Cambridge (MA), USA and Basel, Switzerland, 1 May 2020 – 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 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), part of theOffice of the AssistantSecretary for Preparedness and Response within theU.S. Department of Health and Human Services, which was announced 16 April, 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.
On 27 April, 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. Modernahas 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 μg or a 250 μg 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.
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for aprefusion stabilizedform of the Spike (S) protein, which was selected byModernain collaboration with investigators from Vaccine Research Center(VRC) at theNational 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 onFebruary 7, 2020and underwent analytical testing; it was shipped to NIH onFebruary 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 theNational 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 µg, 100 µg and 250 µg). The study is enrolling an 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
Modernascientists 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.,EuropeandAustralia. 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. Modernahas built a fully integrated manufacturing plant which enables the promise of the technology platform.
Modernacurrently hasnine development candidatesin its prophylactic vaccines modality, including:
Vaccines against respiratory infections
· Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 withMerck)
· 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)
Vaccines against infections transmitted from mother to baby
· Cytomegalovirus (CMV) vaccine (mRNA-1647)
· Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infection
· Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date,Modernahas demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). Moderna’s CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.