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BioNTech

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BioNTech SE
Company typePublic
Nasdaq: BNTX
ISINUS09075V1026
IndustryBiotechnology
Founded2008; 16 years ago (2008)
Founders
Headquarters
Mainz
,
Germany
Number of locations
17 (2024[1])
Area served
Worldwide
Key people
ProductsPfizer-BioNTech COVID-19 vaccine, Immunotherapy and vaccine candidates
ServicesImmunotherapy
RevenueDecrease €3.819 billion (2023)
Decrease €690.4 million (2023)
Decrease €930.3 million (2023)
Total assetsDecrease €23.01 billion (2023)
Total equityIncrease €20.25 billion (2023)
Number of employees
Increase 6,133 (2023)
Websitebiontech.com
Footnotes / references
BioNTech FY 2023 report[2]

BioNTech SE (/biːˈɒntɛk/ bee-ON-tek; or /baɪˈɒntɛk/ bye-ON-tek[3] short for Biopharmaceutical New Technologies) is a global biotechnology company headquartered in Mainz that develops immunotherapies and vaccines, particularly for cancer and infectious diseases.

The company utilizes technology platforms including mRNA-based therapies, targeted therapies, and immunomodulators, to develop its treatments. BioNTech's pipeline includes several late-stage programs in oncology[4][5] testing combination therapy approaches to improve treatment outcomes.

In the field of infectious diseases, BioNTech, partnering with Pfizer, developed Comirnaty, the first approved mRNA-based vaccine, which was widely used during the COVID-19 pandemic.[6][7]

History

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Foundation (2008–2014)

[edit]

BioNTech was founded in 2008 based on research by Uğur Şahin, Özlem Türeci,[8] and Christoph Huber,[9] with a seed investment of €180 million[10] from MIG Capital, a Munich-based venture capital firm, the family office of Andreas and Thomas Strüngmann, and the present chairman of the supervisory board, Helmut Jeggle.[11][12][13] In 2009, the acquisition of EUFETS and JPT Peptide Technologies took place.[14][15]

The company's origins lie in research conducted by Şahin, Türeci, and their teams, who over several decades made progress in addressing challenges using messenger RNA (mRNA) as a therapeutic. Their aim was to utilize mRNA for the development of individualized cancer immunotherapies. They focused on overcoming issues such as mRNA's limited stability in the body, developing formulations to effectively deliver mRNA to target cells, and improving protein production, which was initially low and short-lived.[16][4] In 2013, Hungarian biochemist Katalin Karikó, who later shared the 2023 Nobel Prize in Physiology or Medicine,[17] joined BioNTech as a senior vice president. She later stayed an external advisor.[18] Karikó discovered that modifying the nucleotide uridine could reduce the immunogenicity of mRNA, making it more suitable for therapeutic use.[19] All of these scientific discoveries were utilized in BioNTech's mRNA-based drug development.[18]

Expansion, Series A financing (2015–2018)

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Between 2014 and 2018, research results on mRNA mechanisms were published by BioNTech.[20] Collaborations and commercialization agreements were concluded with various companies and scientific institutions starting in 2015.[21] In January 2018, BioNTech closed a US$270 million Series A financing round to further expand the company's immunotherapy research.[22]

In August 2018, the company entered into a multi-year research and development (R&D) collaboration with the US company Pfizer, Inc. to develop mRNA-based vaccines for prevention of influenza. Under the terms of the agreement, following BioNTech's completion of a first-in-human clinical study, Pfizer would assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines.[23]

Series B financing and Nasdaq IPO (2019)

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In July 2019, Fidelity Management & Research Company led a Series B investment round totalling US$225.6 million, with investments from new and existing investors, including Redmile Group, Invus, Mirae Asset Financial Group, Platinum Asset Management, Jebsen Capital, Steam Athena Capital, BVCF Management and the Strüngmann family office.[24][25] In September 2019, BioNTech received a contribution of US$55 million from the Bill & Melinda Gates Foundation.[26] In December 2019, BioNTech received a €50 million loan to finance the development of its patient-specific immunotherapies for the treatment of cancer and other serious diseases, from the European Investment Bank (EIB) as part of the European Commission Investment Plan for Europe.[27]

Since 10 October 2019, BioNTech has been publicly traded as American Depository Shares (ADS) on the NASDAQ Global Select Market under the ticker symbol BNTX.[28] BioNTech was able to generate total gross proceeds of US$150 million from the IPO.[29]

COVID-19 (since 2020)

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See also: Pfizer–BioNTech COVID-19 vaccine and COVID-19 vaccine § Clinical trials started in 2020

BioNTech initiated "Project Lightspeed" in January 2020 to develop an mRNA-based COVID-19 vaccine, just days after the SARS-Cov-2 genetic sequence was first made public.[30] In March 2020, BioNTech partnered with Fosun Pharma for mainland China and the special administrative regions of Hong Kong and Macau and Pfizer for the rest of the world, excluding Germany and Turkey, where BioNTech retained exclusive rights.[31] Clinical trials began in April 2020 across multiple regions.[32]

Due to the global situation caused by the pandemic and the need for a vaccine, BioNTech received financial support from the European Investment Bank (a €100 million loan in June 2020)[33][34][35][36] and the German Federal Ministry of Education and Research (a €375 million grant).[37] BioNTech also received €250 million from Temasek Holdings (Singapore) in June 2020 via the purchase of ordinary shares and 4 years convertible notes, but also from other investors through a private placement of mandatory convertible bonds.[38]

