Biontech

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Coordinates: 49 ° 59 '15.49 "  N , 8 ° 16' 17.93"  O

BioNTech SE

logo
legal form European society
ISIN US09075V1026
founding 2008
Seat Mainz , GermanyGermanyGermany 
management
  • Sean Marett, CBO & CCO
  • Sierk Poetting, COO
  • Jens Holstein, CFO
  • Ryan Richardson, CSO
Number of employees 1,941 (2020)
sales € 482.3 million (2020)
Branch biotechnology
Website https://biontech.de/de
As of December 31, 2020

Biontech headquarters, An der Goldgrube 12, Mainz-Oberstadt

The BioNTech SE (self spelling BioNTech formed from English Bio pharmaceutical N ew Tech nologies , Pronunciation baɪ.ɒn'tɛk or biːɒn'tɛk ) is since the end of 2019 listed German biotechnology company based in Mainz . It has focused on the development and manufacture of active immunotherapies for a patient-specific approach to the treatment of cancer and other serious diseases. Biontech focuses on research into drugs based on mRNA-Base. These can be used as individualized cancer immunotherapies , as vaccines against infectious diseases and as protein replacement therapies for rare diseases . In addition, the company is active in research into programmable cell therapies ("Engineered Cell Therapy"), novel antibodies and low-molecular immunomodulators ("Small Molecules") as treatment options for cancer.

Biontech is the first company to develop an mRNA -based human therapeutic agent for intramuscular administration, to bring individualized mRNA-based cancer immunotherapy into clinical studies and to establish its own manufacturing process for such a product candidate. From the beginning of 2020, Biontech developed the vaccine BNT162b2 (proposed international non-proprietary name Tozinameran ) against the human coronavirus SARS-CoV-2 , which is manufactured in Pfizer plants for worldwide use. It is the company's first product to be approved; According to the company, around 20 potential drugs are in the development phase.

story

Founding phase (2008-2013)

Biontech was founded in 2008 by Uğur Şahin , Özlem Türeci and Christoph Huber as BioNTech RNA Pharmaceuticals GmbH on the basis of many years of research, which was funded by the Federal Ministry of Research and others in the biotechnology start-up initiative (GO-Bio) . The focus of the company's activities is on the development and manufacture of technologies and drugs for individualized cancer immunotherapies . Participated in the foundation were Andreas and Thomas Strüngmann with an initial investment of around 180 million US dollars and Michael Motschmann and Helmut Jeggle. In 2009, EUFETS and JPT Peptide Technologies were taken over. In the same year, the clinical phase 1 studies with MERIT (melanoma RNA immunotherapy; fixed combination of cancer-specific antigens) and IVAC MUTANOME (first study with individualized neoepitopes) began. The initial seed financing was completed in 2009 .

Expansion of the platforms (2014-2018)

Between 2014 and 2018, extensive publications of the research results were carried out, among other things. in Nature. In addition, from 2015 extensive collaborations and joint development programs and commercialization programs were concluded with various companies and scientific institutions. Biontech applied for several patents during this period and developed a multi-layered strategy to ensure the protection of its intellectual property in the various technology platforms and their application in the treatment of cancer and other serious diseases.

IPO on Nasdaq (2019)

In 2019, the company went public on the Nasdaq . Since October 10, 2019, Biontech has been publicly traded as American Depository Shares (ADS) on the Nasdaq Global Select Market under the ticker symbol BNTX . Biontech is one of eight German companies that are listed on the US technology exchange. Before that, one of the largest European Series B financings was concluded in July. Biontech generated gross proceeds of $ 150 million from its IPO. Originally, proceeds of $ 250 million were expected from the IPO. Consortium were the investment banks J.P.Morgan , Merrill Lynch , UBS and SVB Leerink . With a valuation of around 3.1 billion euros based on the issue price of 15 dollars per share, Biontech was able to establish itself in the top group of the German biotech scene on the basis of market capitalization.

In 2019, six clinical studies were initiated that use four therapeutic platforms and cover two classes of active ingredients. A total of ten product candidates were processed in eleven clinical studies in 2019. In addition, the antibody production business of MAB Discovery, antibody assets of MabVax Therapeutics and Lipocalyx were acquired in 2019.

COVID-19 vaccine (since 2020)

Vial of COVID-19 vaccine, December 2020

After the outbreak of a new virus in China became public at the beginning of 2020 , the global development project Lightspeed began in mid-January to develop a well-tolerated, potent vaccine against the SARS-CoV-2 virus in the shortest possible time. In mid-March 2020, Biontech agreed alliances with two partners for testing and subsequent marketing: Fosun Pharma (Shanghai) for the Chinese market and Pfizer for the rest of the world. Studies have also been initiated in the USA, Europe, China, Latin America and South Africa. The first clinical tests were carried out in April 2020. In November 2020, Biontech announced that the coronavirus vaccine developed together with Pfizer was over 95% effective in protecting against the disease COVID-19 . On December 1, 2020, the European Medicines Agency announced that it had received a conditional marketing authorization application for BNT162b2. The following day, the UK announced an emergency approval of the vaccine and vaccinations would start the following week.

In September 2020, Biontech received government funding from the Federal Ministry of Education and Research to accelerate the production of COVID-19 vaccines. These amount to up to 375 million euros. The European Investment Bank also supported Biontech with a loan of 100 million euros. As of February 2021, however, the company had only used just under a third of the federal grant to expand production.

On December 21, 2020, BNT162b2 was granted conditional marketing authorization by the European Commission . The vaccine has been officially used in Germany and other EU countries since December 27, 2020.

structure

Biontech's business is managed in two overarching business units, the Biotech Business Unit and the External Services Business Unit . The External Services division comprises all activities related to the sale of diagnostic products, peptides , retroviral vectors for clinical care as well as development and production services that are provided for third-party customers.

Share and shareholders

Biontech's shares have been publicly traded as American Depository Shares (ADS) on the Nasdaq Global Select Market since October 10, 2019. In the run-up to the IPO and with effect from March 8, 2019, the company was converted from an AG to an SE . With a stake of over 50%, AT Impf, an investment company owned by Andreas and Thomas Strüngmann , is the largest single shareholder. Other institutional investors associated with the members of the management board and the supervisory board are Medine, MIG Verwaltung and FMR. Overall, the companies of these committee members hold almost 72% of the shares in Biontech. In August 2021, the market value was more than $ 100 billion.

Bodies

board of directors

As of July 2021, Biontech's board of directors will consist of six members. Since inception, Uğur Şahin CEO ( Chief Executive Officer ). Other members are: Sean Marett (since 2012, Chief Business Officer and Chief Commercial Officer), Sierk Poetting (since 2014, Chief Financial Officer (until the end of June 2021) and Chief Operating Officer ), Özlem Türeci (since 2018; Chief Medical Officer) , Ryan Richardson (since 2020, Chief Strategy Officer ) and Jens Holstein (from July 2021 Chief Financial Officer ).

Supervisory board

The supervisory board consists of four members. The chairman is Helmut Jeggle, who has been employed in leading positions at Athos Service since 2007. He has been Chief Executive Officer and Chief Operating Officer there since 2015. He previously held various positions at Hexal . Further members are Ulrich Wandschneider (since 2018, Chief Executive Officer of Asklepios Kliniken from 2011 to 2016 ), Michael Motschmann (since 2008, co-founder of the MIG administration) and Christoph Huber (Austrian hematologist , oncologist and immunologist with a research focus on tumor defense and stem cell transplantation ). From 1990 until his retirement in 2009 he was director of the III. Medical clinic and polyclinic at the University Medical Center of Johannes Gutenberg University Mainz .

Scientific Advisory Board

Biontech has been supported by a scientific advisory board led by Rolf Zinkernagel and Hans Hengartner since it was founded . Rolf Zinkernagel is a professor emeritus at the University of Zurich and former head of the Institute for Experimental Immunology in Zurich . In 1996, Zinkernagel received the Nobel Prize for his discovery of how the immune system recognizes virus-infected cells. Hengartner is an immunologist and professor emeritus at the Swiss Federal Institute of Technology (ETH) Zurich and the University of Zurich.

Locations

Biontech's headquarters are in the Oberstadt district of Mainz . The company headquarters was built on the site of the Generalfeldzeugmeister barracks, which will be completely cleared by the Bundeswehr by 2022. In March 2020, Biontech already acquired additional properties in Mainz in order to be able to expand. The company operates several GMP -certified production facilities in Germany for the manufacture of mRNA therapeutics and programmable cell therapies ("Engineered Cell Therapies"). The locations are Idar-Oberstein (BioNTech Innovative Manufacturing Services) , Martinsried (BioNTech Small Molecules) , Neuried (Biontech) and a fourth facility in Berlin that offers peptide-based services and products for various areas of biomedical research (JPT Peptide Technologies) .

