BioNTech

BioNTech SE, a biotechnology company, develops and commercializes immunotherapies for cancer and other infectious diseases. The company is developing FixVac product candidates, including BNT111, which is in Phase II clinical trial for advanced melanoma; BNT112 which is in Phase I/IIa clinical trial for prostate cancer; BNT113, which is in Phase II clinical trial to treat HPV+ head and neck cancers; BNT114 that is in Phase I clinical trial for triple-negative breast cancer; BNT115, which is in Phase I clinical trial in ovarian cancer; and BNT116, a preclinical stage product for non-small cell lung cancer. 

It also develops neoantigen-specific immunotherapies, such as Autogene cevumeran (BNT122), which is in Phase II clinical trial for first-line melanoma, as well as in Phase 1a/1b clinical trial to treat multiple solid tumours; mRNA intratumoral immunotherapy comprising SAR441000 that is in Phase I clinical trial for solid tumours; and BNT141 and BNT142 that are in Phase I clinical trial to treat multiple solid tumours. In addition, the company develops RiboCytokines, which include BNT151, BNT152, and BNT153 to treat solid tumours; chimeric antigen receptor T cell immunotherapies, such as BNT211 to treat multiple solid tumours, and BNT221 for other cancers; and checkpoint immunomodulators consisting of GEN1046 and GEN1042, which are in Phase I/II clinical trial to treat solid tumours. 

Further, it develops BNT321, an IgG1 monoclonal antibody in Phase II clinical trial for pancreatic cancer; BNT411, a small molecule immunomodulator product candidate for solid tumours; prophylactic vaccine for COVID-19 and Influenza; an infectious disease immunotherapies and rare disease protein replacement therapies. The company has collaborations with Genentech, Inc.; Sanofi S.A.; Genmab A/S; Pfizer Inc.; Shanghai Fosun Pharmaceutical (Group) Co., Ltd.; and Regeneron Pharmaceuticals, Inc. BioNTech SE was incorporated in 2008 and is headquartered in Mainz, Germany.

BioNTech was founded in 2008 based on research by Ugur Sahin, Özlem Türeci, and Christoph Huber, with a seed investment of €150 million. The company's activities focus on the development and production of technologies and drugs for individualized cancer immunotherapy. Andreas and Thomas Strüngmann, Michael Motschmann, and Helmut Jeggle were cofounders. 

In 2009, the acquisition of EUFETS and JPT Peptide Technologies took place. Katalin Karikó, whose work on mRNA whilst working at the University of Pennsylvania underpinned the development of Pfizer–BioNTech COVID-19 vaccine, joined BioNTech as a senior vice president in 2013.

Between 2014 and 2018, many research results on mRNA mechanisms were published by BioNTech. Collaborations and commercialization programs were concluded with various companies and scientific institutions starting in 2015. During this period, BioNTech filed several patent applications and developed a multi-layered strategy to protect its intellectual property in the various technology platforms and their application in the treatment of cancer and other serious diseases.

In August 2018, the company entered into a multi-year research and development collaboration with the US company Pfizer Inc. to develop mRNA-based vaccines for the 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. In January 2019, Sanofi invested €80 million in BioNTech and extended the mRNA cancer research collaboration between the two companies; Sanofi previously paid US$60 million upfront for the rights to five discovery-stage immunotherapies of BioNTech in 2015. In September 2019, BioNTech received a capital contribution of US$55 million from the Bill & Melinda Gates Foundation, with the option of doubling that investment amount at a later date.

Since 10 October 2019, BioNTech, with its newly founded North American headquarters in Cambridge, Massachusetts, has been publicly traded as American Depository Shares on the NASDAQ Global Select Market under the ticker symbol, BNTX. BioNTech was able to generate total gross proceeds of 150 million dollars from the IPO. In 2021, BioNTech announced it would open its Asia headquarters in Singapore, and also open a vaccine manufacturing plant there, with support from the Singapore Economic Development Board. The Singapore factory is expected to be operational by 2023 and produce hundreds of millions of doses of mRNA vaccines per year. A collaboration with Fosun Pharma is planned to add a facility in China to produce a billion doses per year for China, Macau, Hong Kong, and Taiwan, though as of August 2021, the PRC had not approved any foreign-developed COVID-19 vaccines.

“We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases.”

“BioNTech works closely with some of the world’s most established pharmaceutical companies and non-profit organizations to drive breakthroughs in medical science, therapeutical innovations, and improvement of quality of care.”