Moderna, Inc., a clinical stage biotechnology company developing messenger RNA (mRNA) therapeutics and vaccines, and Lonza Ltd. have entered a 10-year strategic collaboration for large scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against coronavirus (SARS-CoV-2) and additional Moderna products in the future.
 
The companies plan to establish manufacturing suites at Lonza’s facilities in the U.S. 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 U.S. in July 2020.

The companies also 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 U.S. manufacturing efforts, which continue to ramp up to prepare for the further clinical development and commercialization of mRNA-1273.
 
A portion of the funding for the establishment of manufacturing operations at Lonza U.S. is covered by Moderna’s contract with Biomedical Advanced Research and Development Authority (BARDA), announced April 16th. BARDA will support late-stage clinical development programs of mRNA-1273.

Moderna submitted an Investigational New Drug (IND) application to the U.S. FDA on April 27 for Phase II and late stage studies of mRNA-1273, which are expected to begin in 2Q20. This study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The company intends to enroll 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.