Sanofi, Translate Bio launch early study of mRNA flu vaccine – PMLiVE

Sanofi and Translate Bio have launched a phase 1 clinical trial of their mRNA-based investigational seasonal flu vaccine, the companies has announced in a statement.

Sanofi and Translate Bio have developed and will evaluate two different formulations of the vaccine – named MRT5400 and MRT5401 respectively – in the early-stage study. The difference between the formulations is in the lipid nanoparticle (LNP) that contains the mRNA.

The phase 1 trial will evaluate the safety and immunogenicity of a monovalent flu vaccine, coding for the hemagglutinin protein of the A/H3N2 strain of the flu virus.

Flu seasons that are dominated by this strain are often more severe, particularly among individuals who are considered to be at risk, including older adults and younger children.

Sanofi and Translate are expecting interim data from the phase 1 trial by the end of 2021, with the future of the clinical development programme dependent on the outcomes from the initial study.

“We believe that mRNA technology could have several advantages for a seasonal flu application including the potential ability to demonstrate robust immune responses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity. We look forward to evaluating the potential of these mRNA influenza vaccine candidates in this phase 1 clinical trial,” said Ronald Renaud, chief executive officer of Translate Bio.

In March, the companies launched a phase 1/2 trial of their other partnered vaccine candidate – a potential mRNA-based jab for COVID-19 named MRT5500.

In preclinical studies, the vaccine candidate induced high antibody levels and produced neutralising antibodies in mice and macaques.

Neutralising antibody titers were observed across all dose levels tested – 0.2, 1, 5 and 10 µg per dose – after a two-dose administration regimen.

Sanofi and Translate Bio initially entered into collaboration and an exclusive licence agreement to develop mRNA vaccines for up to five infectious disease pathogens.

This agreement was amended in June 2020, when Sanofi expanded the deal with an upfront payment of $300m in cash and $125m in an equity investment to include the development of a novel mRNA vaccine for COVID-19.

Since the beginning of the pandemic, mRNA-based technology has been at the forefront of the COVID-19 vaccine race.

Two COVID-19 vaccines using this technology – the Pfizer/BioNTech vaccine and Moderna vaccine – are now approved for use in various countries across the world.

Beyond infectious diseases, BioNTech is utilising mRNA technology for the development of a potential cancer vaccine, BNT111, which was recently advanced into phase 2 testing for patients with advanced melanoma.

BNT111 is being evaluated in combination with Sanofi/Regeneron’s Libtayo (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable stage 3 or 4 melanoma.