Moderna Announces Award from U.S. Government Agency BARDA for up to $483 Million to Accelerate Development of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
Award will fund development of mRNA-1273 to FDA licensure
Award will fund manufacturing process scale-up to enable large-scale production in 2020 for pandemic response
NIH-led Phase 1 study of mRNA-1273 has completed enrollment of 3 dose cohorts (25 ?g, 100 ?g and 250 ?g); expanding to an additional 6 cohorts of older adults and elderly adults
Phase 2 study expected to begin in Q2 2020, following safety data from ongoing Phase 1 study
Moderna to hire up to 150 new team members to support efforts
Conference call to be held on Friday, April 17 at 8:00 a.m. ET
April 16, 2020 05:55 PM Eastern Daylight Time
CAMBRIDGE, Mass.--(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, today announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to accelerate development of the Company?s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
Under the terms of the agreement, BARDA will fund the advancement of mRNA-1273 to FDA licensure. A Phase 1 study of mRNA-1273 is being conducted by the National Institutes of Health (NIH). The Phase 1 open-label study, which began on March 16, 2020 has completed enrollment of the original study: 45 healthy adult volunteers ages 18 to 55 years in three dose cohorts (25 ?g, 100 ?g and 250 ?g). The NIH recently amended the Phase 1 protocol to include an additional six cohorts: three cohorts of older adults (ages 51-70) and three cohorts of elderly adults (age 71 and above). Enrollment for these cohorts is ongoing. If supported by safety data from the Phase 1 study, the Company intends to begin a Phase 2 study of mRNA-1273 under its own Investigational New Drug (IND) application in the second quarter of 2020. Subject to data from these studies and discussions with regulators, a Phase 3 study could begin as soon as fall, 2020. BARDA funding will support these late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020 to enable potential pandemic response. To support the scale-up, Moderna plans to hire up to 150 new team members in the U.S. this year. This includes a significant increase in its skilled manufacturing staff to expand manufacturing capacity from two shifts per day, 5 days per week to three shifts per day, 7 days per week, engineers to manage process scale-up, and clinical and regulatory staff to support clinical development. ?We are thankful for BARDA?s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2,? said St?phane Bancel, Moderna?s Chief Executive Officer. ?Time is of the essence to provide a vaccine against this pandemic virus. By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.? ?Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,? said BARDA Director Rick Bright, Ph.D. ?Delivering a safe and effective vaccine for a rapidly spreading virus requires accelerated action. BARDA?s goal is to have vaccine available as quickly as possible and preparing now for advanced stage clinical trials and production scale-up while the Phase 1 is underway could shave months off development of COVID-19 vaccines.? Conference Call and Webcast Information Moderna will host a live conference call and webcast at 8:00 a.m. ET on Friday, April 17, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 5115809. A webcast of the call will also be available under ?Events and Presentations? in the Investors section of the Moderna website at?investors.modernatx.com. The archived webcast will be available on Moderna?s website approximately two hours after the conference call. 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 NIH-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 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 six 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 announces award from BARDA for up to $483 million to accelerate development of mRNA vaccine (mRNA-1273) against novel coronavirus
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