Ingredient supplier Lonza is joining the high-stakes, fast-track business of discovering and commercializing a potential vaccine against the novel coronavirus, SARS-CoV-2.
Headquartered in Switzerland with a U.S. base in New Jersey, Lonza is partnering with Moderna, a clinical stage biotechnology company pioneering messenger RNA therapeutics and vaccines to bring about a larger-scale manufacture of vaccines and other next-generation medicines.
“We are very pleased to partner with Lonza, which shares our commitment to rapidly addressing this pandemic which has created a global health crisis,” said Stephane Bancel, CEO of Moderna. “This long-term strategic collaboration agreement will enable Moderna to accelerate, by 10 times, our manufacturing capacity.”
Lonza is renowned for supplying a small suite of high-quality branded ingredients to supplements and functional food manufacturers. These include Carnipure, a branded L-carnitine ingredient used for performance and infant nutrition applications; ResistAid, a larch arabinogalactan for immune health; and niacin, used for both supplement and pharmaceutical applications. In 2017, Lonza also acquired Capsugel Consumer Health & Nutrition, the leading capsule manufacturer.
“Lonza’s global presence and expertise are critical as we scale at unprecedented speed,” said Bancel. “Our common goal is to potentially enable manufacturing of up to 1 billion doses of mRNA-1273.”
The two companies announced a 10-year strategic collaboration agreement to scale up the manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future.
The vaccine is currently in Phase 1 trials but Moderna is moving extremely quickly (63 days from sequence selection to Phase 1 study dosing).
Moderna announced on April 27 that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Phase 2 and late-stage studies of mRNA-1273 if supported by safety data from the Phase 1 study.
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 U.S. in July 2020.
“The current pandemic illustrates the need to combine the best science with resilient supply chains that can scale,” said Albert M. Baehny, chairman and interim CEO of Lonza. “Moderna’s technology represents a significant opportunity to change the way we protect people against disease.”
The fast-track of manufacturing is not just for Moderna’s mRNA vaccine (mRNA-1273) against the SARS-CoV-2 coronavirus vaccine, but for as many as nine other vaccine candidates for other viruses. The agreement also extends to additional Moderna products in the future, depending on clinical trial results.
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), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, which was announced April 16.
BARDA will support late-stage clinical development programs 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.
Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which is expected to begin in the second quarter of 2020. That 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 mcg or a 250 mcg dose at both vaccinations. 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.
Moderna’s mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH.
The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on Feb. 7, and underwent analytical testing. It was shipped to NIH on Feb. 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. A summary of the company’s work to date on SARS-CoV-2 can be found here.
Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia.
Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.