First batches of mRNA-1273 expected to be manufactured at Lonza US in July 2020
Moderna, a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, and Lonza, have announced a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future.
Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the United States and Switzerland for the manufacture of mRNA-1273 at both sites.
Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza US in July 2020.
In time, the parties intend to establish additional production suites across Lonza’s worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to 1 billion doses of mRNA-1273 per year for use worldwide assuming the currently expected dose of 50 µg.
The manufacturing facilities at Lonza complement Moderna’s ongoing US production efforts, which continue to ramp up to prepare for the further clinical development and commercialisation of mRNA-1273.
A portion of the funding for the establishment of manufacturing operations at Lonza US is covered by Moderna’s contract with Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services, which was announced on 16 April 2020.
BARDA will support late-stage clinical development programmes of mRNA-1273. Lonza’s experience in scaling manufacturing of innovative medicines, including support for more than 50 commercial approvals across regulatory jurisdictions, will support Moderna for global supply.
On 27 April 2020, Moderna announced that it submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for Phase II and late stage studies of mRNA-1273 if supported by safety data from the Phase I study.
Moderna has received initial feedback from the FDA on the design of the planned Phase II study, which is expected to begin in the second quarter of 2020.
This study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each subject will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations.
The company intends to enrol 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Participants will be followed through 12 months after the second vaccination.