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The goal of the collaboration is to manufacture up to one billion does per year of mRNA-1273, Moderna’s vaccine against the novel coronavirus.
On May 1, 2020, Lonza and Moderna, a Cambridge, MA-based clinical-stage biotechnology company specializing in messenger RNA (mRNA) therapeutics and vaccines, announced a 10-year strategic collaboration agreement to enable larger-scale manufacture of Moderna’s mRNA vaccine, mRNA-1273, against SARS-CoV-2, the novel coronavirus, and additional Moderna products in the future.
Under the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the United States and Switzerland and will manufacture mRNA-1273 at both sites. Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of the vaccine at Lonza US in July 2020. Over time, the companies intend to establish additional production suites across Lonza’s worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to one 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 manufacturing efforts, which Moderna continues to ramp up in preparation for the further clinical development and commercialization of mRNA-1273.
A portion of the funding used to establish the manufacturing operations at Lonza US will be 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, as announced on April 16, 2020. BARDA will support late-stage clinical development programs of mRNA-1273.
mRNA-1273 was selected by Moderna in collaboration with investigators from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, or 42 days from sequence selection. The first participant in the NIAID-led Phase I study was dosed on March 16, or 63 days from sequence selection to Phase I study dosing.
Moderna submitted an investigational new drug (IND) application to FDA in April 2020 for Phase II and late stage studies of the vaccine, if supported by safety data from a Phase I study. Moderna has received initial feedback from 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.
“We are very pleased to partner with Lonza, which shares our commitment to rapidly addressing this pandemic which has created a global health crisis. This long-term strategic collaboration agreement will enable Moderna to accelerate, by 10-times, our manufacturing capacity for mRNA-1273 and additional products in Moderna’s large clinical portfolio. Lonza’s global presence and expertise are critical as we scale at unprecedented speed. Our common goal is to potentially enable manufacturing of up to [one] billion doses of mRNA-1273,” said Stéphane Bancel, CEO, Moderna, in a company press release.
“Moderna’s technology represents a significant opportunity to change the way we protect people against disease. The current pandemic illustrates the need to combine the best science with resilient supply chains that can scale. We are fully committed to leveraging our global network and experience in manufacturing technologies to support Moderna’s manufacture of mRNA-1273 as well as collaborating on future Moderna products,” added Albert M. Baehny, chairman and CEO ad interim, Lonza, in the press release.