Sanofi and Translate Bio today said they expanded their two-year-old collaboration to develop mRNA vaccines for infectious diseases, with the phama giant nearly tripling to more than $2.3 billion its potential payout to the Lexington, MA, biotech, and the companies increasing from five to seven the maximum number they plan to develop under that partnership.

The additional vaccines will consist of candidates against COVID-19 and influenza. Sanofi and Translate Bio said their COVID-19 collaboration, which began in March, has progressed to evaluating multiple vaccine candidates in vivo for immunogenicity and neutralizing antibody activity, with the goal of supporting the selection of a lead candidate.

The companies aim to launch a first-in-human clinical trial of the COVID-19 vaccine in the fourth quarter.

“We have more than one RNA construct,” Translate Bio CEO Ronald C. Renaud Jr. told GEN in May in an interview about the company’s progress in developing a COVID-19 vaccine candidate. “Our lead one is, it should be no surprise, it’s the prefusion Spike glycoprotein. That’s what we’re focused on as our lead program, but it’s safe to say that we’re also looking at additional constructs that address some interesting epitopes.

“We learned a lot since the initial sequence has come out, and there has been some additional research that has highlighted potential vulnerabilities on that spike glycoprotein,” Renaud said. “So, I think we’d be remiss if we didn’t think it would be worth looking at some of these other interesting epitopes, and see if we can’t produce an antigen against them. But that doesn’t take anything away from the prefusion spike protein.”

That vaccine will apply the proprietary MRT™ platform that Translate Bio acquired from Shire in 2017. Translate Bio creates mRNA that encodes functional proteins, and encapsulates the mRNA in a lipid nanoparticle (LNP). When that mRNA is delivered to the target cell, the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.

“A Perfect platform”

“We have LNPs that we have identified as candidates to do just that” for the COVID-19 vaccine, Renaud added. “This is a perfect platform messenger RNA for addressing a pandemic-like situation.”

Under their expanded agreement, Sanofi agreed to pay Translate Bio a total $425 million upfront, consisting of $300 million cash and a private placement common stock investment of $125 million based on a share price of $25.59, representing a 50% premium to the 20-day moving average share price prior to signing. The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.

Sanofi also agreed to pay Translate Bio up to $1.94 billion in payments tied to achieving development, regulatory, manufacturing, and commercialization milestones—including $450 million that Sanofi agreed to pay when the companies launched their up-to-$805 million-plus collaboration in June 2018.

The potential milestones and other payments including approximately $360 million that Translate Bio anticipates receiving over the length of the agreement, inclusive of COVID-19 vaccine development milestones.

Investors signaled approval of the expanded partnership with a stock buying surge that shares of Translate Bio up 47% to $23.87 per share as of the close of trading 4 p.m., from $16.24 yesterday.

Option for additional year

Sanofi and Translate Bio also extended the length of their agreement from the initial three-year term ending in 2021 until June 2022, with an option for Sanofi Pasteur to extend for one additional year. If Sanofi Pasteur chooses to exercise that additional one-year option, it agreed in return to pay Translate Bio an additional $75 million, according to a Translate Bio regulatory filing detailing the expanded collaboration.

According to that filing, Sanofi Pasteur may also elect to expand the collaboration to develop mRNA vaccines for up to an additional three infectious disease pathogens.

Also, Translate Bio is entitled to receive development, regulatory, and sales milestone payments of up to $148 million for each “licensed field” other than SARS-CoV-2; plus development, regulatory, and sales milestone payments of up to $250 million in SARS-CoV-2, and one-time manufacturing milestone payments of up to $200 million.

Translate Bio is also eligible to receive tiered royalty payments based upon worldwide sales of the developed vaccines. Sanofi Pasteur agreed to pay for all costs during the collaboration term, but will receive exclusive worldwide rights for infectious disease vaccines developed through the partnership.

Sanofi and Translate Bio also said they are advancing an mRNA vaccine development candidate against influenza through preclinical studies with clinical trial initiation anticipated in mid-year 2021. Additional mRNA vaccine development programs under the collaboration include another viral pathogen and a bacterial pathogen.

“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,” Thomas Triomphe, executive vice president, Sanofi Pasteur, said in a statement. “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.”

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