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Sanofi and Translate Bio eye launch of phase 1/2 COVID-19 vaccine study

Preclinical data for mRNA-based vaccine supports clinical development

Sanofi and Translate Bio’s mRNA-based COVID-19 vaccine induced high antibody levels in preclinical studies, leading to the production of neutralising antibodies in mice and macaques.

The findings come from preclinical studies of the vaccine candidate, MRT5500, to demonstrate its potential to produce neutralising antibodies in animals against SARS-CoV-2, which causes COVID-19. The results were published on the pre-print server bioRxiv.

MRT5500 induced dose-dependent levels of binding antibodies and neutralising antibodies specific to the SARS-CoV-2 spike protein in mice, as well as 100% seroconversion at all dose levels after a single shot.

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. However, in the higher dose groups, titers were detected after one shot of MRT55000 and were stronger following the second administration.

In macaques (non-human primates), the majority of subjects developed neutralising antibodies reactive to the SARS-CoV-2 spike protein after the first administration of MRT5500, with thee antibodies enhanced following a second shot.

Researchers also tested a specific immune reaction – Th1-biased T cell response – which in previous studies has been found to accelerate in patients with mild cases of COVID-19. In the preclinical study, all mice and macaques immunised with MRT5500 exhibited a Th1-biased T cell response against SARS-CoV-2.

According to Sanofi and Translate Bio, the animal study data supports the selection of MRT5500 for clinical development, with a phase 1/2 trial expected to begin by the end of the year.

Sanofi is also developing another COVID-19 vaccine with GlaxoSmithKline (GSK) using the same recombinant protein-based manufacturing technology as one of Sanofi’s seasonal influenza vaccines, combined with GSK’s pandemic adjuvant platform.

The companies launched a phase 1/2 study of the candidate in September and expect first results from this trial in early December, to support the initiation of a phase 3 study before the end of the year.

Novel mRNA-based technology has been a new focus in the development of a COVID-19 vaccine, despite the fact that no vaccine using this technology has been approved anywhere in the world.

Another company, Moderna, is also developing a promising mRNA-based vaccine candidate for COVID-19, which entered a phase 3 clinical trial in July.

Moderna and the US National Institutes of Health (NIH) are collaborating on the late-stage COVE trial, which will evaluate the candidate, mRNA-1273, in 30,000 study participants.

Article by
Lucy Parsons

16th October 2020

From: Research

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