BioNTech Inks $425 Million Collaboration Deal with Pfizer to Develop mRNA-based Flu Vaccines
BioNTech, headquartered in Mainz, Germany, and Pfizer, based in New York City, signed a multi-year research-and-development deal to develop mRNA-based flu vaccines.
Under the terms of the deal, the two companies will jointly conduct R&D activities to advance mRNA-based flu vaccines. Pfizer will take over sole responsibility for clinical development and commercialization after BioNTech wraps its first in-human clinical trial.
Pfizer will pay BioNTech $120 million in upfront, equity and near-term research payments. There will be up to $305 million in potential developmental, regulatory and commercial milestone payments. BioNTech is also eligible for up to double-digit tiered royalty payments on worldwide sales of any products that come out of the collaboration.
“Today’s agreement with Pfizer is one of a number of steps that we are taking to rapidly build a sustainable R&D presence in infectious disease, combining our deep understanding of the immune system to treat disease with the cutting-edge technologies and significant infrastructure that we have built up over many years to develop immunotherapy treatments,” said Ugur Sahin, BioNTech’s co-founder and chief executive officer, in a statement. “A significant presence in infectious disease supports our goal of building a global immunotherapy company that provides more effective and precise immuno-mediated approaches for the prevention and treatment of serious illnesses, such as the prevention of flu and the treatment of cancer.”
As Sahin says, the company’s primary focus has been on immuno-oncology, so infectious diseases are something of a departure. However, mRNA is of a great deal of interest in vaccine development, because it can be used to code for “any protein or multiple proteins, and the potential to manufacture high potency flu vaccines more rapidly and at a lower cost than contemporary flu vaccines,” said Katrin Jansen, senior vice president and head of Pfizer’s Vaccine Research and Development Unit, in a statement.
PMLive notes, “mRNA vaccines have long been held up as a promising alternative to conventional vaccines, but until lately progress has been held back by difficulties associated with delivering them efficiently and in stable form into the body. Technological improvements have improved the delivery of mRNA and its ability to translate proteins in vivo, and potent immune responses have been achieved using the approach in animal models of a number of diseases, including Zika and rabies.”
Cambridge, Mass.-based Moderna Therapeutics, for example, focuses on mRNA technologies with much of its pipeline dedicated to vaccines for infectious diseases or cancer. Its infectious disease pipeline includes clinical trials for CMV, HMPV/PIV3, Influenza H10 and H7, Zika and Chikungunya.
Other companies focused on mRNA include Belgium’s eTheRNA and U.S.-based CureVac. BioNTech already has partnerships with Roche’s Genentech, Eli Lilly, Sanofi, Genmab and Bayer Animal Health.
Although it’s a yearly occurrence, last year’s flu outbreak, according to the Centers for Disease Control and Prevention (CDC), was the worst in the U.S. since 2003-2004. This emphasizes the need for effective flu vaccines, and some of the focus is on new approaches such as mRNA vaccines, to create high potency vaccines more quickly and cheaply.