Moderna has accelerated its manufacturing capacity for its COVID-19 vaccine candidate mRNA-1273 and additional future products through a 10-year agreement with Lonza announced today by the companies.
The companies agreed to establish manufacturing suites for Moderna at Lonza’s facilities in the U.S. and Switzerland for the production of mRNA-1273. Technology transfer is expected to begin in June, with the first batches of mRNA-1273 set to be manufactured at Lonza’s U.S. site in July.
Moderna and Lonza also said they 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, based on the currently expected dose of 50 mcg.
“Our common goal is to potentially enable manufacturing of up to 1 billion doses of mRNA-1273,” Moderna CEO Stéphane Bancel said in a statement. “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.”
Moderna said a portion of funding for establishing manufacturing operations at Lonza U.S.—the company did not specify how much—is covered by the up-to-$483 million awarded committed to the company by the Biomedical Advanced Research and Development Authority (BARDA), announced April 16.
BARDA agreed to help accelerate development of mRNA-1273 by supporting late-stage clinical development programs for the vaccine candidate. BARDA’s contract stretches 5-1/2 years, consisting of an approximately two-year base period-of-performance and a total contract period-of-performance (base period plus option exercises) of up to approximately five years and six months (if necessary), according to a regulatory filing.
Scaling up manufacturing
Moderna is the latest developer of a COVID-19 therapeutic to either announce a large-scale manufacturing agreement with a partner, or commit to larger-scale production on their own.
Yesterday, AstraZeneca joined the University of Oxford’s effort to develop ChAdOx1 nCoV-19 by agreeing to oversee global development, manufacturing, and distribution of the vaccine candidate that was created by researchers at the University, and is now in a human clinical trial launched last week.
On Wednesday, Janssen Pharmaceutical Cos. (Johnson & Johnson) signed an agreement with Catalent’s Biologics business unit to accelerate availability of segregated manufacturing capacity over coming months to facilitate large-scale commercial manufacturing of the lead vaccine candidate at Catalent’s facility in Bloomington, IN. Catalent said it planned to hire approximately 300 additional employees at Bloomington for the program starting in July 2020 to meet operational readiness and 24×7 manufacturing schedules by January 2021.
And on Tuesday, Pfizer CEO Albert Bourla told analysts on the company’s quarterly conference call that his company plans to manufacture “millions of doses” of BNT162 at its own risk by the end of 2020 “to accelerate availability in the event the development program is successful and we obtain regulatory approval” for emergency use authorization. Pfizer plans to rapidly scale up its production capacity “to produce potentially hundreds of millions of doses in 2021,” he said.
Bancel told Goldman Sachs representatives in March that Moderna was scaling up manufacturing capacity toward producing millions of doses per month, in the potential form of individual or multi-dose vials, the company disclosed in a regulatory filing. He said that while a commercially-available vaccine probably won’t be available for 12-18 months, a vaccine might be available in the fall of 2020 for use in treated patients under emergency use authorization.
“A significant opportunity”
“Moderna’s technology represents a significant opportunity to change the way we protect people against disease,” added 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.”
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 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 selected mRNA-1273 in collaboration with investigators from the Dale and Betty Bumpers Vaccine Research Center (VRC) at the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The first clinical batch, funded by the Coalition for Epidemic Preparedness Innovations (CEPI), was completed on February 7, and following analytical testing was shipped to NIH on February 24, 42 days from sequence selection.