In 2019, the locations were expanded to include a subsidiary in San Diego , USA (BioNTech Research & Development) . In 2020 Neon Therapeutics was acquired and become BioNTech US . Founded in 2015 by scientists including a Nobel Prize winner, Neon was based on knowledge gained in developing neon antigen therapies with a focus on vaccines and T-cell therapeutics. The complementary skills and resources for neon antigen-based therapeutics in the areas of cancer medicine and immunology were thereby combined. The merger enabled Biontech to further expand its capabilities in the T-cell receptor field and to strengthen its position in the field of programmable T-cell therapies. Neon common shares were removed from trading in May 2020. BioNTech US is based in Cambridge , Massachusetts and is a fully integrated subsidiary, strengthening Biontech's presence in the USA.

In 2021, Biontech bought a cell therapy manufacturing facility and research platform for TCR cell therapies in Gaithersburg from Kite Pharma .

Biontech Manufacturing Marburg

In September 2020, Novartis Vaccines and Diagnostics sold its plant in Marburg to Biontech, which has since been run as Biontech Manufacturing Marburg . The plant in Marburg is a modern multi-platform GMP -certified production facility that employs around 300 people. It is equipped for the production of recombinant proteins as well as for cell and gene therapies and has cell culture laboratories and production capabilities for the production of viral vectors, with the possibility of expanding them in the long term. The takeover of the plant enables Biontech to expand its commercial production capacities for the manufacture of the mRNA-based COVID-19 vaccine candidate BNT162. In addition to two GMP-certified sites that already exist at Biontech that have produced COVID-19 vaccine candidates for clinical studies, the facility is to become one of the largest production sites for mRNA in Europe. The production of the mRNA and the lipid - nanoparticle formulation of a COVID-19 vaccine is to begin in Marburg in February 2021. The responsible regional council of Giessen approved the operation of the plant from an environmental point of view on January 15, 2021. The pharmaceutical approval from the Darmstadt Regional Council was granted on January 28, 2021. Three of the four required production steps take place at the site. An annual production of 750 million vaccine doses is planned. On March 26, 2021, Biontech Manufacturing Marburg received EMA approval as one of three manufacturing locations for Comirnaty.

The production facility in Marburg goes back to Emil von Behring , who had a private laboratory built in 1904, from which the Behring factories emerged . Behring developed the antidote for diphtheria and tetanus and used the prize money he received for his Nobel Prize in Medicine in 1901 to finance the production facility.

On May 10, 2021, Biontech announced in a press release that it wanted to expand its global presence to Asia with the establishment of a regional Southeast Asia headquarters in Singapore. An mRNA production facility is to be built there with the support of the Singapore Economic Development Board. Its aim is to create regional and global supply capacities for mRNA-based vaccines and therapeutics against infectious diseases and cancer. Construction is scheduled to start in 2021; The plant should be ready for operation in 2023. Initially, a capacity of several hundred million vaccine doses per year is planned.

Key figures & employees

year 2017 2018 2019 2020
Turnover (million euros) 69.5 150.5 121.5 482.3
Employee 710 1,026 1,323 1.941
- Research and Development 511 729 973
- production 120 168 178
- Administration 65 93 144
- Sales and marketing 14th 36 28

Source: Annual reports 2019 and 2020

In the first quarter of 2021, Biontech reported a quarterly profit of 1.1 billion euros. Compared to the fourth quarter of 2020 (EUR 366.9 million), this corresponds to a threefold increase in net profit. Biontech sales reached an estimated 2.05 billion euros in the first quarter of 2021, more than 70 times as much as in the corresponding period of 2020 (27.7 million euros). As of May 6, 2021, more than 450 million Biontech-Pfizer vaccine doses had been shipped to 91 countries or regions worldwide.

In December 2019, over 1,300 employees from over 60 countries worked at Biontech. The proportion of women was over 56%; a quarter of the employees had a doctorate . The average age is around 35 years. Well-known employees include Katalin Karikó , Senior Vice President at Biontech since 2013, and Alexandra Kemmer-Brueck.

Research and technology

Biontech's research approach is based on the view that the use of complementary, potentially synergistic mechanisms of action increases the likelihood of therapeutic success, reduces the risk of secondary resistance mechanisms and also opens up a larger potential market. A technology-agnostic approach is decisive for the provision of the most suitable therapeutic platform or a platform combination for the respective patient and his illness, and bioinformatics for the production of individualized therapies. The validated patient-centered bioinformatics process enables the application of complex algorithms to patient data in the context of drug production. The bioinformatics processes are robust, scalable and rely on experience in handling genome data with high data processing rates. Biontech's research is intended to enable the production of individualized on-demand immunotherapies for commercial use.

mRNA therapeutics

Biontech is researching active ingredients based on the messenger molecule messenger RNA (mRNA) as a potential new class of drugs. mRNA brings genetic information to the ribosomes , the place in the cell where proteins are made. In the ribosomes, the genetic information of the mRNA is translated into corresponding proteins. The first mRNA-based product candidates have already entered clinical development as cancer immunotherapeutics and vaccines against infectious diseases . As a drug, the produced mRNA delivers instructions to a target cell to produce a desired therapeutic protein. In the treatment of cancer, the protein produced is directed against target structures that are derived directly from mutations in the cancer cells. This is the way to fight cancer.

Biontech has developed several formats and formulations of mRNA to deliver genetic information to cells, where it is used in the body's own production of proteins for therapeutic purposes. Biontech is researching several mRNA-based therapy platforms for cancer immunotherapy, in particular for individualized cancer immunotherapy.

The paradigm shift to individualized immunotherapy is to be initiated with four classes of active ingredients. Biontech pursues the approach of combining different mechanisms of action of the different drug classes to make cancer treatment more coordinated and more precise than is possible with the therapies currently available. Five different platforms for the treatment of cancer are to emerge from the four different mRNA formats.

mRNA formats

Optimized unmodified mRNA (uRNA)

The nucleotide sequence of the mRNA determines the amino acid sequence of the protein. In addition, the type of nucleoside used to make mRNA drugs can also affect how the molecule is recognized by the immune system.

Nucleoside- modified mRNA (modRNA)

Immunogenic reactions against active mRNA substances must be avoided in applications in which therapeutic proteins are produced, for example on the two Biontech platforms RiboMabs and RiboCytokines.

Self-amplifying mRNA (saRNA)

The product candidates with self-amplifying mRNA (saRNA) are based on the concept of virus replication, but according to the manufacturer, they are themselves neither infectious nor pathogenic. saRNA is similar to conventional mRNA: On the one hand, it codes the respective protein, but also a polymerase. This so-called replicase multiplies part of the mRNA within the target cell. During the self-amplification within the cell, a double-stranded RNA is formed as an intermediate stage, which is recognized by intracellular immune sensors. As a result, according to the company, a very strong activation of the immune system can be achieved with saRNA.

Transamplifying mRNA (taRNA)

This technology is a further development of the saRNA platform. By separating the target mRNA to be amplified from the replicase-coding mRNA, the range of applications is to be expanded, according to the manufacturer. This makes the development of therapeutic mRNAs even more flexible, as the replicase can amplify mRNA that encodes not just one protein but several different proteins.

mRNA platforms

Three of the platforms are currently in clinical trials.

  • FixVac, a standard immunotherapy based on common antigens owned by Biontech
  • iNeST, an individualized neoantigen-specific immunotherapy in collaboration with Genentech
  • intratumoral immunotherapy in collaboration with Sanofi

Two more platforms are also in development.

  • RiboMabs, a new class of mRNA-encoded monoclonal antibodies that aim to use the corresponding mRNA to produce the desired antibodies directly in the patient's body.
  • RiboCytokines, a new class of mRNA-based therapeutics designed to be translated into cytokines directly in the patient. Cytokines play a central role in controlling the immune response to pathogens and malignant cells.

Programmable cell therapies

Biontech is developing a number of new cell therapies (engineered cell therapies) to modify the patient's T cells in such a way that they target cancer- specific antigens . Research is being conducted into programmable cell therapies and an expanded patient universe. A number of new cell therapies are being developed in which the patient's T cells are modified in such a way that they target cancer-specific antigens. These include two platforms for the treatment of solid tumors: a platform for T cells with chimeric antigen receptor (CAR T cells) and a platform for T cell receptor (TCR) programs. Biontech is investigating, among other things, a CAR-T product candidate, BNT211, which is directed against Claudin-6 (CLDN6). The antigen CLDN6 is specific for solid tumors.

antibody

Biontech is developing next generation antibodies ( checkpoint immunomodulators and targeted cancer antibodies) to modulate the patient's immune response to cancer.

In collaboration with Genmab , Biontech is researching bispecific antibodies that act as dual immunomodulators . For this purpose, the company uses the DuoBody technology developed by Genmab. In 2019, Biontech acquired an antibody (MVT-5873 or BNT321) with a novel mode of action from MabVax. BNT321 is a fully human monoclonal IgG1 antibody that is directed against Sialyl Lewis A (sLea). sLEA is a newly identified epitope that is specifically expressed in pancreatic cancer and other solid tumors .

