Sanofi’s global vaccines unit Sanofi Pasteur will partner with Translate Bio to develop mRNA vaccines for up to five undisclosed infectious disease pathogens, through a collaboration that the mRNA therapeutics developer said today could generate for it up to $805 million-plus.
During the collaboration’s initial three-year research term, Translate Bio said, it will join Sanofi Pasteur in jointly conducting R&D activities to advance mRNA vaccines. Sanofi Pasteur agreed to pay for all costs during the research term and receive exclusive worldwide commercialization rights.
In return, Sanofi Pasteur agreed to pay Translate Bio $45 million upfront, and up to $760 million in payments tied to achieving development, regulatory, and sales-related milestones across several vaccine targets, as well as option exercise fees if Sanofi Pasteur exercises its option related to development of vaccines for additional pathogens.
Translate Bio said it is also eligible to receive tiered royalty payments associated with worldwide sales of the developed vaccines.
Under the collaboration with Sanofi Pasteur, Translate Bio will be responsible for clinical manufacture and will be entitled to additional payments under a separate supply agreement to be established.
“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,” John Shiver, SVP, R&D, Sanofi Pasteur, said in a statement. “The Translate Bio platform may allow us to further address medical needs worldwide, including those not readily accessible using conventional vaccine strategies.”
Sales, Clinical Setbacks
Sanofi is looking to broaden Sanofi Pasteur’s R&D efforts following a 0.9% year-over-year dip in sales during the first quarter, to €711 million ($839 million). While sales grew 8.3% for all of 2017, to €5.101 billion ($6.020 billion), they only inched up 1.2% during Q4, to €1.385 billion ($1.635 billion).
The vaccine unit is looking to bounce back from setbacks: Sanofi took a fourth-quarter charge for its pioneering Dengue vaccine Dengvaxia® to reflect reduced sales after long-term clinical trial data showed the vaccine could increase the severity of the disease in people who were not previously infected.
And in December 2017, Sanofi halted development of its Clostridium difficile candidate after the Independent Data Monitoring Committee for the Phase III Cdiffense™ clinical trial (NCT01887912) concluded that the vaccine was unlikely to meet the study’s primary endpoint of efficacy in adults ages 50 years-plus who are at risk for C. difficile infection and received at least one injection of the vaccine.
Translate Bio says its mRNA therapeutic platform (MRT) is designed to develop product candidates that deliver mRNA carrying instructions to produce intracellular, transmembrane, and secreted proteins for therapeutic benefit.
The company reasons that it can apply the MRT platform to a broad range of diseases caused by insufficient protein production or where production of proteins can modify disease—including diseases that affect the lung, liver, eye, central nervous system, lymphatic system, and circulatory system.
mRNA Platform “Potential”
“We believe that this partnership validates the potential of our mRNA platform, and also enables us to apply our mRNA technology beyond the current therapeutic applications that we are pursuing in cystic fibrosis and ornithine transcarbamylase deficiency, ultimately advancing our goal of delivering innovative medicines to patients,” added Translate Bio CEO Ronald Renaud.
Translate Bio emerged in January 2017 under the name RaNA Therapeutics when it acquired the MRT mRNA therapy platform from Shire—whose subsidiaries developed the technology—for an undisclosed price. At the time, the group of Shire MRT employees who had focused on developing the technology since 2008 joined RaNA to continue advancing the platform in cystic fibrosis and urea cycle disorders.
On April 12, Translate Bio said it won FDA clearance to begin a first-in-humans Phase I/II trial to assess the mRNA candidate MRT5005 in cystic fibrosis, with dosing of patients expected to begin “in mid-2018.”
The randomized, double-blind, placebo-controlled trial is designed to enroll at least 32 adult patients with cystic fibrosis who have at least one Class I or Class II mutation. The trial’s primary endpoint will be the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization.
Translate Bio’s deal with Sanofi is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 in the U.S.