In November 2020, BioNTech and it's partner Pfizer announced the vaccine's 95% efficacy, and by December, it received emergency use authorizations in the United Kingdom[39][40] and the United States,[41] followed by conditional marketing approval in the European Union.[42] After those steps, the large-scale vaccinations began. In August 2021, thanks to a meteoric rise in its share price, BioNTech’s market capitalization briefly exceeded US$100 billion, making it one of the most valuable companies in Germany at that time.[43]

Oncology and international expansion (since 2021)

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Alongside ongoing development of COVID-19 vaccines, BioNTech expanded its oncology pipeline and drug manufacturing capabilities,[44][44][45] leading to an increasing number of trials in advanced clinical phases.[45][46][47][48]

The company has formed strategic collaborations and acquisitions to enhance its platform technologies, global manufacturing capacity, and computational drug discovery capabilities.[49][50] In 2023, BioNTech acquired InstaDeep, a british AI technology company, to strenthen its AI-driven approach in drug development. BioNTech had been collaborating with InstaDeep since 2019 on cancer drug design and expanded their partnership in 2022 to create an early warning system for detecting SARS-CoV-2 variants of concern.[51][52]

In February 2022, BioNTech introduced the BioNTainer, a modular system for decentralized and scalable production of mRNA-based medicines in various locations. The first BioNTainer-based manufacturing site was inaugurated in Kigali, Rwanda, in December 2023, marking BioNTech's first facility in Africa.[53] That same month, BioNTech announced a partnership with the Australian state of Victoria to build a BioNTainer-based clinical-scale mRNA manufacturing plant in Melbourne.[54]

In 2023, BioNTech entered a collaboration with the UK government to expand access to personalized mRNA cancer immunotherapies in clincial trials, aiming to treat up to 10,000 patients by 2030.[55][56]

Company structure

[edit]

Locations

[edit]
BioNTech is located in Germany
Mainz
Mainz
Idar-Oberstein
Idar-Oberstein
Munich
Munich
Berlin
Berlin
Marburg
Marburg
Halle an der Saale
Halle an der Saale
class=notpageimage|
Locations of BioNTech in Germany.

BioNTech's founding place and global headquarters is Mainz, Germany.[57] Other sites in Germany are located in Berlin, Halle (Saale), Idar-Oberstein, Marburg, and Munich. The company operates several GMP-certified manufacturing sites across Germany.[58][59][60]

BioNTech also operates international offices and manufacturing sites in Europe (Vienna, Austria; London, England; Cambridge, England),[61] North America (Berkeley Heights, U.S.; Cambridge, U.S.; Gaithersburg, U.S.),[62] Asia (Istanbul, Turkey; Singapore;[63][64] Shanghai, China), Australia (Melbourne)[65] and Africa (Kigali, Rwanda).[66][67]

Management Board

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The management Board of BioNTech, as of July 2024, is made up of Uğur Şahin (Chief Executive Officer), Annemarie Hanekamp (Chief Commercial Officer), Jens Holstein (Chief Financial Officer), Sierk Poetting (Chief Operating officer), Ryan Richardson (Chief Strategy Officer), James Ryan (Chief Legal and Chief Business Officer) and Özlem Türeci (Chief Medical Officer).[68]

Therapeutic areas

[edit]

Oncology

[edit]

To enhance cancer treatment, BioNTech is developing combinations of multiplatform assets, including targeted therapies, immunomodulators, and mRNA-based therapies, with the aim of creating synergistic effects. By identifying novel cancer-specific or tumor-specific targets and integrating its platforms, BioNTech seeks to improve treatment outcomes across all stages of cancer.[69][4] For example, the company is developing combination therapies, such as pairing CAR-T cell treatments with mRNA-based vaccines. These vaccines encode target structures that boost CAR-T cell activity and persistence, enhancing the overall treatment effectiveness.[47][70][46]

In November 2023, in an interview to German broadcaster ZDF, BioNTech CEO Uğur Şahin said the company expects a mRNA-based therapeutic cancer vaccine approval by 2030.[71] BioNTech also announced in May 2024 that it expects to launch its first cancer therapies starting in 2026.[72]

Infectious diseases

[edit]
Pfizer–BioNTech COVID-19 vaccine

BioNTech is developing mRNA-based vaccines for a range of infectious diseases with significant global health impact, including COVID-19, malaria, tuberculosis, and mpox.[53][73]

See also

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References

[edit]
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  2. ^ "BioNTech 2023 Annual Report (Form 20-F)". U.S. Securities and Exchange Commission. 20 March 2024. Retrieved 24 June 2023.
  3. ^ "BioNTech CEO on vaccine progress with Pfizer – YouTube". Retrieved 14 June 2021 – via YouTube.
  4. ^ a b c BioNTech SE (9 September 2019), "Form F-1", U.S. Securities and Exchange Commission, archived from the original on 14 February 2021, retrieved 23 September 2020
  5. ^ Amy Baxter (14 August 2024). "Can BioNTech sustain a post-COVID mRNA pipeline? Oncology is the next hope". PharmaVoice. Retrieved 15 December 2024.
  6. ^ "Covid-19: Studies Indicate Pfizer-BioNTech Vaccine Protects Against the Most Severe Outcomes of Some Virus Variants". The New York Times. 5 May 2021. Retrieved 14 December 2024.
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  72. ^ "BioNTech will 2026 Krebsmedikament auf Markt bringen". Tagesschau (in German). 20 March 2020. Retrieved 26 November 2023.
  73. ^ Thorsten Winter (6 November 2018). "Krebs und Infektionen: Neuartige Impfstoffe als Ziel". Frankfurter Allgemeine Zeitung. Retrieved 14 December 2024.
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49°59′16″N 8°16′17″E / 49.9878°N 8.2713°E / 49.9878; 8.2713

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