Small molecule immunomodulators

BioNTech explores small molecules (small molecules) to specific immunomodulation . The aim is to increase the activity of other active ingredients through immune modulation. In this context, the company is developing a small- molecule toll-like receptor-7 (TLR7) -based immunomodulator for the treatment of solid tumors. TLR7 plays an important role in activating the innate immune response . In many types of cancer, tumors are protected by an anti-inflammatory environment. This reduces the immune system's ability to attack cancer cells. TLR7 agonists can trigger a direct cellular immune response here . Small molecule immunomodulators, or low molecular weight cancer therapeutics, can be used to control the growth of cancerous tumors, stop the formation of blood vessels in tumors, and deliver toxins to cancer cells. They are also suitable as markers for cancer cells in order to make them recognizable for the immune system and to destroy them. In contrast to cancer therapies with larger antibody molecules, low molecular weight compounds are often directed against target structures inside cells.

The research is carried out by Biontech Small Molecules in Martinsried.

Areas of application

oncology

Cancer is caused by abnormalities called somatic mutations . These mutations can accumulate in the genome of cells over time and lead to malignant transformation . The process of carcinogenesis involves the inability of the immune system to recognize and eradicate such transformed cells.

The aim of immunotherapy in oncology is to use the immune system to recognize malignant cells as "foreign" and to overcome mechanisms with which the cancer cells evade the immune system . The immune system should be activated in such a way that it is able to limit tumor growth and destroy malignant cells. Due to their random nature, carcinogenic genetic changes lead to a set of mutations (the “mutanoma”) that are unique to each patient's tumor . Research uses the patient-specific mutanome to develop drugs for individualized cancer immunotherapy . The treatment is tailored to the individual patient. The development of cancer immunotherapies that are individually tailored to each patient is the focus of Biontech's research activities.

Technologies such as next-generation sequencing (NGS for short) have undoubtedly confirmed the problematic diversity of tumors on the inter-individual patient level. At the same time, NGS enables fast, inexpensive and precise high-resolution mapping of a patient's individual illness. The application of these breakthrough technologies is transforming drug development. It has the potential to significantly change the oncological treatment landscape. It is possible to incorporate a comprehensive molecular mapping of tumor genes into treatment decisions and thus to make individualized therapeutics available. This is at the heart of developing the next generation of cancer therapies.

Infectious diseases

In addition to the oncology area , Biontech has also implemented mRNA platforms for the development of mRNA-based vaccines against pathogens that cause infectious diseases . The infectious disease vaccine candidates contain modified mRNA-encoding antigens that are specific for a target pathogen in order to activate and instruct T-cells and B-cells to fight the pathogen.

There are collaborations with Pfizer and the University of Pennsylvania. In August 2019, Biontech signed an investment agreement with the Bill & Melinda Gates Foundation to advance the development of immunotherapies to prevent and / or treat HIV , tuberculosis and up to three other infectious diseases.

On March 17, 2020, Pfizer and Biontech announced an agreement to jointly develop and distribute a potential mRNA-based coronavirus vaccine to prevent COVID-19 infection. For this purpose, the Paul Ehrlich Institute approved a phase 1/2 clinical study for the BNT162 vaccine program on April 22, 2020 . A first group of twelve subjects received the first vaccination by the end of April.

The results of the registration study of the coronavirus vaccine were published on November 18, 2020. The reported effectiveness is therefore 95 percent. The risk for study participants of developing Covid-19 was 95 percent lower than without vaccination. Serious side effects did not occur. In November, applications were made for emergency approval in the United States and the European Union. On December 2nd, the Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional approval for the United Kingdom . Approval by the European Commission for the 27 states of the European Union followed on December 21st .

Rare and other diseases

In the field of rare diseases , Biontech has implemented platforms for the development of mRNA -based protein replacement therapies . The aim is to code and manufacture the required proteins directly in the patient's body using the mRNA. Biontech shares the costs and profits with Genevant Sciences. The protein-based replacement therapies were developed to treat rare diseases through the administration of recombinant proteins. Such therapies are limited to diseases in which the lack of protein function is extracellular. However, mRNA-based protein replacement therapy also has the potential to treat diseases with intracellular protein defects, as long as the mRNA can be introduced into the affected cells.

Biontech uses several protein replacement platforms for rare diseases:

  • Concept: therapeutic proteins that are encoded by mRNA and produced in the patient as an alternative to recombinant protein replacement.
  • mRNA format: nucleoside-modified mRNA , deimmunized to avoid immune activation in order to allow translation of the therapeutic protein in the cells.
  • mRNA Delivery Formulation: Liver Targeting Lipid Nanoparticles (LNP).

Cooperations

Biontech has several collaboration agreements with biopharmaceutical and scientific partners to expand the resources in the fields of science and development. These include several agreements that enable Biontech to retain significant control over its development programs and to participate in the future of the products. The aim is to expand the potential of the technology platforms and to use the extensive applicability of the mRNA drug class beyond cancer therapy in other areas of indication. The collaborations concern both the oncology area and the areas of infectious diseases and rare diseases. Biopharmaceutical partners include: Genentech , Sanofi , Genmab , Genevant Sciences, Eli Lilly , Bayer and Pfizer . In addition, Biontech maintains research collaborations with the University of Pennsylvania ("Penn") and the research institute TRON ( Translational Oncology ) at the University Medical Center of Johannes Gutenberg University Mainz .

Affiliate programs

  • Genmab : Biontech's first cooperation was signed in May 2015 with Genmab, a license and cooperation agreement. The aim of the agreement is the joint research, development and marketing of bispecific antibodies based on polypeptides. These are intended to be used against certain target structure combinations for the treatment of cancer patients around the world. The first product candidate has been investigated in a phase 1 / 2a study in solid tumors since June 2019.
  • Eli Lilly : Together with Eli Lilly and Company, new tumor target structures and associated T-cell receptors (TCRs) have been developed since May 2015.
  • Siemens : Biontech has had a strategic partnership with Siemens since June 2015. The aim is to set up a fully automated, paperless and digitized commercial cGMP production facility for individualized vaccines.
  • Sanofi : In November 2015, Biontech and Sanofi signed an agreement for the licensing as well as the joint development and marketing of mRNA-based therapeutics for intratumoral application in solid human tumors. In March 2018, Sanofi selected the first product candidate for further development and marketing. For this candidate, who entered clinical development in January 2019, an option right to joint development and marketing was exercised.
  • Bayer Animal Health : Biontech has been working with Bayer Animal Health since May 2016 to develop novel “ first-in-class ” mRNA vaccines and therapeutics specifically for use in animals.
  • Genentech : In September 2016, a cooperation agreement was signed with Genentech and F. Hoffman-La Roche. The aim of the agreement is to jointly research, develop, manufacture and market certain pharmaceutical products containing neoepitope mRNAs for global use. This includes our development candidates for Individualized Neoantigen Specific Immunotherapy (iNeST).
  • Genevant : In July 2018, a collaboration was concluded with Genevant to develop mRNA-based therapeutics for rare diseases.
  • Pfizer : In collaboration with Pfizer, mRNA-based vaccines are being developed for the prevention of influenza. The agreement was announced in August 2018.
  • Bill & Melinda Gates Foundation (BMGF) : In August 2019, a research and development agreement was concluded with the BMGF in the field of HIV and tuberculosis as well as up to three other infectious diseases. The foundation's commitment can be up to USD 100 million. The funds will be used to identify and preclinically develop vaccine and immunotherapy candidates for the prevention of HIV and tuberculosis infections and for long-term antiretroviral therapy-free remission of HIV diseases.
  • InstaDeep : In November 2020, Biontech announced a strategic partnership with the British company, which in particular includes the establishment of an AI Innovation Lab to develop new immunotherapies.

Science and medicine

Biontech cooperates with a large number of universities and medical centers in Europe and the USA to carry out clinical studies .

  • Translational Oncology at the University Medical Center of Johannes Gutenberg University Mainz (TRON) is an independent biopharmaceutical research institute based in Mainz that develops new diagnostics and drugs for the treatment of cancer and other serious diseases.
  • Ci3 is a non-profit association with over 500 scientists, which networks actors from science, clinics and the relevant authorities. The aim is to implement groundbreaking individual immunotherapies.
  • German Center for Infection Research (DZIF) : The aim of the DZIF is to close the existing gap between the discovery of new treatment approaches, preclinical and clinical research.
  • Neoantigen initiative "Tumor Neoantigen Selection Alliance" (TESLA) of the Parker Institute for Cancer Immunotherapy. The non-profit brings together researchers from the fields of science, nonprofits, pharmacy and biotechnology to work together to treat the deadliest cancers.
  • University of Pennsylvania : A research cooperation with the university has existed since October 2018, under which Biontech has the exclusive option to develop and market mRNA immunotherapies for the treatment of up to ten indications of infectious diseases.

criticism

During a surge in COVID-19 infections in Taiwan in May 2021 and acute vaccine shortages, Taiwanese President Tsai Ing-wen accused the company of insisting on deleting "our country" from failed vaccine contract negotiations. However, the contract was not signed even when the request was met. This was seen in the media as a weakening of the independence of the Republic of China and the influence of the People's Republic on Biontech . Others saw legal reservations as a trigger, as the Chinese company Fosun Pharma already had exclusive marketing rights that also included the island area of ​​Taiwan .

