Pfizer, Biotech Partner on RNA Flu Vaccine

3-D print of influenza virus (National Institute of Allergy and Infectious Diseases, NIH)

16 August 2018. A biotechnology company in Germany and drug maker Pfizer are developing a vaccine to prevent seasonal influenza using messenger RNA that instructs cells on production of proteins. The collaboration could bring BioNTech AG in Mainz as much as $425 million if all aspects of the agreement are completed.

BioNTech is a 10-year old company spun off from Johannes-Gutenberg University in Mainz developing immunotherapies from synthetic forms of messenger RNA, a nucleic acid related to DNA transmitted to cells for production of amino acids in proteins to carry out functions in the body. Much of the company’s current pipeline is devoted to cancer treatments that go beyond messenger RNA immunotherapies to protein and small molecule drugs, and cell and gene therapies, including chimeric antigen receptor, or CAR T-cell treatments for cancer. BioNTech also has a diagnostic division and manufacturing facilities.

In the new partnership, BioNTech and Pfizer will collaborate on development of vaccines to prevent influenza based on messenger RNA. BioNTech will be responsible for the first clinical trial of the vaccine, followed by Pfizer’s further clinical development and commercialization. Pfizer is making an initial payment of $120 million that includes early research work on the vaccine and an undisclosed equity stake in BioNTech. In addition, BioNTech is eligible for future development, regulatory, and commercialization milestone payments totaling $305 million, as well as royalty payments on sales of products from the partnership.

Pfizer has a vaccines division with products in clinical trials to prevent a range of infections including hospital-acquired Staphylococcus aureus and clostridium difficile infections. The company is also developing vaccines to prevent infections from some types of streptococcus, pneumococcal, and meningococcal bacteria, as well as respiratory syncytial viruses. The deal with BioNtech appears to be the company’s only current vaccine addressing influenza.

Pfizer indicates BioNTech’s messenger RNA, or mRNA, technology offers a way to develop and produce seasonal flu vaccines more quickly, which now must be planned months in advance. “Innovative vaccine approaches are urgently needed to provide improved protection against seasonal flu, and to respond rapidly and in quantity to pandemic influenza threats,” says Kathrin Jansen, who heads Pfizer’s vaccine R&D unit, in a BioNTech statement. “mRNA vaccines offer a novel approach to code for any protein or multiple proteins, and the potential to manufacture higher potency flu vaccines more rapidly and at a lower cost than contemporary flu vaccines.”

Likewise, BioNTech has no other product or collaboration underway for human infectious diseases. In May 2016, the company announced a partnership with drug maker Bayer to develop undisclosed messenger RNA therapies and vaccines for animals, which may also cover infectious diseases.

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Disclosure: The author owns shares in Pfizer.

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