In a regulatory filing with the U.S. Securities and Exchange Commission (SEC), Translate Bio indicated that the COVID-19 vaccine it is developing with Paris-based Sanofi induced an immune response in non-human studies. The companies expect to begin human clinical trials in November.
On June 23, Sanofi Pasteur, the vaccines business unit of Paris-based Sanofi and Lexington, Massachusetts-based Translate Bio, announced 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 paid 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.”
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 technology used in these preclinical studies is similar to that used by Moderna and the Pfizer and BioNTech group. The vaccine candidate uses a mRNA segment that codes for a viral protein, which when injected into the body, causes cells to produce the protein, which stimulates an immune response against the virus.
The data “demonstrate that two immunizations of the mRNA vaccine induced high neutralizing titers that are comparable to the upper range of those observed in infected humans,” according to the filing.
Sanofi is also developing a different COVID-19 vaccine with GlaxoSmithKline. It uses recombinant protein technology that Sanofi leveraged to produce an influenza vaccine and uses GSK’s established pandemic adjuvant technology.
In July, Operation Warp Speed made a deal with GSK and Sanofi worth $2.1 billion to supply an initial 100 million doses of their vaccine candidate. The funds support development of the vaccine, including clinical trials and the initial 100 million doses.