Sanofi’s Uses Latecomer COVID Data To Highlight Bigger mRNA Strategy
Executive Summary
The French drug maker isn’t moving its mRNA COVID-19 vaccine into Phase III, instead focusing on a GSK-partnered protein SARS-CoV-2 vaccine and applying mRNA technology elsewhere.
If Sanofi seems late to the party in announcing results for its messenger RNA (mRNA) vaccine against COVID-19, that’s because it is no longer even advancing that COVID-19 program but is using the early data more to demonstrate the broad potential of the mRNA technology it gained by acquiring Translate Bio.
On 28 September, Sanofi announced positive interim results from a 333-participant Phase I/II study of its mRNA-based COVID-19 vaccine candidate, showing that neutralizing antibody seroconversion appeared in 91%-100% of participants two weeks after initial injection, at all three dose levels tested. Along with the high seroconversion rate, the vaccine’s safety and tolerability profile were also comparable to other unmodified mRNA COVID-19 vaccines.
But rather than try to bring forward another mRNA vaccine for COVID-19 to compete against Moderna Inc.’s mRNA-1273 and Pfizer Inc./BioNTech SE’s Comirnaty, Sanofi is shelving the COVID-19 program and focusing on other diseases for its mRNA technology, gained from Translate Bio. Sanofi announced in August the $3.2bn acquisition of the remainder of Translate Bio, a company in which it already controlled a 7% stake, having first partnered with it in 2018. (Also see "Sanofi Goes All The Way In mRNA With Translate Bio Buy" - Scrip, 3 Aug, 2021.)
Sanofi told Scrip that the results offer a kind of proof of concept for the mRNA technology across a broader range of indications.
In June, Sanofi launched a Phase I study of an mRNA-based influenza vaccine and plans to launch clinical studies of an influenza vaccine with modified mRNA across two formulations with different nanoparticles in 2022. The company said the flu vaccine plans were part of a larger move to modified mRNA in other diseases as well.
Regarding the pandemic, Sanofi has promising results from the Phase III adjuvanted recombinant protein vaccine against COVID-19 that it is developing with GlaxoSmithKline plc, with data on use as a universal booster shot expected by the end of the fourth quarter.
“Our ambition is to make a significant and relevant contribution to the ongoing pandemic,” the company said. “From a public health perspective, mRNA COVID vaccines are widely available today, so it does not make sense for us to further advance our mRNA COVID vaccine into Phase III.”
Looking Past The Pandemic
The goal now, the company said, is to develop what it called the next generation of mRNA vaccines and technology that better meets public health needs, with fewer side effects, better immune response and a more stable profile.
“We target different infectious diseases, including influenza, as well as different strategic areas such as immunology, oncology and rare diseases, where the means of protection can be improved or are currently non-existent,” the company said.
Apart from COVID-19 and influenza, Translate Bio’s pipeline includes a range of therapeutic candidates, with lead candidate MRT5005 in Phase I/II development for cystic fibrosis. Its preclinical pipeline includes programs for other viral and bacterial pathogens, liver disease, and lung diseases like primary ciliary dyskinesia and pulmonary arterial hypertension.
But Sanofi’s focus on modified mRNA is strategically important as well.
“The company’s comments also suggested that in the future their development efforts will focus on vaccines containing modified mRNA, rather than unmodified, which is suggestive of some limitations to the breadth, depth or durability of the immune response they saw to the original unmodified COVID vaccine from Translate Bio,” SVB Leerink analyst Geoffrey Porges said in a 28 September note.
Sanofi is not alone in exploring next-generation RNA products. In 23 September, AstraZeneca PLC partnered with VaxEquity Ltd to develop vaccines and therapeutics based on self-amplifying RNA (saRNA). (Also see "AstraZeneca Moves Into Self-Amplifying RNA With VaxEquity Deal" - Scrip, 23 Sep, 2021.) Another company, Seqirus, is pursuing development of self-amplifying mRNA (sa-mRNA). (Also see "Flu Vaccine Leader Seqirus Invests In Self-Amplifying mRNA" - Scrip, 20 Aug, 2021.)
Success with COVID-19 has also provided validation for Moderna’s and Pfizer/BioNTech’s mRNA technology and the firms are already looking past the pandemic.
In July, Moderna dosed the first subject in its Phase I/II study of mRNA-1010, a quadrivalent vaccine against seasonal influenza, while also developing vaccines against cytomegalovirus, Zika virus, HIV and others. (Also see "Can Moderna Repeat COVID-19 Success In Influenza Market?" - Scrip, 7 Jul, 2021.) Pfizer/BioNTech have their own influenza vaccine candidate, BNT161, which uses sa-mRNA technology, while BioNTech’s mRNA pipeline includes a cancer vaccine, BNT111, in development with Regeneron Pharmaceuticals, Inc.’s PD-1 inhibitor Libtayo (cemiplimab). (Also see "COVID-19 Vaccine Results A Breakthrough Moment For BioNTech" - Scrip, 11 Nov, 2020.)