Clinical trials of an experimental vaccine against COVID-19 which is being developed by France’s Sanofi and U.S. biotech firm Translate Bio are on track to begin before the end of the year after positive results in tests on animals.
Sanofi and Translate Bio said in a statement on Thursday that the results from pre-clinical trials showed two doses of the MRT5500 vaccine induced a “favourable” immune response in mice and monkeys. There is no internationally-approved vaccine to protect against COVID-19, which has killed more than 1 million people around the world and triggered economic chaos.
More than 40 drugmakers and research groups are conducting human trials to develop vaccines, with seven which have progressed to the late stages of tests. The finding published on Thursday is similar to that released in August by Translate Bio, which at the time said it aimed to launch clinical trials in November.
Sanofi and Translate Bio confirmed that a phase 1/2 trial on humans would begin in the fourth quarter to test for safety and to determine the dosage before a possible final Phase 3 trial. They did not provide a precise starting date.
In mice, they said four dose levels had been assessed using a two-dose vaccination schedule, adding that the pre-clinical results were undergoing peer review for potential publication. “Two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients,” the companies said.
In non-human primates (NHPs), Sanofi said three dose levels had been evaluated with a similar two-dose approach. “The preclinical results we report in this paper demonstrate the ability of MRT5500 to elicit a favorable immune response in both mice and non-human primates,” Ronald Renaud, Chief Executive of Translate Bio, said.
The vaccine candidate uses a technology known as messenger RNA (mRNA) which instructs cells in the body to make specific coronavirus proteins that then produce an immune response. Several companies are also using this approach to develop a vaccine, including U.S. companies Moderna and Pfizer whose candidates have reached late-stage trials.