Patents

In the area of ​​patents, Biontech has developed a multi-layered strategy to ensure the protection of intellectual property in the various technology platforms and their application in the treatment of cancer and other serious diseases. One focus of the intellectual property strategy is protecting the platforms and product candidates developed by Biontech that are under development. In this context, emphasis is also placed on the protection of intellectual property for assets that may be used in future development programs and / or that may be of interest to employees or that may otherwise prove of value in this area.

Biontech has more than 200 patent families wholly owned , including in-licensed patent portfolios and more than 100 patent families wholly or jointly owned by Biontech. All patents include at least one occupation in the EU or the US, several are pending in multiple countries or have been granted in multiple jurisdictions.

Biontech has held patents on mRNA for years. mRNA has been used successfully in medical and immunological applications, but is inherently very short-lived. Injected mRNA introduced from outside is normally broken down before it could start the protein production for the immune response using the pathogen's blueprint. For this purpose, a process was known and patented years ago that can stabilize the introduced mRNA very well. This was discovered and patented by a Polish team led by Jacek Jemielity, who entered into a partnership with Biontech in 2008, which further developed the process. Biontech has already licensed the stabilized mRNA technology to large pharmaceutical companies, including the French company Sanofi (in 2015) and Genentech (in 2016). Moderna , GSK and the two German companies Biontech and CureVac together own almost half of all patent applications for mRNA vaccines.

selection
  • Patent US9476055 : Modification of RNA, Producing an Increased Transport Stability and Translation Efficiency. Registered on September 28, 2006 , published on May 27, 2010 , applicant: BIONTECH AG, inventor: Sahin, Ugur; Holtkamp, ​​Silke; Tureci, Ozlem; Kreiter, Sebastian. ‌
  • Patent US9295717 : Vaccine Composition Comprising 5'-Cap Modified RNA. Registered on August 3, 2010 , published on August 2, 2012 , applicant: BioNTech, TRON - Translational Oncology at the University Medicine of Johannes Gutenberg University Mainz, Uniwersytet Warszawski, inventor: Sahin, Ugur; Kuhn, Andreas; Darzynkiewicz, Edward; Jemielity, Jacek; Kowalska, Joanna. ‌
  • Patent US14388192 : RNA Formulation for Immunotherapy. Registered on March 25, 2013 , published on March 26, 2015 , applicant: BioNTech RNA Pharmaceuticals, TRON - Translational Oncology at the University Medicine of Johannes Gutenberg University Mainz, inventor: Sahin, Ugur; Haas, Heinrich; Kreiter, Sebastian; Diken, Mustafa; Fritz, Daniel; Meng, Martin; Kranz, Lena Mareen; Reuter, Kerstin. ‌
  • Patent US14647577 : Individualized Vaccines for Cancer. Registered on November 26, 2013 , published on March 3, 2016 , applicant: BioNTech RNA Pharmaceuticals, TRON - Translational Oncology at the University Medicine of Johannes Gutenberg University Mainz, inventor: Sahin, Ugur; Paret, Claudia; Vormbrock, Kirsten; Bender, Christian; Diekmann, Jan.
  • Patent US10106800 : Modification of RNA, Producing an Increased Transcript Stability and Translation Efficiency. Registered on July 22, 2016 , published on January 12, 2017 , applicant: BioNTech, inventor: Sahin, Ugur; Holtkamp, ​​Silke; Tureci, Ozlem; Kreiter, Sebastian. ‌

Publications

mRNA therapeutics

  • S. Kreiter, A. Selmi, M. Diken, M. Koslowski, CM Britten, C. Huber, O. Tureci, U. Sahin: Intranodal vaccination with naked antigen-encoding RNA elicits potent prophylactic and therapeutic antitumoral immunity . In: Cancer Res . tape 70 , no. 22 , 2010, p. 9031-9040 , PMID 21045153 (English).
  • JC Castle, S. Kreiter, J. Diekmann, M. Lower, N. van de Roemer, J. de Graaf, A. Selmi, M. Diken, S. Boegel, C. Paret et al .: Exploiting the mutanome for tumor vaccination . In: Cancer Res . tape 72 , no. 5 , 2012, p. 1081-1091 , PMID 22237626 (English).
  • J. Kowalska, A. Wypijewska del Nogal, ZM Darzynkiewicz, J. Buck, C. Nicola, AN Kuhn, M. Lukaszewicz, J. Zuberek, M. Strenkowska, M. Ziemniak and others: Synthesis, properties, and biological activity of boranophosphate Analogs of the mRNA cap: versatile tools for manipulation of therapeutically relevant cap-dependent processes. In: Nucleic Acids Res . tape 42 , no. 16 , 2014, p. 10245-10264 , PMID 25150148 (English).
  • U. Sahin, K. Kariko, O. Tureci: mRNA-based therapeutics - developing a new class of drugs . In: Nat Rev Drug Discov . tape 13 , no. 10 , 2014, p. 759-780 , PMID 25150148 (English).
  • JC Castle, M. Loewer, S. Boegel, J. de Graaf, C. Bender, AD Tadmor, V. Boisguerin, T. Bukur, P. Sorn, C. Paret et al .: Immunomic, genomic and transcriptomic characterization of CT26 colorectal carcinoma . In: BMC Genomics . tape 15 , no. 190 , 2014, PMID 24621249 (English).
  • S. Kreiter, M. Vormehr, N. van de Roemer, M. Diken, M. Lower, J. Diekmann, S. Boegel, B. Schrors, F. Vascotto, JC Castle and others: Mutant MHC class II epitopes drive therapeutic immune responses to cancer . In: Nature . tape 520 , no. 7549 , 2015, p. 692-696 , PMID 25901682 (English).
  • MA Poleganov, S. Eminli, T. Beissert, S. Herz, JI Moon, J. Goldmann, A. Beyer, R. Heck, I. Burkhart, D. Barea Roldan and others: Efficient Reprogramming of Human Fibroblasts and Blood-Derived Endothelial Progenitor Cells Using Nonmodified RNA for Reprogramming and Immune Evasion . In: Hum Gene Ther . No. 11 , 2015, p. 751-766 , PMID 26381596 (English).
  • S. Grabbe, H. Haas, M. Diken, LM Kranz, P. Langguth, U. Sahin: Translating nanoparticulate-personalized cancer vaccines into clinical applications: case study with RNA-lipoplexes for the treatment of melanoma . In: Nanomedicine . No. 534 , 2016, p. 2723-2734 , PMID 27700619 (English).
  • U. Sahin, E. Derhovanessian, M. Miller, BP Kloke, P. Simon, M. Löwer, V. Bukur, AD Tadmor, U. Luxemburger, B. Schrörs, T. Omokoko, M. Vormehr, C. Albrecht, A. Paruzynski, AN Kuhn, J. Buck, S. Heesch, KH Schreeb, F. Müller, I. Ortseifer, I. Vogler, E. Godehardt, S. Attig, R. Rae, A. Breitkreuz, C. Tolliver, M. Suchan, G. Martic, A. Hohberger, P. Sorn, J. Diekmann, J. Ciesla, O. Waksmann, AK Brück, M. Witt, M. Zillgen, A. Rothermel, B. Kasemann, D. Langer , S. Bolte, M. Diken, S. Kreiter, R. Nemecek, C. Gebhardt, S. Grabbe, C. Höller, J. Utikal, C. Huber, C. Loquai, Ö. Türeci: Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer . In: Nature . No. 547 , 2017, p. 222-226 , PMID 28678784 (English).
  • CR Stadler, H. Bähr-Mahmud, L. Celik, B. Hebich, AS Roth, RP Roth, K. Karikó, Ö. Türeci, U. Sahin: Elimination of large tumors in mice by mRNA-encoded bispecific antibodies . In: Nature Medicine . 2017, p. 815-817 , doi : 10.1038 / nm.4356 (English).
  • N. Pardi, MJ Hogan, RS Pelc, H. Muramatsu, H. Andersen, CR DeMaso, KA Dowd, LL Sutherland, RM Scearce, R. Parks, W. Wagner, A. Granados, J. Greenhouse, M. Walker, E. Willis, JS Yu, CE McGee, GD Sempowski, BL Mui, YK Tam, YJ Huang, D. Vanlandingham, VM Holmes, H. Balachandran, S. Sahu, M. Lifton, S. Higgs, SE Hensley, TD Madden , MJ Hope, K. Karikó, S. Santra, BS Graham, MG Lewis, TC Pierson, BF Haynes, D. Weissman : Zika virus protection by a single low-dose nucleoside-modified mRNA vaccination . In: Nature . No. 543 , 2017, p. 248-251 , PMID 28151488 (English).

