evolutionary origin of RNA. Immunity 23, 165, 2005.
Karikó, K., Muramatsu, H., Welsh, F. A., Ludwig, J., Kato, H., Akira, S., and Weissman, D: Incorporation of pseudouridine into mRNA yields superior nonimmunogenic vector with increased translational capacity and biological stability. Mol Ther 16, 1833, 2008.
Anderson, B. R., Muramatsu, H., Nallagatla, S. R., Bevilacqua, P. C., Sansing, L. H., Weissman, D., and Karikó, K: Incorporation of pseudouridine into mRNA enhances translation by diminishing PKR activation. Nucleic acids research 38, 5884, 2010.
Karikó, K., Muramatsu, H., Ludwig, J., and Weissman, D: Generating the optimal mRNA for therapy: HPLC purification eliminates immune activation and improves translation of nucleoside-modified, protein-encoding mRNA. Nucleic acids research 39, e142, 2011.
Anderson, B. R., Muramatsu, H., Jha, B. K., Silverman, R. H., Weissman, D., and Karikó, K: Nucleoside modifications in RNA limit activation of 2'-5'-oligoadenylate synthetase and increase resistance to cleavage by RNase L. Nucleic acids research 39, 9329, 2011.
Karikó, K., Muramatsu, H., Keller, J. M., and Weissman, D: Increased erythropoiesis in mice injected with submicrogram quantities of pseudouridine-containing mRNA encoding erythropoietin. Mol Ther 20, 948, 2012.
Pardi, N., Tuyishime, S., Muramatsu, H., Karikó, K., Mui, B. L., Tam, Y. K., Madden, T. D., Hope, M. J., and Weissman, D: Expression kinetics of nucleoside-modified mRNA delivered in lipid nanoparticles to mice by various routes. J Control Release 217, 345, 2015.
Sahin, U., Karikó, K., and Türeci, Ö: mRNA-based therapeutics--developing a new class of drugs. Nat Rev Drug Discov 13, 759, 2014.
Stadler, C. R., Bahr-Mahmud, H., Celik, L., Hebich, B., Roth, A. S., Roth, R. P., Karikó, K., Tureci, Ö., and Sahin, U: Elimination of large tumors in mice by mRNA-encoded bispecific antibodies. Nature Medicine 23, 815, 2017.
Pardi, N., Hogan, M. J., Pelc, R. S., Muramatsu, H., Andersen, H., DeMaso, C. R., Dowd, K. A., Sutherland, L. L., Scearce, R. M., Parks, R., Wagner, W., Granados, A., Greenhouse, J., Walker, M., Willis, E., Yu, J. S., McGee, C. E., Sempowski, G. D., Mui, B. L., Tam, Y. K., Huang, Y. J., Vanlandingham, D., Holmes, V. M., Balachandran, H., Sahu, S., Lifton, M., Higgs, S., Hensley, S. E., Madden, T. D., Hope, M. J., Karikó, K., Santra, S., Graham, B. S., Lewis, M. G., Pierson, T. C., Haynes, B. F., and Weissman, D: Zika virus protection by a single low-dose nucleoside-modified mRNA vaccination. Nature 543, 248, 2017.
Pardi, N., Secreto, A. J., Shan, X., Debonera, F., Glover, J., Yi, Y., Muramatsu, H., Ni, H., Mui, B. L., Tam, Y. K., Shaheen, F., Collman, R. G., Karikó, K., Danet-Desnoyers, G. A., Madden, T. D., Hope, M. J., and Weissman, D: Administration of nucleoside-modified mRNA encoding broadly neutralizing antibody protects humanized mice from HIV-1 challenge. Nat Commun 8, 14630, 2017.
Baiersdörfer, M., Boros, G., Muramatsu, H., Mahiny, A., Vlatkovic, I., Sahin, U., and Karikó, K: A Facile Method for the Removal of dsRNA Contaminant from In Vitro-Transcribed mRNA. Mol Ther Nucleic Acids 15, 26, 2019.
Sahin, U., Muik, A., Derhovanessian, E., Vogler, I., Kranz, L. M., Vormehr, M., Baum, A., Pascal, K., Quandt, J., Maurus, D., Brachtendorf, S., Lorks, V., Sikorski, J., Hilker, R., Becker, D., Eller, A. K., Grutzner, J., Boesler, C., Rosenbaum, C., Kuhnle, M. C., Luxemburger, U., Kemmer-Bruck, A., Langer, D., Bexon, M., Bolte, S., Karikó, K., Palanche, T., Fischer, B., Schultz, A., Shi, P. Y., Fontes-Garfias, C., Perez, J. L., Swanson, K. A., Loschko, J., Scully, I. L., Cutler, M., Kalina, W., Kyratsous, C. A., Cooper, D., Dormitzer, P. R., Jansen, K. U., and Tureci, O: COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses. Nature 586, 594, 2020.
Sahin, U., Muik, A., Vogler, I., Derhovanessian, E., Kranz, L. M., Vormehr, M., Quandt, J., Bidmon, N., Ulges, A., Baum, A., Pascal, K., Maurus, D., Brachtendorf, S., Lörks, V., Sikorski, J., Koch, P., Hilker, R., Becker, D., Eller, A.-K., Grützner, J., Tonigold, M., Boesler, C., Rosenbaum, C., Heesen, L., Kühnle, M.-C., Poran, A., Dong, J. Z., Luxemburger, U., Kemmer-Brück, A., Langer, D., Bexon, M., Bolte, S., Palanche, T., Schultz, A., Baumann, S., Mahiny, A. J., Boros, G., Reinholz, J., Szabó, G. T., Karikó, K., Shi, P.-Y., Fontes-Garfias, C., Perez, J. L., Cutler, M., Cooper, D., Kyratsous, C. A., Dormitzer, P. R., Jansen, K. U., and Türeci, Ö: BNT162b2 induces SARS-CoV-2-neutralising antibodies and T cells in humans. Nature 595, 572, 2021.
Krienke, C., Kolb, L., Diken, E., Streuber, M., Kirchhoff, S., Bukur, T., Akilli-Öztürk, Ö., Kranz, L. M., Berger, H., Petschenka, J., Diken, M., Kreiter, S., Yogev, N., Waisman, A., Karikó, K., Türeci, Ö., and Sahin, U: A noninflammatory mRNA vaccine for treatment of experimental autoimmune encephalomyelitis. Science 371, 145, 2021

