Translate Bio and Sanofi Ink Potential $850 Million mRNA Vaccine Development Deal

Translate Bio, headquartered in Lexington, Massachusetts, and Paris-based Sanofi are teaming up to develop five vaccines.

Translate Bio, headquartered in Lexington, Massachusetts, and Paris-based Sanofi are teaming up to develop five vaccines.

The two companies announced a multi-year research-and-development collaboration and an exclusive licensing deal to develop mRNA vaccines for up to five infectious diseases, which at this time have not been disclosed. Under the terms of the deal, the two companies will conduct R&D activities jointly as part of an initial three-year research period. Sanofi Pasteur will pay Translate Bio $45 million upfront. Translate Bio will be eligible for up to $805 million in milestone payments across the various vaccine targets. It is also eligible for tiered royalty payments.

“Sanofi Pasteur is pursuing a variety of emerging technologies that will allow us to continue to lead in research and development of next-generation vaccines,” said John Shiver, senior vice president, R&D, for Sanofi Pasteur, in a statement. “We believe mRNA technology has significant potential for rapid and versatile manufacturing, reduced industrialization costs for multiple vaccines, and the improved breadth of immune response for infectious disease vaccines. The Translate Bio platform may allow us to further address medical needs worldwide, including those not readily accessible using conventional vaccine strategies.”

A typical vaccine works by using specific proteins expressed on the surface of the virus to stimulate the human immune system to attack those viruses. mRNA vaccines, the companies say, “offer an innovative approach by delivering the nucleotide sequence encoding any protein associated with prevention or treatment of a pathogen. Because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration, mRNA vaccines represent a potentially innovative alternative to conventional vaccine approaches.”

Translate Bio recently filed with the U.S. Securities and Exchange Commission (SEC) for an IPO of $115 million. It expects to list on the Nasdaq under the TBIO ticker symbol. On April 12, the U.S. Food and Drug Administration (FDA) gave the company the go-ahead to launch a first-in-human clinical trial of MRT5005 in patients with cystic fibrosis. MRT5005 is an mRNA product candidate designed to treat the underlying cause of CF. It is designed to deliver mRNA that encodes fully functional CF transmembrane conductance regulator (CFTR) protein to the lung epithelial cells via nebulization.

Infectious disease isn’t really Translate Bio’s primary focus, that’s the CF treatment, as well as MRT5201, which targets a rare liver disease. That drug is expected to begin clinical trials at the beginning of next year.

Xconomy notes, “There has been no shortage of hype surrounding mRNA medicines, and that’s in part because of the fundraising success of Moderna. While privately held and without much human clinical data, Moderna has secured more than $1.6 billion in venture financings, another $1 billion in partnerships, and has a valuation north of $7 billion. Moderna has had some stops and starts in terms of its clinical strategy, but the company has chosen to put the bulk of its initial work into experimental vaccines for cancer and infections like Zika, chikungunya virus, cytomegalovirus.”

Nor is this Sanofi’s first partnership deal for mRNA vaccines. In 2015 it paid BioNTech $60 million to co-develop mRNA cancer vaccines.