Programmable cell therapies

  • P. Simon, TA Omokoko, A. Breitkreuz, L. Hebich, S. Kreiter, S. Attig, A. Konur, CM Britten, C. Paret, K. Dhaene and others: Functional TCR retrieval from single antigen-specific human T cells reveals multiple novel epitopes . In: Cancer Immunol Res . tape 2 , no. 12 , 2014, p. 1230-1244 , PMID 25245536 (English).
  • T. Omokoko, P. Simon, O. Tureci, U. Sahin: Retrieval of functional TCRs from single antigen-specific T cells: Toward individualized TCR-engineered therapies . In: Oncoimmunology . tape 4 , no. 7 , 2015, PMID 26140230 (English).

antibody

Microbodies
  • S. Krause, HU Schmoldt, A. Wentzel, M. Ballmaier, K. Friedrich, H. Kolmar: Grafting of thrombopoietin-mimetic peptides into cystine knot miniproteins yields high-affinity thrombopoietin antagonists and agonists . In: FEBS J . 2007, p. 86-95 , PMID 17147697 (English).
  • O. Avrutina, HU Schmoldt, D. Gabrijelcic-Geiger, A. Wentzel, H. Frauendorf, CP Sommerhoff, U. Diederichsen, H. Kolmar: Head-to-tail cyclized cystine-knot peptides by a combined recombinant and chemical route of synthesis . In: Chembiochem . tape 9 , no. 1 , 2008, PMID 18058774 (English).
  • CP Sommerhoff, O. Avrutina, HU Schmoldt, D. Gabrijelcic-Geiger, U. Diederichsen, H. Kolmar: Engineered cystine knot miniproteins as potent inhibitors of human mast cell tryptase beta . In: J Mol Biol . tape 8 , no. 395 , 2010, doi : 10.1016 / j.jmb.2009.10.028 , PMID 19852971 (English).
Bispecific Antibodies
  • Christiane R Stadler, Hayat Bähr-Mahmud, Laura M Plum, Kathrin Schmoldt, Anne C Kölsch, Özlem Türeci, Ugur Sahin: Characterization of the First-in-Class T-Cell Engaging Bispecific Single-Chain Antibody for Targeted Immunotherapy of Solid Tumors Expressing the Oncofetal Protein Claudin 6 . In: OncoImmunology . 2015, doi : 10.1080 / 2162402X.2015.1091555 (English).
  • CR Stadler, H. Bähr-Mahmud, L. Celik, B. Hebich, AS Roth, RP Roth, K. Karikó, Ö. Türeci, U. Sahin: Elimination of large tumors in mice by mRNA-encoded bispecific antibodies . In: Nature Medicine . tape 23 , no. 7 , 2017, p. 815-817 , doi : 10.1038 / nm.4356 , PMID 28604701 (English).
Virus-Like-Particles
  • T. Klamp, J. Schumacher, G. Huber, C. Kuhne, U. Meissner, A. Selmi, T. Hiller, S. Kreiter, J. Markl, O. Tureci and others: Highly specific auto-antibodies against claudin-18 isoform 2 induced by a chimeric HBcAg virus-like particle vaccine kill tumor cells and inhibit the growth of lung metastases . In: Cancer Res . tape 71 , no. 2 , 2011, p. 516-527 , PMID 21224362 (English).
  • J. Schumacher, T. Bacic, R. Staritzbichler, M. Daneschdar, T. Klamp, P. Arnold, S. Jägle, Ö. Türeci, J. Markl, U. Sahin: Enhanced stability of a chimeric hepatitis B core antigen virus-like particle (HBcAg-VLP) by a C-terminal linker-hexahistidine-peptide . In: Journal of Nanobiotechnology . tape 16 , no. 1 , 2018, doi : 10.1186 / s12951-018-0363-0 , PMID 29653575 (English).

Small molecule immunomodulators

  • F. Vascotto, J. Petschenka, KC Walzer, M. Vormehr, M. Brkic, S. Strobl, R. Rösemann, M. Diken, S. Kreiter, Ö. Türeci, U. Sahin: Intravenous delivery of the toll-like receptor 7 agonist SC1 confers tumor control by inducing a CD8 + T cell response . In: Oncoimmunology . tape 8 , no. 7 , 2019, PMID 31143525 (English).

literature

Web links

Commons : Biontech  - Collection of Images
  • Company website
  • Portrait of the New York Times about BioNTech, Özlem Türeci and Uğur Şahin

