Sanofi’s SNY global vaccines business unit Sanofi Pasteur and Translate Bio, Inc. TBIO announced promising pre-clinical data on their coronavirus vaccine candidate MRT5500. Pre-clinical data demonstrated a favorable immune response profile against SARS-CoV-2 in mice and non-human primates.
The preclinical data showed that two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients.
The companies evaluated four dose levels — 0.2, 1, 5 and 10 µg per dose — of MRT5500 in mice and three dose levels — 15, 45 and 135 µg per dose — in non-human primates (NHPs). The vaccine has been developed as a two-administration vaccination schedule, three weeks apart.
Pre-clinical findings from the mice study showed that the candidate induced higher levels of binding antibodies and neutralizing antibodies specific to the SARS-CoV-2 spike protein with higher level of dose. First administration of MRT5500 achieved 100% seroconversion at all dose levels and a further increase in titers was observed following a second administration in the mice.
MRT5500 induced significantly higher levels of neutralizing antibody titers in NHPs compared to human convalescent sera by day 35. The candidate exhibited a Th1-biased T cell response against SARS-CoV-2 in both mice and NHPs.
These outcomes supported selection of the candidate for clinical development. A phase I/II study is planned for late 2020 to evaluate MRT550 in humans. Please note that Sanofi and Translate Bio have a collaboration agreement to develop novel mRNA vaccines, aimed at broadly addressing all current and future infectious diseases including COVID-19.
Shares of Sanofi have dipped 0.5% so far this year compared with the industry’s decrease of 0.9%.
Apart from MRT5500, Sanofi is developing another COVID-19 vaccine candidate in collaboration with Glaxo GSK. Sanofi’s recombinant protein-based technology is being combined with Glaxo’s pandemic adjuvant technology to develop an adjuvanted COVID-19 vaccine. In September, a phase I/II study was initiated to evaluate their adjuvanted vaccine. Initial results from the study are expected in early December 2020. If phase I/II study data is favorable, the companies are likely to begin a pivotal phase III study before the end of this year.
Meanwhile, we note that there are other players in the coronavirus vaccine field with a few already in late-stage development. Leading coronavirus vaccine developers include Moderna MRNA, Pfizer/BioNTech, AstraZeneca/Oxford University and J&J. Currently, Pfizer/BioNTech’s mRNA-based coronavirus vaccine candidate is leading the race with initial data from a late-stage study expected by the end of this month. Positive outcomes will likely support an emergency use authorization from the FDA.
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