Press Release

Mainz, Germany, January 04, 2019 – BioNTech AG, a rapidly growing biotechnology company developing precise and individualized immunotherapies for the treatment of cancer and the prevention of infectious diseases, today announced that it has extended its research collaboration with Sanofi initiated in late 2015 and Sanofi is investing^* EUR 80 million (approximately USD 91.5 million) in equity in BioNTech.

Simultaneously BioNTech has entered into an agreement with Sanofi to co-develop the first cancer immunotherapy candidate from the collaboration that is entering clinical testing in multiple solid tumors. This follows BioNTech’s decision from early 2018 to exercise one of its option rights under the 2015 research collaboration to co-develop and co-commercialize this product candidate with Sanofi.

 The investigational therapy consists of an mRNA mixture encoding immunomodulatory cytokines that are injected directly into the tumor. Local administration of immunotherapies to the tumor microenvironment provides the opportunity to stimulate innate and adaptive immune responses against tumors, while potentially avoiding toxicities related to systemic administration of immuno-modulatory therapeutics.

“The extension of the research collaboration and equity investment demonstrates a deepening of our partnership with Sanofi as we seek to rapidly drive novel, disruptive programs through clinical testing to commercialization together,” said Prof. Dr. Ugur Sahin, Co-Founder and CEO of BioNTech. “We are pleased that with this program we have moved from concept to clinical stage in well under three years.”

“We are pleased to be initiating clinical testing of our first mRNA-based cancer immunotherapy in collaboration with our partners at BioNTech,” commented Yong-Jun Liu, Global Head of Research, Senior Vice President R&D, Sanofi. “Our joint team, consisting of scientists and clinicians from both Sanofi and BioNTech, has worked tirelessly to expedite development of this new and innovative clinical candidate because targeted mRNA therapies may have the potential to be effective for cancer patients. We look forward to continuing a productive partnership with BioNTech in the years to come.”

^* Subject to completion of issuance of shares

 About BioNTech

BioNTech is Europe’s largest privately-held biopharmaceutical company pioneering the development of more precise and individualized therapies for cancer and the prevention of infectious diseases. The company combines all building blocks for more precise and individualized immunotherapies under one roof – from diagnostics and drug development to manufacturing. Its cutting-edge technologies range from individualized mRNA-based product candidates through innovative chimeric antigen receptors and T-cell receptor-based compounds to novel checkpoint immunomodulators and small molecules. BioNTech’s commercial approach is validated by seven corporate partnerships with Genentech, a member of the Roche Group, Pfizer, Genmab, Eli Lilly and Company, Sanofi, Genevant and Bayer Animal Health and its scientific approach through over 60 peer-reviewed scientific publications, including five publications in Nature. Founded in 2008, BioNTech’s financial shareholders include the Struengmann Family Office as its majority shareholder, Fidelity Management & Research Company, Invus, Janus Henderson Investors, MIG Fonds, Redmile Group, Salvia and several European family offices. For more information, please see:  www.biontech.de