Individual evidence

  1. ↑ a b c Biontech: Form 20-F , annual report for 2020 deposited with the SEC, accessed on May 11, 2021 (English, pdf)
  2. ↑ Mainz-based company Biontech tests corona vaccine. In: SWR aktuell. April 23, 2020, accessed November 12, 2020 .
  3. ↑ BioNTech CEO on vaccine progress with Pfizer - YouTube . Retrieved July 12, 2021.
  4. ↑ a b Our Vision. BioNTech SE, accessed on October 13, 2020 .
  5. ↑ a b c d e f g h i j k l BioNTech SE: Form F-1. US Securities and Exchange Commission , September 9, 2019, accessed September 23, 2020 .
  6. ^ Eva Müller, Lukas Heiny: "Lightspeed" project - this is how the search for BioNTech's vaccine went. In: Manager Magazin. November 9, 2020, accessed November 29, 2020 .
  7. ↑ Steffen Klusmann , Thomas Schulz: "We were asked why something big should come from Mainz" . In: Der Spiegel . No. 1 , 2021, p. 8-16 ( online ).
  8. ↑ Development of innovative vaccines against cancer. BMBF, November 12, 2020, accessed on March 10, 2021 .
  9. ↑ Jürgen Salz: Biontech investor Strüngmann: Der Pharma-David. In: WirtschaftsWoche. June 18, 2020, accessed November 11, 2020 .
  10. ↑ The bearer of hope behind the visions. May 6, 2020, accessed November 11, 2020 .
  11. ↑ Sebastian Balzter: Vaccination against Corona: "It will take a few years, I'm afraid". In: Frankfurter Allgemeine Zeitung . ISSN  0174-4909 ( faz.net [accessed November 11, 2020]).
  12. ↑ Eufets Becomes BioNTech Innovative Manufacturing Services. BioNTech IMFS, September 18, 2017, accessed November 11, 2020 .
  13. ↑ JPT Peptide Technologies publishes the Human Proteome Peptide Catalog. In: Pharmaceutical newspaper. April 10, 2018, accessed November 11, 2020 .
  14. ↑ Wista management: JPT peptides make the effects of a COVID-19 vaccine visible. April 24, 2020, accessed November 11, 2020 .
  15. ↑ Lena M. Kranz, Mustafa Diken, Heinrich Haas, Sebastian Kreiter, Carmen Loquai: Systemic RNA delivery to dendritic cells exploits antiviral defense for cancer immunotherapy . In: Nature . tape 534 , no. 7607 , June 16, 2016, ISSN  1476-4687 , p. 396-401 , doi : 10.1038 / nature18300 , PMID 27281205 ( nih.gov [accessed November 11, 2020]).
  16. ↑ Lena M. Kranz, Mustafa Diken, Heinrich Haas, Sebastian Kreiter, Carmen Loquai: Systemic RNA delivery to dendritic cells exploits antiviral defense for cancer immunotherapy . In: Nature . tape 534 , no. 7607 , June 2016, ISSN  1476-4687 , p. 396–401 , doi : 10.1038 / nature18300 ( nature.com [accessed November 11, 2020]).
  17. ↑ Pfizer uses Biontech for flu vaccines. In: transcript . Biocom , accessed November 11, 2020 .
  18. ↑ BioNTech enters into global strategic alliance with Genentech. In: GoingPublic. September 22, 2016, accessed November 11, 2020 .
  19. ↑ BioNTech SE. Nasdaq, accessed November 12, 2020 .
  20. ↑ Biontech: German IPO on the Nasdaq. ARD, accessed on November 11, 2020 .
  21. ↑ Ilka Kopplin: Biotechnology: Biontech earns less money than expected. In: Frankfurter Allgemeine Zeitung . October 10, 2019, ISSN  0174-4909 ( faz.net [accessed November 11, 2020]).
  22. ^ Siegfried Hofmann: Biotech: The IPO of Mainz Biontech disrupts the ranking of the German biotech industry. In: Handelsblatt. October 10, 2019, accessed November 11, 2020 .
  23. ↑ Biontech IPO is smaller - 20 percent lower volume - Mainz company starts on Nasdaq. In: Börsen-Zeitung . October 11, 2019, p. 12 .
  24. ↑ BioNTech specifies Nasdaq listing. In: Doctors newspaper. September 26, 2019, accessed November 12, 2020 .
  25. ↑ BioNTech announces further steps for the planned IPO. In: Wall Street Online. September 24, 2019, accessed November 12, 2020 .
  26. ↑ Biontech boss Sahin explains what will change as a result of the IPO. In: Handelsblatt. October 13, 2019, accessed November 27, 2020 .
  27. ↑ BioNTech buys MAB Discovery's antibody unit. In: BioM Cluster Development. Retrieved November 11, 2020 .
  28. ↑ BioNtech aquires antibody assets from MabVax Therapeutics. Biocom, May 9, 2019, accessed November 11, 2020 .
  29. ↑ Johannes Vetter: With double strength against the corona virus . In: Volksstimme . (Magdeburg). November 11, 2020 ( volksstimme.de [accessed November 11, 2020]).
  30. ↑ European Commission press release: Coronavirus: Commission approves contract with BioNTech-Pfizer alliance to ensure access to a potential vaccine. Brussels, 11 November 2020.
  31. ↑ BioNTech with COVID-19 news from China - shares slightly under pressure. In: 4investors. November 25, 2020, accessed November 26, 2020 .
  32. ↑ First study on corona vaccine in Germany starts. In: Hessenschau. April 22, 2020, accessed November 11, 2020 .
  33. ↑ Last analysis before approval confirms Biontech vaccine effectiveness of 95 percent. In: world. November 18, 2020, accessed November 27, 2020 .
  34. ↑ EMA receives application for conditional marketing authorization of COVID-19 mRNA vaccine BNT162b2. European Medicines Agency (EMA), December 1, 2020, accessed December 1, 2020 .
  35. ↑ Great Britain gives the green light for corona vaccine. In: Tagesschau. December 2, 2020, accessed December 2, 2020 .
  36. ↑ BioNTech receives BMBF funding of up to 375 million euros for COVID-19 vaccine program BNT162 , announcement from Biontech, September 15, 2020.
  37. ↑ This is how Biontech's vaccine success could be financially worthwhile , zdf.de , November 12, 2020.
  38. ↑ Corona vaccine: What happened to the federal funding? , zdf.de , February 17, 2021.
  39. ↑ a b EU Commission grants approval for first corona vaccination. Retrieved December 22, 2020 .
  40. ↑ a b c BioNTech SE: Form 20-F. US Securities and Exchange Commission , March 31, 2020, accessed November 10, 2020 .
  41. ↑ Deutsche Welle (www.dw.com): Balance day at the stock market star BioNTech | DW | 08/09/2021. Retrieved on August 10, 2021 (German).
  42. ↑ Fanny Jimenez: Biontech CEO Ugur Sahin about his corona vaccine: "We called our project 'Lightspeed' to make it clear: We don't waste any time." November 10, 2020, accessed on November 11, 2020 .
  43. ↑ Jan Siegrist: Coronavirus: This couple is behind the vaccine breakthrough. Nau Media, November 10, 2020, accessed on November 11, 2020 .
  44. ↑ a b Ingo Malcher: BioNTech: In the team against Corona . In: The time . June 3, 2020 ( zeit.de [accessed November 27, 2020]).
  45. ↑ Helen Albert: How BioNTech Navigates the Maze Biotech fundraising. December 18, 2019, accessed November 11, 2020 .
  46. ↑ Sierk Poetting, CFO, BioNTech SE. In: Topio Networks. Retrieved November 11, 2020 .
  47. ↑ Lastruperin is Corona hope: Biontech founder Türeci. NDR, accessed on November 11, 2020 .
  48. ↑ Finn Mayer-Kuckuk: Portrait of the Biontech bosses: The researcher couple . In: The daily newspaper (taz) . November 10, 2020, ISSN  0931-9085 ( taz.de [accessed November 11, 2020]).
  49. ↑ Biontech appoints Ryan Richardson to the board as Chief Strategy Officer. In: Labo. Retrieved November 11, 2020 .
  50. ↑ BioNTech appoints Jens Holstein to the board as Chief Financial Officer. Retrieved June 4, 2020 .
  51. ↑ a b management team. BioNTech SE, accessed on November 11, 2020 .
  52. ↑ Sebastian Balzter: Vaccination against Corona: "It will take a few years, I'm afraid". In: Frankfurter Allgemeine Zeitung . ISSN  0174-4909 ( faz.net [accessed November 11, 2020]).
  53. ↑ Andreas Geldner: Risk capital for biotechnology: It doesn't work without patience and idealism. In: Stuttgarter Zeitung. February 6, 2020, accessed November 11, 2020 .
  54. ↑ BioNTech Announces Corporate Form Transition from AG to SE; Welcomes Ryan Richardson as Senior Vice President Corporate Development and Strategy and Appoints Dr. Ulrich Wandschneider as Member of the Supervisory Board. In: Business Wire. January 4, 2019, accessed November 11, 2020 .
  55. ↑ Dr. Ulrich Wandschneider. Health Industry Congress 2019, accessed on November 11, 2020 .
  56. ↑ The initial public offering in the USA lifted BioNTech onto the international floor. MIG Fund, March 24, 2020, accessed November 12, 2020 .
  57. ↑ Target company of the MIG funds (here p. 20: BioNTech AG ). (PDF) Heiter Investment, accessed on November 12, 2020 .
  58. ↑ Christoph Huber: Pioneer of cancer research - personal details. In: Deutsches Ärzteblatt. July 7, 2014, accessed November 11, 2020 .
  59. ↑ Immunologist Christoph Huber awarded the Federal Cross of Merit. Mainz University Medical Center, accessed on November 11, 2020 .
  60. ↑ Stefan Stöcklin: RNA technology: corona vaccine at high speed. University of Zurich, March 26, 2020, accessed on November 11, 2020 .
  61. ↑ Manfred Lindinger: Peter Doherty on the eightieth: Deciphered immune defense . In: Frankfurter Allgemeine Zeitung . ISSN  0174-4909 ( faz.net [accessed November 11, 2020]).
  62. ↑ Hans Hengartner. In: Company House. Retrieved November 11, 2020 .
  63. ↑ Curriculum Vitae Professor Dr. Hans Hengartner. (PDF) Leopoldina - National Academy of Sciences, accessed on November 27, 2020 .
  64. ↑ IHK: Create planning security for Biontech. Günster: Keeping top research companies in Mainz. IHK Rheinhessen, accessed on November 12, 2020 .
