Moderna and Lonza Announce Worldwide Strategic Collaboration to Manufacture Moderna?s Vaccine (mRNA-1273) Against Novel Coronavirus
Collaboration goal to enable manufacturing of up to 1 billion doses per year
Technology transfer expected to begin in June 2020
First batches of mRNA-1273 expected to be manufactured at Lonza U.S. in July 2020
Collaboration leverages Lonza?s worldwide expertise in technology transfer and manufacturing
May 01, 2020 12:50 AM Eastern Daylight Time
CAMBRIDGE, Mass. & BASEL, Switzerland--(BUSINESS WIRE)--Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, and Lonza Ltd. (SIX: LONN) today 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 U.S. in July 2020. Over 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 ?g. 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), 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, 2020. 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. ?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 St?phane Bancel, Moderna?s Chief Executive Officer. ?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 1 billion doses of mRNA-1273.? ?Moderna?s technology represents a significant opportunity to change the way we protect people against disease,? said Albert M. Baehny, Lonza?s Chairman and CEO?ad interim. ?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.? On April 27, 2020, Moderna?announced?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. 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. 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 ?g or a 250 ?g 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. About mRNA-1273 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 February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 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. About the NIAID-led Phase 1 Study An open-label Phase 1 study of mRNA-1273 is being conducted by the National Institute of Allergy and Infectious Diseases under its own Investigational New Drug (IND) application in the U.S. The Phase 1 study, which began on March 16, 2020, completed enrollment of 45 healthy adult volunteers ages 18 to 55 years in the original three dose cohorts (25 ?g, 100 ?g and 250 ?g). The study is?enrollingan additional six cohorts: three cohorts of older adults (ages 56-70) and three cohorts of elderly adults (ages 71 and above). Data from the original cohort of healthy adult volunteers ages 18 to 55 years will be reported once available. About Moderna?s Prophylactic Vaccines Modality 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. The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform. Moderna currently has?nine development candidates?in its prophylactic vaccines modality, including: Vaccines against respiratory infectionsModerna and Lonza announce worldwide strategic collaboration to manufacture Moderna?s vaccine (mRNA-1273) against novel coronavirus
Tweet this
- Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
- RSV vaccine for young children (mRNA-1345)
- Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
- Novel coronavirus (SARS-CoV-2) vaccine (mRNA-1273)
- Influenza H7N9 (mRNA-1851)
- Cytomegalovirus (CMV) vaccine (mRNA-1647)
- Zika vaccine (mRNA-1893 with BARDA)
- Epstein-Barr virus (EBV) vaccine (mRNA-1189)