Lectures by invitation (last 5 years)

 
Katalin Karikó has given more than 30 lectures by invitation at international and national scientific conferences and symposia (e.g., mRNA Health Conference, Cold Spring Harbor, RNA Medicine Symposium).
2016
In vitro-transcribed mRNA for therapy and vaccination – Imperial College, London, UK
New frontiers: mRNA therapy – possible implications in burn wound treatment – 26th Conference of the European Wound Management Association, Bremen, Germany
Optimal mRNA in the making: RNA in clinical trials – 4th mRNA Health Conference, Boston, USA
Messenger RNA for therapy – RNA-Medicine: From RNA Discoveries to Future Therapies Berlin, Germany
2017
mRNA-based protein replacement therapies – Cluster for Individualized Immune Intervention (Ci3), Mainz, Germany
Developing mRNA therapy for protein replacement – RNA & Oligonucleotide Therapeutics, Cold Spring Harbor Laboratory, NY, US
From bench to bedside: In vitro transcribed mRNA for therapy – University of Debrecen, Hungary
In vitro transcribed mRNA for therapy – SFNano Summer School: Nucleic acids-based strategies to control gene expression, La Grande Motte, France
In vitro transcribed mRNA for therapy – Transgene, Illrich France
In vitro transcribed mRNA for therapy – Symposium of Medical RNomics University of Giessen, Giessen, Germany
2018
mRNA therapy – Icahn School of Medicine at Mount Sinai, NYC, USA
mRNA-based protein replacement therapy – Masters Seminar Series, University of Giessen, Germany
Modified mRNA platform – Pfizer, Pearl River, NY, USA
2020
My story of the mRNA – mRNA Day TriLink, San Diego, CA, USA
2021
Development mRNA for therapy – UC Davis, Carrol C. Cross Distinguished Professorship lecture series, virtual presentation
Development mRNA for therapy – Brandeis University, USA, virtual presentation
Development mRNA for therapy – Pfizer, North America Medical Affairs, virtual
Az mRNS fejlesztése terápiára – Hungarian Academy of Sciences, opening the 194th year of the Academy, Budapest, Hungary
Development mRNA for therapy – 6th Annual RNA Medicine 2021Symposium, Beth Israel Deaconess Medical Center, virtual presentation
Developing mRNA for Therapy – Harvard Medical School, virtual symposium
Immune activation by RNA – Keystone Symposia, DAMPs Across the Tree of Life Inducing Innate Immunity, virtual presentation Az mRNS fejlesztése terápiára – Magyar Higiénikusok Társasága, Fodor József emlékülés
Development of the mRNA Therapeutic - Not Warp Speed! – Rosalind Franklin Society, Women in Science lecture, virtual presentation

