Sanofi Pasteur, the vaccines business unit of Paris-based Sanofi, and Lexington, Massachusetts-based Translate Bioannounced the expansion of an existing collaboration to develop mRNA vaccines for infectious diseases. The original deal was entered in 2018.
Under the new deal expansion, Sanofi will pay Translate Bio $425 million up front, with $300 million in cash and $125 million a private placement common stock investment at $25.59 per share, a 50% premium on the 20-day moving average share price before signing. Translate Bio will be eligible for possible milestones and other payments up to $1.9 billion, which includes $450 million that fell under the 2018 agreement.
Of the possible milestones, about $360 million are expected over the next few years, including COVID-19 vaccine development milestones. Also, Translate Bio is up for tiered royalties based on global sales of any developed vaccines.
Sanofi is paying all costs during the collaboration period. Sanofi Pasteur will receive exclusive global rights for infectious disease vaccines.
“As all eyes are on prevention of infectious disease through vaccines, this is a pointed moment in time where we are called upon to seek innovative ways to protect public health,” said Thomas Triomphe, executive vice president, Sanofi Pasteur. “We are excited by the novel technology and expertise Translate Bio brings, and we believe that adding this mRNA platform to our vaccines development capabilities will help us advance prevention against current and future infectious diseases.”
To date, no mRNA vaccines have been approved for the market. This is fairly new technology, where messenger RNA that codes for a section of the viral genome is injected into the body, where it integrates into cells and churns out the molecule it codes for. This molecule then should trigger the immune system to recognize the virus so that if it encounters the virus, will attack it before it can widely affect the patient.
The deal will give Sanofi about a 7.2% stake in Translate Bio in addition to the broad rights to vaccines. Sanofi expects its mRNA COVID-19 vaccine candidate to enter the clinic by the end of the year, and if everything goes well, could be up for regulatory approval in the second half of 2021.
Translate Bio specializes in mRNA therapeutics. Under the partnership, Translate Bio is leveraging its mRNA platform to discover, design and manufacture vaccine candidates. Sanofi Pasteur is one of the leading vaccine companies in the world and will both advise and assist in advancing those candidates into clinical trials, regulatory applications and commercialization.
In addition to multiple COVID-19 vaccine candidates, the two companies are working on an mRNA vaccine candidate against influenza with plans to begin clinical trials in mid-year 2021. There are also other mRNA vaccine development programs they are working on involving another virus as well as a bacterial pathogen.
“The expansion of our collaboration with Sanofi Pasteur validates the progress we’ve made in the development of mRNA vaccines for infectious diseases since our work together began in 2018 and also speaks to the potential of our mRNA platform,” said Ronald Renaud, chief executive officer of Translate Bio. “We are excited to work with Sanofi in this broadened capacity with the goal of ultimately delivering vaccines on a global scale, a need underscored by the current pandemic. Translate Bio will also be well positioned financially to continue to build upon our internal capabilities with a focus on advancing innovations in platform discovery and on the development of ongoing and additional preclinical therapeutic programs as we aim to bring multiple programs towards clinical development.”
Sanofi and Translate Bio announced on March 27 that they would collaborate on an mRNA vaccine for COVID-19. Translate Bio was producing multiple mRNA constructs as well as its mRNA platform. They were also building out a dedicated manufacturing space via a contract manufacturing organization to accommodate at least two 250-gram batches per month.
Other companies, notably Moderna, and a Pfizer and BioNTech collaboration, are utilizing mRNA technology to develop their vaccines. At this point, Moderna appears to be furthest along, with plans to initiate a 30,000-patient Phase III clinical trial in July.
Sanofi’s chief executive officer Paul Hudson noted recently that those ahead were not necessarily assured of securing victory.
“There are companies moving faster,” he said, “but let us be brutally clear, speed has three downsides. They are using existing work, in many cases done for SARS; it is likely not to be as efficacious; and there is no guarantee on supply in large volumes.”
He believes that Sanofi’s probability of success is “higher than anybody else.”
Sanofi and GlaxoSmithKline are also working together on an adjuvanted vaccine for COVID-19. Sanofi is supplying its S-protein COVID-19 antigen based on recombinant DNA technology. GSK is contributing its pandemic adjuvant technology. An adjuvant is a substance that causes a higher immune response, which generally allows for smaller doses of the vaccine.