  65. ↑ Development of the GFZ barracks: More space for Biontech? In: Allgemeine Zeitung Mainz. VRM, May 25, 2020, accessed on November 12, 2020 .
  66. ↑ BioNTech SE: BioNTech completes acquisition of Neon Therapeutics. In: Global News Wire. May 6, 2020, accessed November 11, 2020 .
  67. ↑ BioNTech takes over Neon to strengthen its global leadership position in T-cell therapies. In: finanzen.net. January 16, 2020, accessed November 10, 2020 .
  68. ↑ BioNTech takes over Neon to strengthen its global leadership position in T-cell therapies. In: finanznachrichten.de. BioNTech SE; Neon Therapeutics, Inc., accessed November 11, 2020 .
  69. ↑ Biontech buys cancer specialists in the USA. In: Der Spiegel. Retrieved July 19, 2021 .
  70. ↑ Novartis production site in Marburg goes to biotechnology company. Novartis Germany, September 17, 2020, accessed on November 11, 2020 .
  71. ↑ Biontech wants to take over Novartis vaccine production plant. In: Deutsche Apotheker Zeitung. September 18, 2020, accessed November 11, 2020 .
  72. ↑ Patrick Eickemeier: Biontech produces Covid-19 vaccine in Marburg. In: Der Tagesspiegel. September 17, 2020, accessed November 11, 2020 .
  73. ↑ Mainz-based company Biontech starts EU-wide delivery of corona vaccines. In: swr.de. December 22, 2020, accessed December 22, 2020 .
  74. ↑ Biontech is now allowed to manufacture its vaccine in Marburg
  75. ↑ Corona vaccine production in Marburg: Biontech receives approval under pharmaceutical law
  76. ↑ Coronavirus: Biontech takes over Novartis plant in Marburg for vaccine production. In: Der Spiegel. September 17, 2020, accessed September 18, 2020 .
  77. ↑ Biontech takes over 300 employees in Marburg. In: Gießener Anzeiger. September 20, 2020, accessed November 11, 2020 .
  78. ↑ EMA's human medicines committee: New manufacturing site and more flexible storage conditions for BioNTech / Pfizer's COVID-19 vaccine
  79. ↑ BioNTech provides Update on Vaccine Production Status at Marburg Manufacturing Site , company communication
  80. ^ History of the Institute for Experimental Therapy Marburg. Emil von Behring Library of the University of Marburg, Center for the History of Medicine, accessed on November 12, 2020 .
  81. ↑ BioNTech to Establish Regional Headquarters for Southeast Asia and First mRNA Manufacturing Facility in Singapore | BioNTech. May 10, 2021, accessed May 10, 2021 .
  82. ↑ a b BioNTech balance sheet income statement | Key figures | Sales | Profit. In: finanzen.net. Retrieved November 11, 2020 .
  83. ↑ Sascha Huber: BioNTech: US IPO is a little disappointing. In: sharedeals.de. Retrieved November 11, 2020 .
  84. ↑ https://www.rnd.de/wirtschaft/biontech-1-1-millionen-euro-gewinn-im-ersten-quartal-2021-STBKXC2WVRLRGQEYKWVVIEIZ6E.html Source: dpa message from May 10, 2021, accessed on May 13, 2021 May 2021.
  85. ↑ Katalin Karikó. In: 8th International mRNA Health Conference. Retrieved November 11, 2020 .
  86. ↑ Katalin Karikó. In: Topio Networks. Retrieved November 11, 2020 .
  87. ↑ Alexandra Kemmer-Brueck's research while affiliated with BioNTech AG and other places. In: ResearchGate. Accessed November 20, 2020 .
  88. ↑ Patricia Silva: BioNTech Collaborative Study Reveals a Potential New Strategy for Personalized Cancer Immunotherapy. In: Melanoma News Today. April 30, 2015, accessed November 11, 2020 .
  89. ↑ a b c U. Sahin, K. Karikó, Ö. Türeci: mRNA-based therapeutics - developing a new class of drugs . In: Nat Rev Drug Discov . tape 13 , no. 10 , 2014, p. 759-780 , doi : 10.1038 / nrd4278 , PMID 25233993 .
  90. ↑ a b U. Sahin, E. Derhovanessian, M. Miller, BP Kloke, P. Simon, M. Löwer, V. Bukur, AD Tadmor, U. Luxemburger, B. Schrörs, T. Omokoko, M. Vormehr, C Albrecht, A. Paruzynski, AN Kuhn, J. Buck, S. Heesch, KH Schreeb, F. Müller, I. Ortseifer, I. Vogler, E. Godehardt, S. Attig, R. Rae, A. Breitkreuz, C . Tolliver, M. Suchan, G. Martic, A. Hohberger, P. Sorn, J. Diekmann, J. Ciesla, O. Waksmann, AK Brück, M. Witt, M. Zillgen, A. Rothermel, B. Kasemann, D. Langer, S. Bolte, M. Diken, S. Kreiter, R. Nemecek, C. Gebhardt, S. Grabbe, C. Höller, J. Utikal, C. Huber, C. Loquai, Ö. Türeci: Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer . In: Nature . tape 547 , no. 7662 , 2017, p. 222-226 , doi : 10.1038 / nature23003 , PMID 28678784 .
  91. ↑ U. Sahin, Ö. Türeci: Personalized vaccines for cancer immunotherapy . In: Science . tape 359 , no. 6382 , 2018, p. 1355-1360 , doi : 10.1126 / science.aar7112 , PMID 29567706 .
  92. ^ S. Kreiter, A. Selmi, M. Diken, M. Koslowski, CM Britten, C. Huber, O. Tureci, U. Sahin: Intranodal vaccination with naked antigen-encoding RNA elicits potent prophylactic and therapeutic antitumoral immunity . In: Cancer Res . tape 70 , no. 22 , 2010, p. 9031-9040 , doi : 10.1158 / 0008-5472.CAN-10-0699 , PMID 21045153 .
  93. ↑ P. Simon, TA Omokoko, A. Breitkreuz, L. Hebich, S. Kreiter, S. Attig, A. Konur, CM Britten, C. Paret, K. Dhaene and others: Functional TCR retrieval from single antigen-specific human T. cells reveals multiple novel epitopes . In: Cancer Immunol Res . tape 2 , no. 12 , 2014, p. 1230-1244 , doi : 10.1158 / 2326-6066.CIR-14-0108 , PMID 25245536 .
  94. ↑ T. Omokoko, P. Simon, O. Tureci, U. Sahin: Retrieval of functional TCRs from single antigen-specific T cells: Toward individualized TCR-engineered therapies . In: Oncoimmunology . tape 4 , no. 7 , 2015, p. e1005523 , doi : 10.1080 / 2162402X.2015.1005523 , PMID 26140230 .
  95. ↑ Maike Telgheder: Biotech company: Corona pioneer Biontech researches many active ingredients against cancer. In: Handelsblatt. September 17, 2020, accessed November 11, 2020 .
  96. ↑ Biotech company BioNTech mainly develops immunotherapy for cancer treatment. In: Yahoo News. Retrieved November 11, 2020 .
  97. ↑ a b c Christiane R Stadler, Hayat Bähr-Mahmud, Laura M Plum, Kathrin Schmoldt, Anne C Kölsch, Özlem Türeci, Ugur Sahin: Characterization of the first-in-class T-cell-engaging bispecific single-chain antibody for targeted immunotherapy of solid tumors expressing the oncofetal protein claudin 6 . In: Oncoimmunology . tape 5 , no. 3 , 2015, p. e1091555 , doi : 10.1080 / 2162402X.2015.1091555 , PMID 27141353 .
  98. ↑ CP Sommerhoff, O. Avrutina, HU Schmoldt, D. Gabrijelcic-Geiger, U. Diederichsen, H. Kolmar: Engineered cystine knot miniproteins as potent inhibitors of human mast cell tryptase beta . In: J Mol Biol . tape 395 , no. 1 , 2010, p. 167-175 , doi : 10.1016 / j.jmb.2009.10.028 , PMID 19852971 .
  99. ↑ O. Avrutina, HU Schmoldt, D. Gabrijelcic-Geiger, A. Wentzel, H. Frauendorf, CP Sommerhoff, U. Diederichsen, H. Kolmar: Head-to-tail cyclized cystine-knot peptides by a combined recombinant and chemical route of synthesis . In: Chembiochem . tape 9 , no. 1 , 2008, p. 33-37 , doi : 10.1002 / cbic.200700452 , PMID 18058774 .
  100. ↑ S. Krause, HU Schmoldt, A. Wentzel, M. Ballmaier, K. Friedrich, H. Kolmar: Grafting of thrombopoietin-mimetic peptides into cystine knot miniproteins yields high-affinity thrombopoietin antagonists and agonists . In: FEBS J . tape 274 , no. 1 , 2007, p. 86-95 , doi : 10.1111 / j.1742-4658.2006.05567.x , PMID 17147697 .
  101. ↑ T. Klamp, J. Schumacher, G. Huber, C. Kuhne, U. Meissner, A. Selmi, T. Hiller, S. Kreiter, J. Markl, O. Tureci and others: Highly specific auto-antibodies against claudin- 18 isoform 2 induced by a chimeric HBcAg virus-like particle vaccine kill tumor cells and inhibit the growth of lung metastases . In: Cancer Res . tape 71 , no. 2 , 2011, p. 516-527 , doi : 10.1158 / 0008-5472.CAN-10-2292 , PMID 21224362 .
  102. ↑ CR Stadler, H. Bähr-Mahmud, L. Celik, B. Hebich, AS Roth, RP Roth, K. Karikó, Ö. Türeci, U. Sahin: Elimination of large tumors in mice by mRNA-encoded bispecific antibodies . In: Nat Med . tape 23 , no. 7 , 2017, p. 815-817 , doi : 10.1038 / nm.4356 , PMID 28604701 .
  103. ↑ BioNTech Acquires MabVax Therapeutics' Antibody Assets to Expand Portfolio. (PDF) BioNTech SE, May 9, 2019, accessed on November 21, 2020 .
  104. ↑ BioNTech receives BMBF funding of up to 375 million euros for COVID-19 vaccine program BNT162. BioNTech SE, September 15, 2020, accessed on November 11, 2020 .
  105. ↑ F. Vascotto, J. Petschenka, KC Walzer, M. Vormehr, M. Brkic, S. Strobl, R. Rösemann, M. Diken, S. Kreiter, Ö. Türeci, U. Sahin: Intravenous delivery of the toll-like receptor 7 agonist SC1 confers tumor control by inducing a CD8 + T cell response . In: Oncoimmunology . tape 8 , no. 7 , 2019, pp. 1601480 , doi : 10.1080 / 2162402X.2019.1601480 , PMID 31143525 .
  106. ↑ 4SC focuses on the clinical development of epigenetic substances and is selling the operational part of its Discovery division. Retrieved November 11, 2020 .
  107. ↑ M. Vormehr, M. Diken, S. Boegel, S. Kreiter, Ö. Türeci, U. Sahin: Mutanome directed cancer immunotherapy . In: Curr Opin Immunol . tape 39 , 2016, p. 14-22 , doi : 10.1016 / j.coi.2015.12.001 , PMID 26716729 .
  108. ^ MR Stratton, PJ Campbell, PA Futreal: The cancer genome . In: Nature . tape 458 , no. 7239 , 2009, p. 719-724 , doi : 10.1038 / nature07943 , PMID 19360079 .