Honors and Awards

2021
Rosenstiel Award for Distinguished Work in Medical Science, Brandeis University
2021
Reichstein medal, Swiss Academy of Pharmaceutical Sciences
2021
Jedlik Ányos Award, Hungarian Intellectual Property Office
2021
Fodor József Award, Hungarian Society of Hygiene
2021
Princess of Asturias Award, Princess of Asturias Foundation, Spain
2021
Széchenyi Prize, Hungarian Government
2021
Semmelweis Award, Hungarian Government
2021
Public Health Award, Research!America’s Outstanding Achievement
2021
Wilhelm Exner Medal, Austrian Trade Association
2021
Honorary Doctoral Degree, University of Szeged, Hungary
2022
Vilcek Prize for Excellence in Biotechnology, Vilcek Foundation

Contact

Press

Julia Bloes
Manager Corporate Communications
BioNTech SE
An der Goldgrube 12
55131 Mainz
Phone: +49 (0) 6131 / 90 840
E-Mail: media@biontech.de
Web: www.biontech.de

A description provided by the institutes and companies regarding their nominated projects

In December 2020, BioNTech received the world’s first emergency or conditional market authorizations for its COVID-19 vaccine, the world’s first mRNA product. By developing the first mRNA drug, the company made medical history. BioNTech’s decades of research and development of immunotherapies are now making a difference in a way that the company always wanted to: for people around the world.

Prof. Dr. Ugur Sahin, Dr. Özlem Türeci and Dr. Christoph Huber founded BioNTech in 2008 as an immunotherapy company with the vision of ushering in a new era of immunotherapies and developing innovative approaches against cancer and infectious diseases. They were supported by Dr. Thomas and Dr. Andreas Strüngmann, Michael Motschmann and Helmut Jeggle. Dr. Katalin Karikó joined BioNTech in 2013 as Senior Vice President. In their work as practicing physicians, Dr. Sahin and Dr. Türeci have witnessed that innovations from science and research too rarely reach cancer patients. Then and now are they pursuing the goal of using their research findings to develop solutions that improve the health of people worldwide by harnessing the full potential of the immune system.

With its founding, BioNTech began developing individualized as well as off-the-shelf cancer therapies. 2020 was a transformative year for BioNTech. In 2020, in what the company called “Project Lightspeed”, BioNTech developed a well-tolerated and effective vaccine for all mankind to address the COVID-19 pandemic. In doing so, the team demonstrated not only the potential of mRNA technology, but also the success of decades of research.

