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. Initial manufacturing is planned to take place at Lonza’s site in Portsmouth, New Hampshire, with a second phase planned at its Ibex facility in Visp, Switzerland.
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. Over time, the parties intend to establish additional production suites across Lonza’s worldwide facilities. Ultimately, this will allow 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.
Manufacturing operations at Lonza US are partially covered by Moderna’s ‘up to’ $483M contract with the US Biomedical Advanced Research and Development Authority (BARDA). BARDA agreed to support late-stage clinical development programmes of mRNA-1273.
mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein. The vaccine candidate is under study in a Phase I open-label, dose-ranging trial of mRNA-1273 (NCT04283461) in males and non-pregnant females, 18 to 55 years old,
occurring at Kaiser Permanente Washington Health Research Institute in Seattle.
The 45-patient study is designed to assess the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults. The first patient was dosed in March.
On April 27, Moderna submitted an IND application to the FDA for Phase II and late-stage studies of mRNA- 1273. Moderna said it received initial feedback from the FDA on the design of the planned study, which is expected to begin in the second quarter of 2020.
The Phase II trial will be designed to assess 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. Moderna said it intends to enroll 600 healthy participants across two cohorts of adult ages, 18-55 years (n=300) and 55 years and above (n=300). Participants will be followed for 12 months after receiving the second vaccination.