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Moderna submits application to advance coronavirus vaccine testing

Pivotal phase 3 trial could begin in autumn this year depending on trial results

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Biotech company Moderna has submitted a new drug application to the US Food and Drug Administration (FDA) to advance its coronavirus vaccine candidate into phase 2 testing.

At the beginning of April, Moderna chairman Noubar Afeyan told CNBC that phase 2 trials of the company’s vaccine – named mRNA-1273 – could begin as early as spring. Now that Moderna has filed with the FDA to take the candidate into the next stage of testing, it is looking increasingly likely that the phase 2 study could begin in May.

However, before Moderna can take mRNA-1273 into the later stages of clinical testing, it must demonstrate safety and efficacy in the phase 1 study, which is currently being led by the US National Institute of Allergy and Infectious Diseases (NIAID).

The planned phase 2 study will evaluate the safety, reactogenicity and immunogenicity of two doses of mRNA-1273 administered 28 days apart. Study participants will either receive a placebo shot, a 50 μg dose or a 250 μg dose at both vaccinations.

Moderna will enrol 600 healthy participants into two cohorts, which includes adults aged 18-55 years or older adults aged 55 years or above. If all goes to plan in both the phase 1 and phase 2 studies, Moderna added that a pivotal phase 3 trial could begin in autumn this year.

"We look forward to launching this phase 2 study as soon as possible, which will provide important information about the safety, reactogenicity and immunogenicity of mRNA-1273." said Tal Zaks, Moderna’s chief medical officer.

The planning for the next stages of study was supported by funding from the US Biomedical Advanced Research and Development Authority (BARDA), which came from a deal worth up to $483m announced a few weeks ago.

The BARDA funding will also go towards supporting the late-stage clinical development programmes, as well as the eventual scale-up and expansion of mRNA-1273 manufacturing.

So far, the phase 1 study of the vaccine candidate has completed initial enrolment of 45 health adult volunteers between the ages of 18-55, across three dose cohorts (25 µg, 100 µg and 250 µg).

Moderna is also enrolling a further six cohorts, including three cohorts of older adults between the ages of 56-70 and three cohorts of elderly adults aged 71 and above. The company has not yet revealed when the data from the original cohort is set to be released, only that it will reported ‘once available’.

Article by
PMGroup

28th April 2020

From: Research

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