Project Lightspeed: The Development of the COVID-19 Vaccine

When the coronavirus spread in early 2020, there were some indications that it could beocme a global pandemic. BioNTech felt it had a duty to leverage its research expertise and make an important contribution to addressing the emerging global health crisis. BioNTech contributed the technology and expertise in immunology, while its partners Pfizer and Fosun Pharma drew on their established infrastructure, working with BioNTech to successfully conduct clinical trials and establish manufacturing and distribution.

A breakthrough has truly been achieved at the speed of light. In less than a year, BioNTech and its partner Pfizer developed a vaccine – a process that usually takes five to ten years. This was by far the fastest vaccine development in the history of medicine – without taking any shortcuts.

 

The vaccine is now being supplied to more than 100 countries. By end of July, 2021, more than 1 billion doses of the COVID-19 vaccine have already been delivered. For 2021 BioNTech, together with its partners Pfizer and Fosun, has so far signed orders for more than 2 billion doses. In addition, 2 billion doses of vaccine will be provided to low- and middle-income countries. For low-income countries, the vaccine will be offered at a “not-for-profit” price.

The company achieved numerous milestones on the road to approval of the COVID-19 vaccine. This was made possible by the following key factors:

Rapid development: BioNTech was the first company to bring an mRNA-based vaccine into clinical development in Europe. The vaccine was also the world’s first COVID-19 vaccine to receive conditional and emergency authorizations following the successful completion of the Phase 3 trial. BioNTech did not take any shortcuts during development, testing and regulatory approval, but successfully worked with all partners and regulatory agencies to reduce wait times and minimize idle time.

High efficacy and safety: Data from studies of vaccinations in Israel show that the vaccine not only offers more than 97 percent protection against symptomatic disease, severe disease and deaths, but also 94 percent protection against infection with SARS-CoV-2.

Quick adaptability: Studies of the variants observed to date demonstrate that the vaccine also protects effectively against newly emerging variants of the virus. Moreover, should an adaptation of the vaccine nevertheless become necessary, the mRNA vaccine platform enables a quick and flexible adaptation of the vaccine within six weeks.

Scaled-up production capacity: To achieve the goal of making the vaccine available worldwide, BioNTech scaled up production capacity in 2020 as early as possible and as quickly as possible. To this end, the company, at its own risk, acquired a production facility from Novartis in Marburg early on and expanded its global manufacturing and supplier network to include more than a dozen partners. This will enable the company to produce up to one billion doses of COVID-19 vaccine in 2021 through BioNTech’s own production network alone. For 2021, BioNTech expects a total production capacity of up to three billion doses.

Outlook: Harnessing the potential of the human immune system

Based on the knowledge gained from the vaccine program, research can be advanced even faster and more broadly in the future. After all, the global pandemic effort has set new standards for the development of vaccines and therapeutics.

BioNTech intends to build on this in future research. The clear goal is to bring further novel therapies in the areas of oncology and infectious diseases to market maturity within the next five years. In the long term, BioNTech also sees applications for technologies in allergies, inflammatory diseases, and even regenerative medicine. BioNTech established research programs in these areas early on and plans to expand them further in the coming years.

As immune engineers, BioNTech’s scientists and researchers continue to consistently pursue the vision of improving the health of people around the world by harnessing the full potential of the immune system.

 

About BioNTech

Biopharmaceutical New Technologies is a next-generation immunotherapy company pioneering the development of therapies for cancer and other serious diseases. The company combines a variety of advanced therapeutic platforms and bioinformatics tools to rapidly advance the development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates includes individualized therapies as well as off-the-shelf mRNA-based drugs, innovative chimeric antigen receptor (CAR) T cells, bispecific checkpoint immunomodulators, targeted cancer antibodies and small molecules. Based on its extensive expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech is developing several mRNA vaccine candidates for a range of infectious diseases with collaboration partners, in addition to its diverse oncology pipeline. BioNTech works side-by-side with world-renowned pharmaceutical industry collaborators including Genmab, Sanofi, Bayer Animal Health, Genentech (a Roche company), Regeneron, Genevant, Fosun Pharma and Pfizer.
For more information, please visit: www.BioNTech.de.