  109. ^ MR Stratton: Exploring the genomes of cancer cells: progress and promise . In: Science . tape 331 , no. 6024 , 2011, p. 1553-1558 , doi : 10.1126 / science.1204040 , PMID 21436442 .
  110. ^ S. Kreiter, JC Castle, Ö. Türeci, U. Sahin: Targeting the tumor mutanome for personalized vaccination therapy . In: Oncoimmunology . tape 1 , no. 5 , 2012, p. 768-769 , doi : 10.4161 / onci.19727 , PMID 22934277 .
  111. ↑ Transfer initiative RLP | Technologies made in Rhineland-Palatinate | Who is Who | Sequencing & data analysis. (PDF) Retrieved November 22, 2020 .
  112. ↑ New therapeutic approach: Biontech develops individualized cancer drugs. In: Pharmaceutical newspaper. Retrieved November 11, 2020 .
  113. ↑ A bet on the future - biotech industry with only a few lighthouses. In: t3n.de. Retrieved November 11, 2020 .
  114. ↑ Marion Schlegel: German biotech vertical starter BioNTech not to be slowed down: “You can compare us with Tesla”. In: The shareholder. Retrieved November 11, 2020 .
  115. ↑ Thorsten Winter: Cancer and Infections: Novel Vaccines as a Target . In: Frankfurter Allgemeine Zeitung . ISSN  0174-4909 ( faz.net [accessed November 11, 2020]).
  116. ↑ The Gates Foundation sees BioNTech potential to 'dramatically reduce global HIV and tuberculosis'. September 5, 2019, accessed September 20, 2019 .
  117. ↑ BioNTech. The Gates Foundation, accessed November 11, 2020 .
  118. ↑ Pfizer and BioNTech to Co-develop Potential COVID-19 Vaccine. BioNTech SE, accessed on July 28, 2020 (English).
  119. ↑ BioNTech and Pfizer Announce Paul Ehrlich Institute Approval for First Clinical Trial of COVID-19 Vaccine Candidates. BioNTech SE, April 22, 2020, accessed on April 22, 2020 .
  120. ↑ BioNTech and Pfizer announce completion of dosing for first cohort of Phase 1/2 trial of COVID-19 vaccine candidates in Germany. BioNTech SE, April 29, 2020, accessed on April 29, 2020 (English).
  121. ↑ Corona: Biontech vaccine reaches 95 percent effectiveness . In: THE WORLD . November 18, 2020 ( welt.de [accessed December 1, 2020]).
  122. ↑ Science: Application for approval for corona vaccine submitted in the USA. In: The time . November 20, 2020, accessed December 1, 2020 .
  123. ↑ Vaccine: Biontech applies for conditional approval in the EU. Accessed December 1, 2020 .
  124. ↑ UK medicines regulator gives approval for first UK COVID-19 vaccine. Medicines and Healthcare products Regulatory Agency (MHRA), December 2, 2020, accessed on December 2, 2020 (English, press release).
  125. ↑ BioNTech and Genevant Sciences agree strategic partnership with mRNA focus for rare diseases. In: MarketScreener. Retrieved November 11, 2020 .
  126. ↑ Strategic partnership with mRNA focus for rare diseases. Retrieved November 11, 2020 .
  127. ↑ BioNTech publishes results for the entire 2019 financial year as well as information on business development. BioNTech SE, accessed on November 11, 2020 .
  128. ↑ BioNTech cooperation partner. Retrieved November 11, 2020 .
  129. ↑ BioNTech enters into cooperation with Genmab. In: GoingPublic. May 22, 2015, accessed November 11, 2020 .
  130. ↑ Freshfields Bruckhaus Deringer: BioNTech starts collaborations in cancer research. In: Legal Tribune Online. Retrieved November 11, 2020 .
  131. ↑ Cancer therapy: Freshfields and Honert advise BioNTech on deal with Eli Lilly. In: juve.de. www.juve.de, accessed on November 11, 2020 .
  132. ↑ Mainz: Biontech AG continues to grow rapidly - multi-million dollar cooperation with Pfizer. In: Allgemeine Zeitung Mainz. VRM, August 17, 2018, accessed November 11, 2020 .
  133. ↑ Siemens and BioNTech cooperate in the production of personalized cancer vaccines. In: apa.at. Retrieved November 11, 2020 .
  134. ↑ Siemens and Biontech agree on strategic cooperation. Retrieved November 11, 2020 .
  135. ↑ References | BioNTech. Siemens Global, accessed November 11, 2020 .
  136. ↑ Sanofi intensifies cooperation with BioNTech. Retrieved November 11, 2020 .
  137. ↑ Sanofi invests in Biontech: Another pharmaceutical giant joins the German biotech star. In: Handelsblatt. Retrieved November 11, 2020 .
  138. ↑ Biontech chooses Bayer as a partner. In: transcript. Biocom, accessed November 11, 2020 .
  139. ↑ Veterinary medicine: Bayer and BioNTech develop vaccines and therapeutics. In: CHEManager. Retrieved November 11, 2020 .
  140. ↑ High Tech Corporate Services GmbH - News: BioNTech enters into global strategic collaboration with Genentech to develop individualized mRNA cancer therapies . Retrieved November 11, 2020 .
  141. ↑ Armin Huber: BioNTech and Genentech cooperate. In: Finanzwelt. September 27, 2016, accessed November 11, 2020 .
  142. ↑ BioNTech and Genevant Sciences agree strategic partnership with mRNA focus for rare diseases. Retrieved November 11, 2020 .
  143. ↑ Freshfields advises BioNTech on partnership with Genevant Sciences. Retrieved November 11, 2020 .
  144. ↑ Pfizer and BioNTech develop vaccine candidates against COVID-19. Retrieved November 11, 2020 .
  145. ↑ Pfizer Inc. and MIG Fonds portfolio company BioNTech are considering expanding the research collaboration for corona vaccine. In: PresseBox. Retrieved November 11, 2020 (press release).
  146. ↑ Markus Schug: Million Dollar Funding: Money from Bill Gates for Mainz researchers . In: Frankfurter Allgemeine Zeitung . ISSN  0174-4909 ( faz.net [accessed November 11, 2020]).
  147. ↑ "The Germany-USA combination is exactly the right one for Biontech". January 21, 2020, accessed November 11, 2020 .
  148. ↑ Gates Foundation is investing around 50 million euros in BioNtech, a Mainz-based company. November 11, 2020, accessed November 11, 2020 .
  149. ↑ BioNTech and InstaDeep announce strategic partnership and found AI Innovation Lab to develop new immunotherapies. In: boerse.de. November 25, 2020, accessed November 27, 2020 .
  150. ↑ The TRON congratulates its cooperation partner BioNTech SE on the successful IPO. TRON Translational Oncology Mainz, accessed on November 11, 2020 .
  151. ↑ First example of a clinically applicable and systemic mRNA vaccine for cancer immunotherapy presented. Retrieved November 11, 2020 .
  152. ↑ Ci3: BioNTech enters into global strategic collaboration with Genentech to develop individualized mRNA cancer therapies (October 13, 2016). Federal Ministry of Education and Research, accessed on November 11, 2020 .
  153. ^ Topping- out ceremony for the Biotech Campus Mainz. Retrieved November 11, 2020 .
  154. ↑ Leading-edge cluster Ci3 with personalized cancer vaccines leading across Europe | CHEManager. Retrieved November 11, 2020 .
  155. ↑ Cooperations | BioNTech. German Center for Infection Research, accessed on November 11, 2020 .
  156. ↑ Coronavirus: This is the state of vaccine development. Federal Ministry of Education and Research (BMBF), accessed on November 11, 2020 .
  157. ^ Tumor Neoantigen Selection Alliance (TESLA). In: Parker Institute for Cancer Immunotherapy. Retrieved November 11, 2020 (American English).
  158. ↑ Biontech becomes part of TESLA. In: transcript. Biocom, accessed November 11, 2020 .
  159. ↑ Siegfried Hoffmann: Biotechnology: Biontech wants to expand further with vaccines against infectious diseases. In: Handelsblatt. Retrieved November 11, 2020 .
  160. ↑ BioNTech registers IPO on Nasdaq. In: Doctors newspaper. September 12, 2019, accessed November 11, 2020 .
  161. ↑ Will Biontech give way to China? Taiwan's president is making allegations. In: Business Insider Germany. June 1, 2021, accessed on June 16, 2021 (German).
  162. ↑ Matthias Sander: Taiwan is not making good progress with vaccination. China should be to blame. Neue Zürcher Zeitung, June 2, 2021, accessed on June 16, 2021 .
  163. ↑ Friederike Böge: Taipei is annoyed: Has BioNTech pushed Taiwan to give up self-designation as a country? In: FAZ.NET . ISSN  0174-4909 ( faz.net [accessed June 16, 2021]).
  164. ^ Maximilian Kalkhof: Between China and Taiwan. Why Germany is getting involved in a vaccine dispute. In: T-Online.de. June 3, 2021, accessed June 16, 2021 .
  165. ↑ Intellectual Property. BioNTech SE, accessed on November 11, 2020 .
  166. ↑ BioNTech Patents. In: CB Insights. Accessed November 12, 2020 .
  167. ↑ Patents Assigned to BioNTech. In: Justia Patents Search. Retrieved November 12, 2020 .
  168. ↑ BioNTech: How does the mRNA vaccine candidate work? In: patent-anmelden.net. October 23, 2020, accessed November 11, 2020 .
  169. ↑ Jacek Jemielity, Joanna Kowalska, Edward Darzynkiewicz and team (Poland). European Patent Office (EPO), accessed November 12, 2020 .
  170. ↑ Polski patent zarobił już 610 mln euro, ale ... dla firmy z Niemiec. Pozbyliśmy się kury znoszącej złote jajka? In: wyborcza.pl. Retrieved November 12, 2020 (Polish).
  171. ↑ Cecilia Martin, Drew Lowery: mRNA vaccines: intellectual property landscape . In: Nature Reviews Drug Discovery . tape 19 , no. 9 , July 27, 2020, p. 578-578 , doi : 10.1038 / d41573-020-00119-8 ( nature.com [accessed November 12, 2020]).
  172. ↑ Book about Biontech founding couple appears. In: ORF at. August 23, 2021, accessed on August 30, 2021 .