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* Favourable immune response in mice, monkeys for vaccine
* Human clinical trial expected to begin in fourth quarter
By Matthias Blamont
PARIS, Oct 15 (Reuters) - 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.
Sanofi is also developing another COVID-19 vaccine candidate
with British drugmaker GlaxoSmithKline and started a
clinical trial in September, with the first results expected by
the end of the year.
(Reporting by Matthias Blamont; Editing by Josephine Mason and
Alexander Smith)
